CLINICAL RESEARCH
Europace (2015) 17, 1129–1135 doi:10.1093/europace/euu325
Cardiac electrophysiology
Patient discomfort following catheter ablation and rhythm device surgery Kerstin Bode 1*, Ole-A. Breithardt1, Manuela Kreuzhuber 1, Meinhard Mende 2, Philipp Sommer 1, Sergio Richter 1, Michael Doering 1, Borislav Dinov 1, Sascha Rolf1, Arash Arya1, Nikos Dagres 3, Gerhard Hindricks 1†, and Andreas Bollmann1† 1 Department of Electrophysiology, Heart Center Leipzig, University of Leipzig, Struempellstrasse 39, Leipzig 04289, Germany; 2Coordination Center for Clinical Trials, University of Leipzig, Leipzig, Germany; and 3Second Cardiology Department, Attikon University Hospital, University of Athens, Athens, Greece
Received 24 July 2014; accepted after revision 1 October 2014; online publish-ahead-of-print 8 December 2014
Aims
----------------------------------------------------------------------------------------------------------------------------------------------------------Keywords
Pain † Patient discomfort † Catheter ablation † Atrial fibrillation † Ventricular tachycardia † Cardiac device surgery
Introduction Electrophysiological studies and ablation procedures, as well as surgical interventions for implant, explant, replacement, or revision of cardiac implantable electronic devices (CIEDs) such as pacemakers and implantable cardiac defibrillators (ICD) are performed more frequently due to an ageing patient population, extended indications, and new techniques with better and improved outcomes. Invasive procedures can be associated with different degrees of pain not only during the procedure, but also in the early periods following the intervention. The common feature of any pain, regardless of its cause, is its subjective
nature. Untreated pain, however, is a substantial emotional distress for patients that increases the risk of immobilization, prolongs hospital stay, and has negative immunomodulating effects.1 As a result, adequate pain management should not only be an ethical concern, but also a fundamental requirement for faster recovery and improved patient satisfaction. Patient satisfaction is important as it influences future decisions related to likeliness of seeking healthcare for a specific procedure at a particular institution.2 Appropriate amounts of postoperative analgesia have, therefore, become an important measure of clinical performance for continuous quality improvement in patient management and are useful in benchmarking.3,4
* Corresponding author. Tel: +49 341 865 1413; fax: +49 341 865 1460. E-mail address: [email protected] †
Shared senior authorship.
Published on behalf of the European Society of Cardiology. All rights reserved. & The Author 2014. For permissions please email: [email protected].
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Proper management of post-interventional pain relieves unwarranted patient distress and enhances patient satisfaction. There have been only a limited number of investigations into patient discomfort following electrophysiological interventions. This study aims to quantify pain after interventional procedures, including ablation of atrial fibrillation (AF) or ventricular tachycardia (VT), as well as implant or explant of pacemakers or implantable cardioverter defibrillators. ..................................................................................................................................................................................... Methods One-hundred and two consecutive patients (mean age 66 years, 70 men) were asked to quantify post-interventional pain and results on a numeric rating scale (NRS 0–10) every 2 h during a period of 24 h after their intervention (49 ablations in deep propofol sedation, 53 device surgeries in local anaesthesia with mepivacaine 1%) and to specify the type of pain. Pain was classified as moderate to severe in case of NRS . 3. Post-operative pain medication included non-opioid and opioid analgesics as per the treating physicians’ discretion. Sixty-one patients (60%) suffered from moderate-to-severe pain within the first 24 h after the procedure, despite the use of analgesics in 47 patients (46%). Pain was present in an early period (0–6 h) in 54% and in a late period (8–24 h) in 40% of patients. Patients complained of back pain (44%), pain at the site of the device pocket (39%), pain at the groin after puncture (7%), and pericarditic pain (5%). Multivariate analysis identified female gender (P ¼ 0.046) associated with early post-interventional pain while age, diabetes mellitus, body mass index, type of intervention, and procedure time were not related to early or late post-interventional pain. ..................................................................................................................................................................................... Conclusion The findings highlight the high prevalence and the poor predictability of moderate-to-severe post-interventional pain within the first 24 h after catheter ablation and cardiac device surgery procedures, despite the use of peri-interventional analgesics. These findings highlight the need for more careful pain assessment and management programmes.
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What’s new? † Patient discomfort seems to be an underestimated circumstance after catheter ablation and cardiac device surgery. † This is the first study that highlights the high prevalence and the poor predictability of moderate-to-severe post-interventional pain within the first 24 h. † Overall 60% of patients suffered from moderate-to-severe pain within the first 24 h after procedure mostly caused by backpain and pain at the wound. † Pain was present in an early period (0– 6 h) in 54% and in a late period (8–24 h) in 40% of patients. † Female gender was associated with early post-interventional pain, while age, diabetes mellitus, body mass index, type of intervention, and procedure time were not related to early or late post-interventional pain. † These findings highlight the need for more careful pain assessment and management programmes.
Methods Patients The study was performed at the Department of Electrophysiology at the Heart Center in Leipzig, Germany in accordance with the Declaration of
Helsinki and was approved by the local clinical institution. After obtaining informed consent, 102 consecutive patients in the inpatient unit of the electrophysiology unit were enrolled within a 3-week period in June 2013. The subjects were asked to quantify post-interventional pain on a NRS (scale 0 – 10)10 every 2 h during a period of 24 h, following their electrophysiological intervention and to also specify the type of pain they experienced with multiple nominations possible. Pain management was left to the treating physicians’ discretion and the investigators did not intervene in patient care to obtain independent and unbiased data. The frequency of post-operative in-hospital oral and parenteral non-opioid and opioid analgesics use was also recorded.
Ablation procedures All AF and VT ablation procedures were performed under deep sedation and local anaesthesia at puncture site (with 20 mL Mepivacaine 1%). Intravenous propofol and fentanyl were administered initially as a bolus together with midazolam and then titrated to achieve deep sedation, defined as the absence of response to voice, but preserved response to painful stimulation.11 Monitoring included continuous measurements of the patient’s oxygen saturation levels, respiratory rate, heart rate, and invasive blood pressure. Duration of an ablation procedure was defined as the time span from femoral access puncture to the removal of the sheath. In AF patients, the antrum of the pulmonary veins was ablated via a single or double transseptal approach to achieve electrical isolation. AF ablation procedures were guided by an electroanatomic mapping system (EnSite NavX, St Jude Systems Medical Inc. or CARTO 3, Biosense Webster Inc.). After electrical isolation of the pulmonary veins, if the voltage map revealed areas of low voltage as a marker for electrical heterogeneity, additional ablation lines were performed to modify the substrate. Ventricular tachycardia ablations were performed with transvenous approach in case of right-sided VT and transseptal or retrograde approach in case of left-sided VTs. Catheter ablation was guided by a variety of techniques, including activation mapping, substrate mapping, or pace mapping with the help of an electroanatomical mapping system CARTO 3 (Biosense Webster Inc.). At the end of the procedure, programmed ventricular stimulation was done in all VT patients to achieve an endpoint of noninducibility.
Device procedures Implantation, replacement, and revision procedures were mostly done in conscious patients, whereas the single explant procedure in this series was done under deep sedation with fentanyl, midazolam, and propofol. The duration of CIED implant or explant procedure was defined as the time between the first incision and the last skin suture. All devices were implanted subcutaneously under local anaesthesia (with 40 mL Mepivacaine 1%) and patients received additional intravenous fentanyl for analgesia if necessary. Supplementary sedatives (midazolam alone or in combination with propofol or etomidate) were used temporarily in case of intraoperative defibrillation testing or when patients requested it. An infraclavicular incision was made parallel to the deltopectoral groove, and subclavian puncture was used as access for the leads. Wound closure was performed with subcutaneous and intracutaneous absorbable sutures. The single explant of a defibrillator with atrial and ventricular leads was achieved via the aid of a locking stylet.
Statistical analysis Continuous variables are expressed as mean + standard deviation. Categorical variables are reported in terms of numbers and proportions. Comparisons between the different groups of interventions and
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With the help of the validated and linear numeric rating scale (NRS), patients’ discomfort levels are easily quantifiable and can be used to guide analgesic therapy and to control therapeutic efficacy.5,6 With NRS, the patient himself or herself reports a pain level ranging between 0 and 10, where 0 indicates no pain and 10 indicates the worst pain the patient could imagine. NRS is considered to be the most sensitive and responsive scale compared with other measures of pain intensity, is easily applied by both patients and clinicians, and provides data for parametric analyses.7 Patients undergoing interventional electrophysiology procedures such as atrial fibrillation (AF) and ventricular tachycardia (VT) ablation or CIED surgery are restricted to a strict supine position for several hours during the procedure and thereafter. While ablation procedures are performed under deep sedation, device surgeries are usually performed under local anaesthesia. In each of these cases, after cessation of the procedure’s local or systemic anaesthetic effect, the onset of new post-operative pain or worsening of pre-existing chronic pain due to restricted movement can affect the patient’s comfort level. Additionally, patients with post-operative pain after device surgery are at risk to develop chronic shoulder dysfunction and pain.8,9 To the best of our knowledge, there have been no systematic investigations into patients’ discomfort levels and self-rated pain intensity after AF/VT ablation procedures or cardiac device surgeries. The aim of this study was to (1) characterize and quantify patient discomfort during the first 24 h, following one of the above-mentioned procedures, (2) and identify predictors for increased pain perception early after the intervention in patients treated at a high-volume institution specialized in interventional electrophysiology and device therapy.
K. Bode et al.
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Patient discomfort following catheter ablation and rhythm device surgery
Table 1 Patient and procedure characteristics Total
Ablation
Cardiac device surgery
Number of patients
102
49
53
Age (years) Female gender
66 + 12.7 32 (31%)
61.2 + 10.7 16 (33%)
70.6 + 12.8 16 (30%)
P-value
............................................................................................................................................................................... ,0.001 0.789
BMI (kg/m2)
29.5 + 4.9
30.8 + 4.9
28.3 + 4.6
0.010
Diabetes mellitus 2 Chronic pain
22 (22%) 16 (16%)
6 (12%) 7 (14%)
16 (30%) 9 (17%)
0.028 0.708
Procedure time (min)
93.8 + 63.3
143.7 + 47.3
47.7 + 34.8
,0.001
BMI, body mass index; min, minute.
Results Study population One-hundred and two consecutive patients undergoing 49 ablation procedures (48%) and 53 device surgeries (52%) were included. Patient and procedure characteristics are summarized and compared in Table 1. Ablations were performed for AF in 41 (40%) and VT in 8 (8%) cases. Device surgeries included 31 new implantations of single chamber (n ¼ 9), dual chamber (n ¼ 16), and CRT devices (n ¼ 6), 8 generator replacements due to battery depletion, 11 lead revisions, 2 pocket revisions due to imminent perforation, and 1 system explant due to infection. During ablation procedures patients received a mean of 0.063 + 0.034 mg of fentanyl, mean of 108 + 64.6 mg of propofol, and a mean of 2.2 + 1.5 mg of midazolam. During rhythm device surgery additional intravenous fentanyl for analgesia was administered in 20 patients with a mean dose of 0.061 + 0.034 mg per patient). Sedatives were used in 28 device patients. Mean dose were: midazolam (28 patients) 2.9 + 1.2 mg, etomidate (12 patients) 11.3 + 3.4 mg, and propofol (8 patients) 99.4 + 81.1 mg.
Data point collection Out of 1326 possible data points, 1104 were collected successfully. The missing data points were due to patients sleeping and/or early
discharge. Each patient had a median of 13 (mean 10.8) collected data points (min ¼ 3, max ¼ 13, 25% quartile ¼ 9, 75% quartile ¼ 13) in the first 24 h following the intervention.
Patient discomfort Out of 102 patients, 15 (15%) reported pre-existing chronic low-to-moderate pain before their intervention with an average NRS value of 2 (range 1 –4). Overall, 61 out of 102 patients (60%) suffered from moderateto-severe pain (NRS . 3) within the first 24 h after the procedure (Figure 1A), despite the use of post-interventional analgesics in 47 patients (46%). Out of these 61 patients with moderate-to-severe pain intensity, 41 (67%) disclosed their pain to the treating staff and actively requested pain relief in which case, 38 out of 41 patients (93%) received analgesics. Out of 102 patients, 9 received pain killers for prophylactic reasons or at NRS ≤ 3. Pain was disclosed early (0–6 h) in 55 (54%) and late (8–24 h) in 40 (40%) patients (Figure 1B and C ). When pain perception was classified according to the type of intervention and temporal pattern, there were no significant differences in the number of patients within the ablation group and the device group suffering from early post-interventional pain with NRS . 3 [61 vs. 47%, respectively, odds ratio (OR) ¼ 1.77, 95% confidence interval (CI): 0.80 –3.89, P ¼ 0.155]. Patients in both ablation and device surgery groups experienced similar levels of late post-interventional pain with NRS . 3 (47 vs. 32%, respectively, OR ¼ 0.53, 95% CI: 0.23 –1.19, P ¼ 0.12). However, the proportion of patients with pain in the ablation group decreased significantly between the early and late post-interventional time periods (OR ¼ 0.301, 95% CI: 0.117– 0.743, P ¼ 0.003) (Table 2, Figure 2). Patients affected by pain complained of back pain (44%), pain at the site of device implantation (39%), pain in the groin region after puncture (7%), pericarditic pain (5%), and pain at other sites (8%) (Figure 3). Given that the patients’ discomfort levels reached the moderate level of NRS values .3 at different time points, the absolute number of patients with moderate-to-severe pain varied, but never exceeded 45% at any given time point. After 22 h, the number of patients with an NRS . 3 decreased to ,10% (Figure 4). A comparison between patients with pain levels NRS . 3 and those with NRS ≤ 3 is shown in Table 3. In an unadjusted multivariate analysis, longer procedure duration (OR ¼ 1.007 min21 increase,
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temporal occurrence of pain were performed using Student’s t-test for continuous and x2 test for categorical variables. McNemar test was applied to compare early and late pain within the ablation group. Uniand multivariate logistic regression analysis was used to identify variables associated with pain perception. For this purpose age, female sex, body mass index (BMI), diabetes mellitus, type of intervention, duration of intervention, and chronic pain were included in a stepwise forward procedure. The selected variables were fit into a final model to get the correct estimates for the odds ratio. A P-value of ,0.05 was considered statistically significant. Conventionally, NRS levels are used to classify three pain categories low/moderate/severe (NRS 0 – 3, 4 – 5, ≥6, respectively). As pain therapy is advised at NRS . 3,12 two categories of pain based on therapy requirements were considered for our analyses (NRS ≤ 3, NRS . 3). In the case of at least one self-reported NRS . 3, presence of post-operative pain was considered positive. For the temporal analysis, two groups were compared according to early post-interventional pain (0 –6 h) and late post-interventional pain (8 – 24 h).
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A
95% CI: 1.001 –1.014, P ¼ 0.047) and female gender (OR ¼ 2.501, 95% CI: 1.015 –6.158, P ¼ 0.046) were associated with early postinterventional pain of NRS . 3. Since procedure duration lasted longer in ablations compared with device surgery (Table 1), multivariate analysis adjusting for procedure type was performed and revealed female gender as the only variable associated with early postinterventional pain of NRS . 3 (OR ¼ 2.502, 95% CI: 1.016– 6.163, P ¼ 0.046). There was a trend towards an association between chronic pain and late post-interventional pain (OR ¼ 3.0, 95% CI: 0.99–9.07, P ¼ 0.052). A multivariable association with all other variables could not be detected.
Post-operative pain (0–24h)
40% 60%
Discussion
B Early post-operative pain (0–6h)
46% 54%
40% 60%
NRS > 3
NRS £ 3
Figure 1 Prevalence of post-operative pain according to NRS ≤3 vs. . 3 [A: total (0 – 24 h); B: early (0 – 6 h); C: late (8– 24 h)].
Table 2 Pain NRS > 3 according to intervention Total
Ablation
Rhythm device surgery
OR
95% confidence interval
P-value
............................................................................................................................................................................... NRS . 3, 0– 24 h
61/102 (60%)
33/49 (67%)
28/53 (53%)
–
NRS . 3, 0– 6 h
55/102 (54%)
30/49 (61%)
25/53 (47%)
1.77
0.804
3.89
0.155
NRS . 3, 8– 24 h
40/100 (40%)
15/47a (32%)
25/53 (47%)
0.525
0.232
1.19
0.120
h, hour; NRS, numeric rating scale. a The change of proportion of patients with pain NRS . 3 in the ablation group was significant.
0.135
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C Late post-operative pain (8–24h)
To the best of our knowledge, this is the first study that systematically and prospectively quantified patient pain perception over 24 h following interventional electrophysiological procedures. The primary aim of the study was to obtain reliable information on the type, severity, and the time course of post-operative pain perception after typical interventional electrophysiological procedures. The study revealed that 60% of patients suffered from moderate-to-severe pain (NRS . 3) within a period of 24 h despite peri- and postinterventional analgesia, when pain management was as per the treating physicians’ discretion without a standardized pain assessment and management programme. Fifty five of 102 patients (54%) complained of moderate-to-severe pain within the first 6 h. Thereafter, a noticeable proportion of patients (40%) still reported new or continued moderate-to-severe pain (NRS . 3) even 8 –24 h after the procedure. AF or VT ablation procedures were more frequently associated with early postinterventional pain during bed rest. In contrast, the proportion of patients with moderate-to-severe pain in the CIED surgery group did not change over time, since pain at the wound sustained longer especially after easing of local anaesthetic effects. Patients’ self-rated levels of pain reached NRS . 3 at different time points, and therefore, the absolute number of patients with pain varied over time, but never exceeded 45% at any given time point. After 22 h, only a minority (,10%) still reported moderate-to-severe pain. In an investigation by Ezzat et al. (2013),13 patients were asked about their level of satisfaction 1 week after discharge following an AF ablation procedure. This study also reported a considerable
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Patient discomfort following catheter ablation and rhythm device surgery
proportion of patients (56%) complaining of pain after ablation.13 Back pain was also reported as a relevant problem after coronary interventions, favouring changing body position for pain relief.14 – 17 Implantable cardiac defibrillators have been associated with postoperative discomfort and pain in previous studies. Chronic shoulder pain and disability was described in 131 (54%) patients .3 years after ICD implantation. The only predictor for shoulder pain and disability was the number of implanted leads.18 Diemberger et al.,8 however, describe a recovery of shoulder impairment within 3 months after ICD implantation. Bollmann et al. 19 investigated pain perception 24 h after subpectoral (86%) and subcutaneous (14%) ICD implantation under conscious sedation and found the mean post-operative visual analogue scale (VAS) score (pain score at VAS) to be 34 + 20. Our study focused on the early time period after the intervention or surgery and was not designed to evaluate patients’ discomfort levels after the initial 24 h. Even though the results are not directly comparable, they suggest that optimized pain management regimen can affect a large proportion of patients. Previous studies have suggested that post-operative and procedural self-reported pain may be more severe among women than men.20
In our study, female gender was associated with more moderateto-severe pain levels during the early post-operative phases (0–6 h) compared with men. However, there were no gender differences with respect to late post-operative pain. Our results of 60% of patients complaining of moderate-to-severe pain within the first 24 h after electrophysiological interventions may have been due to the treating clinicians’ lack of awareness of such potential levels of pain intensity after interventional electrophysiology procedures. An additional explanation may be the patients’ passive or shy behaviour where only 67% were actively seeking help for pain relief. It is possible that patients had not received information about different post-operative pain therapy options, were not asked about their discomfort levels, were afraid of inconveniencing the medical staff, or thought that pain after an intervention was acceptable and had to be tolerated before it ceases without therapy. Following this study, a local pain assessment and management programme was implemented at our institution to address the observed high levels of post-operative pain in our patients (see Appendix 1 for the new Heart Center Leipzig policies).
Limitations 100% 90% 80% 70% 60%
NRS 0–3 NRS 4–5 NRS 6–10
50% 40%
Conclusion
30% 20% 10% 0% Ablation, early
Ablation, late
Devices, early
Devices, late
Figure 2 Differences in the percentage of patients experiencing different levels of pain according to temporal pattern and type of intervention.
This is the first study investigating patient pain intensity after standard interventional electrophysiological procedures. The findings highlight the high prevalence and poor predictability of moderateto-severe post-interventional pain within the first 24 h after catheter ablation and cardiac device surgery procedures. Consequently, pain assessment and management programmes (see Appendix 1 for the Heart Center Leipzig policies) are needed and their evaluation deserves attention. Predictors such as female gender may help to identify patients for prophylactic analgesics use. Effective postinterventional pain management increases patient satisfaction and
50
Percentage of patients
45
44 39
40 35 30 25 20 15 10
7
5
8 5
0 Backpain
Figure 3 Type of pain in the pain affected patient cohort.
Wound
Groin
Pericarditic
Others
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This was a single-centre study investigating different kinds of interventions, but this was a reflection of a typical patient cohort at our inpatient electrophysiological unit. The study was limited to the first 24 h after the intervention and we have not assessed pain levels during the intervention and after discharge.
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K. Bode et al.
100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% NRS 0–3 NRS 4–5 NRS 6–10
0 61 19 19
2 65 17 19
4 57 26 17
6 53 24 19
8 61 19 12
10 64 15 9
12 66 11 8
14 67 12 6
16 61 12 7
18 58 17 2
20 60 8 1
22 60 4 1
24 56 2 1
Figure 4 Temporal patterns of post-interventional pain (during sleep or in case of early discharge, there were no NRS values collected and therefore absolute numbers of patients could be ,102).
Early severe pain 0 –6
.............................................................. NRS ≤ 3
NRS > 3
Late severe pain 8– 24 h
.............................................................
P-value
NRS ≤ 3
NRS > 3
P-value
............................................................................................................................................................................... N¼
47
55
60
40
Age (years) Female gender (%)
65.6 + 11.4 10 (21%)
66.4 + 13.8 22 (40%)
0.746 0.042
65.8 + 10.4 16 (27%)
66.9 + 15.7 15 (38%)
0.67 0.251
BMI (kg/m2)
29.3 + 4.7
29.7 + 5.1
0.686
29.7 + 4.7
28.9 + 5.1
0.451
Diabetes mellitus 2 (%)
11 (23%)
11 (20%)
0.677
13 (22%)
9 (23%)
0.921
Chronic pain Intervention
5 (11%)
11 (20%)
0.195
6 (37.5%)
10 (62.5)
0.052
Ablation
19 (40%)
30 (55%)
0.155
32 (53%)
15 (38%)
0.120
28 (60%) 80.1 + 59.1
25 (45%) 105.5 + 64.9
0.043
28 (47%) 97.9 + 61.3
25 (62%) 86.2 + 65.9
0.364
Device surgery Duration (min)
BMI, body mass index; h, hours; min, minute; NRS, numeric rating scale.
well being and is, therefore, not only an important treatment quality measure, but also an ethical responsibility. † Conflict of interest: none declared. †
Appendix 1
†
Heart Center Leipzig policies According to the results presented here, pain management was adapted at our institution as follows: † The clinicians are advised to (i) pay a closer attention to the continuation of domestic pain medication, (ii) prescribe complete
†
recommended doses of painkillers, and (iii) inform patients on all given pain medications. Patients are now actively advised to disclose any pain they may experience. Nurses have been advised to ask patients about their pain intensity after interventions with the help of NRS every 2 h on the day of procedure. Analgesics are now offered to the patient at NRS . 3 or if the patient asks for it at a lower pain level. Due to the potential side effects of analgesics, the fact that pain resolved to low levels within the first 24 h in most of our patients, and the fact that 40% of our patients denied moderate-to-severe pain within the first 24 h, pain killers for acute post-interventional pain are prescribed on demand and not after a fixed time scheme.
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Table 3 Univariate analysis
Patient discomfort following catheter ablation and rhythm device surgery
† Oral non-opioid analgesics on demand are prescribed in the patient folder by doctors the evening before the intervention according the patient’s co-morbidities and laboratory results. On the day of the intervention, nurses are allowed to give this prescribed medication if pain is not caused by any other critical issues. Typical situations are back pain due to bed rest and pain at the device wound or groins due to incision or puncture. † Thirty to 60 min after the administration of pain killers, a reevaluation of pain has to be done by nurses and if NRS is still .3, doctors have to be informed and again have to exclude acute reasons for pain requiring further diagnostic and therapy. When indicated, patients are treated with opioids, such as subcutaneous Piritramid with continuous monitoring of vital signs. † A pain nurse attends to patients with chronic pain who are unresponsive to therapy. † Lastly, doctors and nurses are educated on acute and chronic pain management, pain evaluation, WHO guidelines, as well as medical and physical therapy options on a regular basis.
References
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Europace (2015) 17, 1129–1135 doi:10.1093/europace/euu325
Cardiac electrophysiology
Patient discomfort following catheter ablation and rhythm device surgery Kerstin Bode 1*, Ole-A. Breithardt1, Manuela Kreuzhuber 1, Meinhard Mende 2, Philipp Sommer 1, Sergio Richter 1, Michael Doering 1, Borislav Dinov 1, Sascha Rolf1, Arash Arya1, Nikos Dagres 3, Gerhard Hindricks 1†, and Andreas Bollmann1† 1 Department of Electrophysiology, Heart Center Leipzig, University of Leipzig, Struempellstrasse 39, Leipzig 04289, Germany; 2Coordination Center for Clinical Trials, University of Leipzig, Leipzig, Germany; and 3Second Cardiology Department, Attikon University Hospital, University of Athens, Athens, Greece
Received 24 July 2014; accepted after revision 1 October 2014; online publish-ahead-of-print 8 December 2014
Aims
----------------------------------------------------------------------------------------------------------------------------------------------------------Keywords
Pain † Patient discomfort † Catheter ablation † Atrial fibrillation † Ventricular tachycardia † Cardiac device surgery
Introduction Electrophysiological studies and ablation procedures, as well as surgical interventions for implant, explant, replacement, or revision of cardiac implantable electronic devices (CIEDs) such as pacemakers and implantable cardiac defibrillators (ICD) are performed more frequently due to an ageing patient population, extended indications, and new techniques with better and improved outcomes. Invasive procedures can be associated with different degrees of pain not only during the procedure, but also in the early periods following the intervention. The common feature of any pain, regardless of its cause, is its subjective
nature. Untreated pain, however, is a substantial emotional distress for patients that increases the risk of immobilization, prolongs hospital stay, and has negative immunomodulating effects.1 As a result, adequate pain management should not only be an ethical concern, but also a fundamental requirement for faster recovery and improved patient satisfaction. Patient satisfaction is important as it influences future decisions related to likeliness of seeking healthcare for a specific procedure at a particular institution.2 Appropriate amounts of postoperative analgesia have, therefore, become an important measure of clinical performance for continuous quality improvement in patient management and are useful in benchmarking.3,4
* Corresponding author. Tel: +49 341 865 1413; fax: +49 341 865 1460. E-mail address: [email protected] †
Shared senior authorship.
Published on behalf of the European Society of Cardiology. All rights reserved. & The Author 2014. For permissions please email: [email protected].
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Proper management of post-interventional pain relieves unwarranted patient distress and enhances patient satisfaction. There have been only a limited number of investigations into patient discomfort following electrophysiological interventions. This study aims to quantify pain after interventional procedures, including ablation of atrial fibrillation (AF) or ventricular tachycardia (VT), as well as implant or explant of pacemakers or implantable cardioverter defibrillators. ..................................................................................................................................................................................... Methods One-hundred and two consecutive patients (mean age 66 years, 70 men) were asked to quantify post-interventional pain and results on a numeric rating scale (NRS 0–10) every 2 h during a period of 24 h after their intervention (49 ablations in deep propofol sedation, 53 device surgeries in local anaesthesia with mepivacaine 1%) and to specify the type of pain. Pain was classified as moderate to severe in case of NRS . 3. Post-operative pain medication included non-opioid and opioid analgesics as per the treating physicians’ discretion. Sixty-one patients (60%) suffered from moderate-to-severe pain within the first 24 h after the procedure, despite the use of analgesics in 47 patients (46%). Pain was present in an early period (0–6 h) in 54% and in a late period (8–24 h) in 40% of patients. Patients complained of back pain (44%), pain at the site of the device pocket (39%), pain at the groin after puncture (7%), and pericarditic pain (5%). Multivariate analysis identified female gender (P ¼ 0.046) associated with early post-interventional pain while age, diabetes mellitus, body mass index, type of intervention, and procedure time were not related to early or late post-interventional pain. ..................................................................................................................................................................................... Conclusion The findings highlight the high prevalence and the poor predictability of moderate-to-severe post-interventional pain within the first 24 h after catheter ablation and cardiac device surgery procedures, despite the use of peri-interventional analgesics. These findings highlight the need for more careful pain assessment and management programmes.
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What’s new? † Patient discomfort seems to be an underestimated circumstance after catheter ablation and cardiac device surgery. † This is the first study that highlights the high prevalence and the poor predictability of moderate-to-severe post-interventional pain within the first 24 h. † Overall 60% of patients suffered from moderate-to-severe pain within the first 24 h after procedure mostly caused by backpain and pain at the wound. † Pain was present in an early period (0– 6 h) in 54% and in a late period (8–24 h) in 40% of patients. † Female gender was associated with early post-interventional pain, while age, diabetes mellitus, body mass index, type of intervention, and procedure time were not related to early or late post-interventional pain. † These findings highlight the need for more careful pain assessment and management programmes.
Methods Patients The study was performed at the Department of Electrophysiology at the Heart Center in Leipzig, Germany in accordance with the Declaration of
Helsinki and was approved by the local clinical institution. After obtaining informed consent, 102 consecutive patients in the inpatient unit of the electrophysiology unit were enrolled within a 3-week period in June 2013. The subjects were asked to quantify post-interventional pain on a NRS (scale 0 – 10)10 every 2 h during a period of 24 h, following their electrophysiological intervention and to also specify the type of pain they experienced with multiple nominations possible. Pain management was left to the treating physicians’ discretion and the investigators did not intervene in patient care to obtain independent and unbiased data. The frequency of post-operative in-hospital oral and parenteral non-opioid and opioid analgesics use was also recorded.
Ablation procedures All AF and VT ablation procedures were performed under deep sedation and local anaesthesia at puncture site (with 20 mL Mepivacaine 1%). Intravenous propofol and fentanyl were administered initially as a bolus together with midazolam and then titrated to achieve deep sedation, defined as the absence of response to voice, but preserved response to painful stimulation.11 Monitoring included continuous measurements of the patient’s oxygen saturation levels, respiratory rate, heart rate, and invasive blood pressure. Duration of an ablation procedure was defined as the time span from femoral access puncture to the removal of the sheath. In AF patients, the antrum of the pulmonary veins was ablated via a single or double transseptal approach to achieve electrical isolation. AF ablation procedures were guided by an electroanatomic mapping system (EnSite NavX, St Jude Systems Medical Inc. or CARTO 3, Biosense Webster Inc.). After electrical isolation of the pulmonary veins, if the voltage map revealed areas of low voltage as a marker for electrical heterogeneity, additional ablation lines were performed to modify the substrate. Ventricular tachycardia ablations were performed with transvenous approach in case of right-sided VT and transseptal or retrograde approach in case of left-sided VTs. Catheter ablation was guided by a variety of techniques, including activation mapping, substrate mapping, or pace mapping with the help of an electroanatomical mapping system CARTO 3 (Biosense Webster Inc.). At the end of the procedure, programmed ventricular stimulation was done in all VT patients to achieve an endpoint of noninducibility.
Device procedures Implantation, replacement, and revision procedures were mostly done in conscious patients, whereas the single explant procedure in this series was done under deep sedation with fentanyl, midazolam, and propofol. The duration of CIED implant or explant procedure was defined as the time between the first incision and the last skin suture. All devices were implanted subcutaneously under local anaesthesia (with 40 mL Mepivacaine 1%) and patients received additional intravenous fentanyl for analgesia if necessary. Supplementary sedatives (midazolam alone or in combination with propofol or etomidate) were used temporarily in case of intraoperative defibrillation testing or when patients requested it. An infraclavicular incision was made parallel to the deltopectoral groove, and subclavian puncture was used as access for the leads. Wound closure was performed with subcutaneous and intracutaneous absorbable sutures. The single explant of a defibrillator with atrial and ventricular leads was achieved via the aid of a locking stylet.
Statistical analysis Continuous variables are expressed as mean + standard deviation. Categorical variables are reported in terms of numbers and proportions. Comparisons between the different groups of interventions and
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With the help of the validated and linear numeric rating scale (NRS), patients’ discomfort levels are easily quantifiable and can be used to guide analgesic therapy and to control therapeutic efficacy.5,6 With NRS, the patient himself or herself reports a pain level ranging between 0 and 10, where 0 indicates no pain and 10 indicates the worst pain the patient could imagine. NRS is considered to be the most sensitive and responsive scale compared with other measures of pain intensity, is easily applied by both patients and clinicians, and provides data for parametric analyses.7 Patients undergoing interventional electrophysiology procedures such as atrial fibrillation (AF) and ventricular tachycardia (VT) ablation or CIED surgery are restricted to a strict supine position for several hours during the procedure and thereafter. While ablation procedures are performed under deep sedation, device surgeries are usually performed under local anaesthesia. In each of these cases, after cessation of the procedure’s local or systemic anaesthetic effect, the onset of new post-operative pain or worsening of pre-existing chronic pain due to restricted movement can affect the patient’s comfort level. Additionally, patients with post-operative pain after device surgery are at risk to develop chronic shoulder dysfunction and pain.8,9 To the best of our knowledge, there have been no systematic investigations into patients’ discomfort levels and self-rated pain intensity after AF/VT ablation procedures or cardiac device surgeries. The aim of this study was to (1) characterize and quantify patient discomfort during the first 24 h, following one of the above-mentioned procedures, (2) and identify predictors for increased pain perception early after the intervention in patients treated at a high-volume institution specialized in interventional electrophysiology and device therapy.
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Patient discomfort following catheter ablation and rhythm device surgery
Table 1 Patient and procedure characteristics Total
Ablation
Cardiac device surgery
Number of patients
102
49
53
Age (years) Female gender
66 + 12.7 32 (31%)
61.2 + 10.7 16 (33%)
70.6 + 12.8 16 (30%)
P-value
............................................................................................................................................................................... ,0.001 0.789
BMI (kg/m2)
29.5 + 4.9
30.8 + 4.9
28.3 + 4.6
0.010
Diabetes mellitus 2 Chronic pain
22 (22%) 16 (16%)
6 (12%) 7 (14%)
16 (30%) 9 (17%)
0.028 0.708
Procedure time (min)
93.8 + 63.3
143.7 + 47.3
47.7 + 34.8
,0.001
BMI, body mass index; min, minute.
Results Study population One-hundred and two consecutive patients undergoing 49 ablation procedures (48%) and 53 device surgeries (52%) were included. Patient and procedure characteristics are summarized and compared in Table 1. Ablations were performed for AF in 41 (40%) and VT in 8 (8%) cases. Device surgeries included 31 new implantations of single chamber (n ¼ 9), dual chamber (n ¼ 16), and CRT devices (n ¼ 6), 8 generator replacements due to battery depletion, 11 lead revisions, 2 pocket revisions due to imminent perforation, and 1 system explant due to infection. During ablation procedures patients received a mean of 0.063 + 0.034 mg of fentanyl, mean of 108 + 64.6 mg of propofol, and a mean of 2.2 + 1.5 mg of midazolam. During rhythm device surgery additional intravenous fentanyl for analgesia was administered in 20 patients with a mean dose of 0.061 + 0.034 mg per patient). Sedatives were used in 28 device patients. Mean dose were: midazolam (28 patients) 2.9 + 1.2 mg, etomidate (12 patients) 11.3 + 3.4 mg, and propofol (8 patients) 99.4 + 81.1 mg.
Data point collection Out of 1326 possible data points, 1104 were collected successfully. The missing data points were due to patients sleeping and/or early
discharge. Each patient had a median of 13 (mean 10.8) collected data points (min ¼ 3, max ¼ 13, 25% quartile ¼ 9, 75% quartile ¼ 13) in the first 24 h following the intervention.
Patient discomfort Out of 102 patients, 15 (15%) reported pre-existing chronic low-to-moderate pain before their intervention with an average NRS value of 2 (range 1 –4). Overall, 61 out of 102 patients (60%) suffered from moderateto-severe pain (NRS . 3) within the first 24 h after the procedure (Figure 1A), despite the use of post-interventional analgesics in 47 patients (46%). Out of these 61 patients with moderate-to-severe pain intensity, 41 (67%) disclosed their pain to the treating staff and actively requested pain relief in which case, 38 out of 41 patients (93%) received analgesics. Out of 102 patients, 9 received pain killers for prophylactic reasons or at NRS ≤ 3. Pain was disclosed early (0–6 h) in 55 (54%) and late (8–24 h) in 40 (40%) patients (Figure 1B and C ). When pain perception was classified according to the type of intervention and temporal pattern, there were no significant differences in the number of patients within the ablation group and the device group suffering from early post-interventional pain with NRS . 3 [61 vs. 47%, respectively, odds ratio (OR) ¼ 1.77, 95% confidence interval (CI): 0.80 –3.89, P ¼ 0.155]. Patients in both ablation and device surgery groups experienced similar levels of late post-interventional pain with NRS . 3 (47 vs. 32%, respectively, OR ¼ 0.53, 95% CI: 0.23 –1.19, P ¼ 0.12). However, the proportion of patients with pain in the ablation group decreased significantly between the early and late post-interventional time periods (OR ¼ 0.301, 95% CI: 0.117– 0.743, P ¼ 0.003) (Table 2, Figure 2). Patients affected by pain complained of back pain (44%), pain at the site of device implantation (39%), pain in the groin region after puncture (7%), pericarditic pain (5%), and pain at other sites (8%) (Figure 3). Given that the patients’ discomfort levels reached the moderate level of NRS values .3 at different time points, the absolute number of patients with moderate-to-severe pain varied, but never exceeded 45% at any given time point. After 22 h, the number of patients with an NRS . 3 decreased to ,10% (Figure 4). A comparison between patients with pain levels NRS . 3 and those with NRS ≤ 3 is shown in Table 3. In an unadjusted multivariate analysis, longer procedure duration (OR ¼ 1.007 min21 increase,
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temporal occurrence of pain were performed using Student’s t-test for continuous and x2 test for categorical variables. McNemar test was applied to compare early and late pain within the ablation group. Uniand multivariate logistic regression analysis was used to identify variables associated with pain perception. For this purpose age, female sex, body mass index (BMI), diabetes mellitus, type of intervention, duration of intervention, and chronic pain were included in a stepwise forward procedure. The selected variables were fit into a final model to get the correct estimates for the odds ratio. A P-value of ,0.05 was considered statistically significant. Conventionally, NRS levels are used to classify three pain categories low/moderate/severe (NRS 0 – 3, 4 – 5, ≥6, respectively). As pain therapy is advised at NRS . 3,12 two categories of pain based on therapy requirements were considered for our analyses (NRS ≤ 3, NRS . 3). In the case of at least one self-reported NRS . 3, presence of post-operative pain was considered positive. For the temporal analysis, two groups were compared according to early post-interventional pain (0 –6 h) and late post-interventional pain (8 – 24 h).
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A
95% CI: 1.001 –1.014, P ¼ 0.047) and female gender (OR ¼ 2.501, 95% CI: 1.015 –6.158, P ¼ 0.046) were associated with early postinterventional pain of NRS . 3. Since procedure duration lasted longer in ablations compared with device surgery (Table 1), multivariate analysis adjusting for procedure type was performed and revealed female gender as the only variable associated with early postinterventional pain of NRS . 3 (OR ¼ 2.502, 95% CI: 1.016– 6.163, P ¼ 0.046). There was a trend towards an association between chronic pain and late post-interventional pain (OR ¼ 3.0, 95% CI: 0.99–9.07, P ¼ 0.052). A multivariable association with all other variables could not be detected.
Post-operative pain (0–24h)
40% 60%
Discussion
B Early post-operative pain (0–6h)
46% 54%
40% 60%
NRS > 3
NRS £ 3
Figure 1 Prevalence of post-operative pain according to NRS ≤3 vs. . 3 [A: total (0 – 24 h); B: early (0 – 6 h); C: late (8– 24 h)].
Table 2 Pain NRS > 3 according to intervention Total
Ablation
Rhythm device surgery
OR
95% confidence interval
P-value
............................................................................................................................................................................... NRS . 3, 0– 24 h
61/102 (60%)
33/49 (67%)
28/53 (53%)
–
NRS . 3, 0– 6 h
55/102 (54%)
30/49 (61%)
25/53 (47%)
1.77
0.804
3.89
0.155
NRS . 3, 8– 24 h
40/100 (40%)
15/47a (32%)
25/53 (47%)
0.525
0.232
1.19
0.120
h, hour; NRS, numeric rating scale. a The change of proportion of patients with pain NRS . 3 in the ablation group was significant.
0.135
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C Late post-operative pain (8–24h)
To the best of our knowledge, this is the first study that systematically and prospectively quantified patient pain perception over 24 h following interventional electrophysiological procedures. The primary aim of the study was to obtain reliable information on the type, severity, and the time course of post-operative pain perception after typical interventional electrophysiological procedures. The study revealed that 60% of patients suffered from moderate-to-severe pain (NRS . 3) within a period of 24 h despite peri- and postinterventional analgesia, when pain management was as per the treating physicians’ discretion without a standardized pain assessment and management programme. Fifty five of 102 patients (54%) complained of moderate-to-severe pain within the first 6 h. Thereafter, a noticeable proportion of patients (40%) still reported new or continued moderate-to-severe pain (NRS . 3) even 8 –24 h after the procedure. AF or VT ablation procedures were more frequently associated with early postinterventional pain during bed rest. In contrast, the proportion of patients with moderate-to-severe pain in the CIED surgery group did not change over time, since pain at the wound sustained longer especially after easing of local anaesthetic effects. Patients’ self-rated levels of pain reached NRS . 3 at different time points, and therefore, the absolute number of patients with pain varied over time, but never exceeded 45% at any given time point. After 22 h, only a minority (,10%) still reported moderate-to-severe pain. In an investigation by Ezzat et al. (2013),13 patients were asked about their level of satisfaction 1 week after discharge following an AF ablation procedure. This study also reported a considerable
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Patient discomfort following catheter ablation and rhythm device surgery
proportion of patients (56%) complaining of pain after ablation.13 Back pain was also reported as a relevant problem after coronary interventions, favouring changing body position for pain relief.14 – 17 Implantable cardiac defibrillators have been associated with postoperative discomfort and pain in previous studies. Chronic shoulder pain and disability was described in 131 (54%) patients .3 years after ICD implantation. The only predictor for shoulder pain and disability was the number of implanted leads.18 Diemberger et al.,8 however, describe a recovery of shoulder impairment within 3 months after ICD implantation. Bollmann et al. 19 investigated pain perception 24 h after subpectoral (86%) and subcutaneous (14%) ICD implantation under conscious sedation and found the mean post-operative visual analogue scale (VAS) score (pain score at VAS) to be 34 + 20. Our study focused on the early time period after the intervention or surgery and was not designed to evaluate patients’ discomfort levels after the initial 24 h. Even though the results are not directly comparable, they suggest that optimized pain management regimen can affect a large proportion of patients. Previous studies have suggested that post-operative and procedural self-reported pain may be more severe among women than men.20
In our study, female gender was associated with more moderateto-severe pain levels during the early post-operative phases (0–6 h) compared with men. However, there were no gender differences with respect to late post-operative pain. Our results of 60% of patients complaining of moderate-to-severe pain within the first 24 h after electrophysiological interventions may have been due to the treating clinicians’ lack of awareness of such potential levels of pain intensity after interventional electrophysiology procedures. An additional explanation may be the patients’ passive or shy behaviour where only 67% were actively seeking help for pain relief. It is possible that patients had not received information about different post-operative pain therapy options, were not asked about their discomfort levels, were afraid of inconveniencing the medical staff, or thought that pain after an intervention was acceptable and had to be tolerated before it ceases without therapy. Following this study, a local pain assessment and management programme was implemented at our institution to address the observed high levels of post-operative pain in our patients (see Appendix 1 for the new Heart Center Leipzig policies).
Limitations 100% 90% 80% 70% 60%
NRS 0–3 NRS 4–5 NRS 6–10
50% 40%
Conclusion
30% 20% 10% 0% Ablation, early
Ablation, late
Devices, early
Devices, late
Figure 2 Differences in the percentage of patients experiencing different levels of pain according to temporal pattern and type of intervention.
This is the first study investigating patient pain intensity after standard interventional electrophysiological procedures. The findings highlight the high prevalence and poor predictability of moderateto-severe post-interventional pain within the first 24 h after catheter ablation and cardiac device surgery procedures. Consequently, pain assessment and management programmes (see Appendix 1 for the Heart Center Leipzig policies) are needed and their evaluation deserves attention. Predictors such as female gender may help to identify patients for prophylactic analgesics use. Effective postinterventional pain management increases patient satisfaction and
50
Percentage of patients
45
44 39
40 35 30 25 20 15 10
7
5
8 5
0 Backpain
Figure 3 Type of pain in the pain affected patient cohort.
Wound
Groin
Pericarditic
Others
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This was a single-centre study investigating different kinds of interventions, but this was a reflection of a typical patient cohort at our inpatient electrophysiological unit. The study was limited to the first 24 h after the intervention and we have not assessed pain levels during the intervention and after discharge.
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100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% NRS 0–3 NRS 4–5 NRS 6–10
0 61 19 19
2 65 17 19
4 57 26 17
6 53 24 19
8 61 19 12
10 64 15 9
12 66 11 8
14 67 12 6
16 61 12 7
18 58 17 2
20 60 8 1
22 60 4 1
24 56 2 1
Figure 4 Temporal patterns of post-interventional pain (during sleep or in case of early discharge, there were no NRS values collected and therefore absolute numbers of patients could be ,102).
Early severe pain 0 –6
.............................................................. NRS ≤ 3
NRS > 3
Late severe pain 8– 24 h
.............................................................
P-value
NRS ≤ 3
NRS > 3
P-value
............................................................................................................................................................................... N¼
47
55
60
40
Age (years) Female gender (%)
65.6 + 11.4 10 (21%)
66.4 + 13.8 22 (40%)
0.746 0.042
65.8 + 10.4 16 (27%)
66.9 + 15.7 15 (38%)
0.67 0.251
BMI (kg/m2)
29.3 + 4.7
29.7 + 5.1
0.686
29.7 + 4.7
28.9 + 5.1
0.451
Diabetes mellitus 2 (%)
11 (23%)
11 (20%)
0.677
13 (22%)
9 (23%)
0.921
Chronic pain Intervention
5 (11%)
11 (20%)
0.195
6 (37.5%)
10 (62.5)
0.052
Ablation
19 (40%)
30 (55%)
0.155
32 (53%)
15 (38%)
0.120
28 (60%) 80.1 + 59.1
25 (45%) 105.5 + 64.9
0.043
28 (47%) 97.9 + 61.3
25 (62%) 86.2 + 65.9
0.364
Device surgery Duration (min)
BMI, body mass index; h, hours; min, minute; NRS, numeric rating scale.
well being and is, therefore, not only an important treatment quality measure, but also an ethical responsibility. † Conflict of interest: none declared. †
Appendix 1
†
Heart Center Leipzig policies According to the results presented here, pain management was adapted at our institution as follows: † The clinicians are advised to (i) pay a closer attention to the continuation of domestic pain medication, (ii) prescribe complete
†
recommended doses of painkillers, and (iii) inform patients on all given pain medications. Patients are now actively advised to disclose any pain they may experience. Nurses have been advised to ask patients about their pain intensity after interventions with the help of NRS every 2 h on the day of procedure. Analgesics are now offered to the patient at NRS . 3 or if the patient asks for it at a lower pain level. Due to the potential side effects of analgesics, the fact that pain resolved to low levels within the first 24 h in most of our patients, and the fact that 40% of our patients denied moderate-to-severe pain within the first 24 h, pain killers for acute post-interventional pain are prescribed on demand and not after a fixed time scheme.
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Table 3 Univariate analysis
Patient discomfort following catheter ablation and rhythm device surgery
† Oral non-opioid analgesics on demand are prescribed in the patient folder by doctors the evening before the intervention according the patient’s co-morbidities and laboratory results. On the day of the intervention, nurses are allowed to give this prescribed medication if pain is not caused by any other critical issues. Typical situations are back pain due to bed rest and pain at the device wound or groins due to incision or puncture. † Thirty to 60 min after the administration of pain killers, a reevaluation of pain has to be done by nurses and if NRS is still .3, doctors have to be informed and again have to exclude acute reasons for pain requiring further diagnostic and therapy. When indicated, patients are treated with opioids, such as subcutaneous Piritramid with continuous monitoring of vital signs. † A pain nurse attends to patients with chronic pain who are unresponsive to therapy. † Lastly, doctors and nurses are educated on acute and chronic pain management, pain evaluation, WHO guidelines, as well as medical and physical therapy options on a regular basis.
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