Eur J Orthop Surg Traumatol DOI 10.1007/s00590-014-1483-3

ORIGINAL ARTICLE

Interscalene plexus block versus general anaesthesia for shoulder surgery: a randomized controlled study Lars J. Lehmann • Gregor Loosen • Christel Weiss • Marc D. Schmittner

Received: 17 January 2014 / Accepted: 5 May 2014 Ó Springer-Verlag France 2014

Abstract Objectives This randomized clinical trial evaluates interscalene brachial plexus block (ISB), general anaesthesia (GA) and the combination of both anaesthetic methods (GA ? ISB) in patients undergoing shoulder arthroscopy. Methods From July 2011 until May 2012, 120 patients (male/female), aged 20–80 years, were allocated randomly to receive ISB (10 ml mepivacaine 1 % and 20 ml ropivacaine 0.375 %), GA (propofol, sunfentanil, desflurane) or ISB ? GA. The primary outcome variable was opioid consumption at the day of surgery. Anaesthesia times were analysed as secondary endpoints. Results After surgery, 27 of 40 patients with a single ISB bypassed the recovery room (p \ 0.0001). Postoperative monitoring time was significantly shorter with single ISB compared with both other groups [GA: 93 (5–182) min vs. GA ? ISB: 57.5 (11–220) min vs. ISB: 35 (5–106) min, p \ 0.0001]. Opioid consumption was reduced using a single ISB at the day of surgery [GA: n = 25 vs. GA ? ISB: n = 10 vs. ISB: n = 10, p = 0.0037].

L. J. Lehmann (&) Department of Orthopedic and Trauma Surgery, Orthopaedic and Trauma Surgery Centre, University Medical Centre Mannheim, Theodor-Kutzer-Ufer 1-3, 68187 Mannheim, Germany e-mail: [email protected]; [email protected] G. Loosen  M. D. Schmittner Department of Anaesthesiology and Surgical Intensive Care Medicine, University Medical Centre Mannheim, TheodorKutzer-Ufer 1-3, 68187 Mannheim, Germany C. Weiss Department of Medical Statistics, University Medical Centre Mannheim, Ludolf- Krehl-Str. 13-17, 68167 Mannheim, Germany

Conclusion ISB is superior to GA and GA ? ISB in patients undergoing shoulder arthroscopy in terms of faster recovery and analgesics consumption. Keywords Shoulder arthroscopy  Regional anaesthesia  Interscalene brachial plexus block  Ultrasound  General anaesthesia

Introduction During the last decade, the incidence of arthroscopic shoulder surgery rose significantly [1]. The beach chair position, a variation of the sitting position for shoulder arthroscopy, has been widely accepted among orthopaedic surgeons [2]. For this purpose, a suitable anaesthesia technique is necessary which is safe, easy to perform and leads to a high patient satisfaction. First described in 1970 by Winnie, interscalene brachial plexus block (ISB) is nowadays a well-established treatment, which can be used alone or combined with GA [3]. Compared with GA, several authors describe advantages of the ISB in terms of patient satisfaction in retrospective analysis [4, 5]. In a clinical routine, ISBs are often combined with a GA to receive the advantages of both techniques. On the other hand, anaesthesia-related times gain and potential side effects of both techniques may rise. A reduction of opioids, caused by an ISB, may also decrease the incidence for postoperative nausea and vomiting (PONV) which is a common and sometimes severe adverse outcome for ambulatory patients [6]. Although, there are several options for anaesthesia during shoulder surgery and while there are purported advantages to each, the comparative analgesic efficacy is unclear. Therefore, this study’s hypothesis was to determine postoperative

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analgesics demand and recovery times in patients undergoing shoulder arthroscopy in ultrasound-guided ISB, GA and the combination of both methods.

Materials and methods We performed this single-centre randomized clinical trial after approval of our local ethics commission (Medical Ethics Commission II, Maybachstr. 14, 68169 Mannheim, Germany, protocol number: 2010-335N-MA, 27.01.2011) and the international registration (http://www.controlledtrials.com, Registration number: ISRCTN84074316) at the University Medical Centre Mannheim. Between July 2011 and May 2012, all patients aged 20–80 years with American Society of Anaesthesiologists (ASA) grade I–III undergoing shoulder arthroscopy were eligible for the study. Exclusion criteria were contraindications to ISB or GA, ASA grade IV–VI and allergy to diclofenac, paracetamol or metamizole. Opioid consumption at the day of surgery was the main outcome variable. By our own experience, we estimated a rate of approximately 60 % of all patients with a GA receiving opioids in the postoperative period. We felt that a reduction to a maximum opioid consumption rate of 30 % in the ISB group would be clinically relevant. Thus, assuming proportions of 0.65 and 0.30, we computed thirty-one as an appropriate sample size for each group by using the SAS procedure PROC POWER (with a power of 0.80 and alpha = 0.05). Because these proportions are not exactly verified and because of the large number of patients treated in our hospital, we planned 40 patients in each group. In order to get a balanced design, we also involved 40 patients in the GA ? ISB group as well. Thus, a total number of 120 patients participated in our study. Anaesthesia times and patient satisfaction were analysed as secondary end points. Verbal and written information was given to all eligible patients before informed written consent was obtained. Patients received 7.5 mg midazolam (DormicumÒ; Roche Pharma, Grenzach-Wyhlen, Germany) for oral premedication. Electrocardiography, blood pressure and oxygen saturation were monitored at 5-min interval throughout the operation. Perioperative anaesthesia-related side effects were recorded by a study nurse. Patients were randomized by drawing a lot out of two blocks, 60 sealed envelopes for every single patient directly before the scheduled operation. Ultrasound-guided interscalene brachial plexus block (ISB) The block was performed as per a previously described technique using a 5 cm, 10–12 MHz linear probe (LOGIQ

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eÒ, GE Healthcare, Munich, Germany) [7]. Via a 22-G, 50-mm short-bevel needle (StimuplexÒ D, B. Braun, Melsungen, Germany), with an out-of-plane approach, the nerve trunks were surrounded by 10 ml mepivacaine 1 % and 20 ml ropivacaine 0.375 % (10 ml NaCl ? 10 ml NaropinÒ 7.5 mg/ml, AstraZeneca, Wedel, Germany) with intermittently aspiration to rule out intravascular location. A study nurse recorded the time of block performance, defined as time from insertion until extraction of the needle of the skin. We determined the expansion of the sensory block 10 min after needle removal by cold–warm discrimination using ice. The block was evaluated as ‘‘suitable for surgery’’ when dermatoma C4–C6 were anaesthetized. The study protocol permitted the weight-adapted use of sufentanil (Sufenta mite 10Ò; Janssen-Cilag, Neuss, Germany) in the event of occurring pain. In the case of block failure during surgery, defined as the inability to carry out the procedure without an airway device, GA was administered, and the block was recorded as ‘‘failed’’. For patients receiving ISB as the sole technique, optionally propofol 10 mg/ml (PropofolÒ, Fresenius Kabi, Bad Homburg, Germany) was injected as a bolus application until a light level of sedation was reached—an Observer’s Assessment of Alertness/Sedation score of 4–5 [8]. Oxygen was applied at a flow rate of 8 l/min via an oxygen mask. General anaesthesia (GA) GA was induced with 2 lg/kg sufentanil, and 2.5 mg/kg propofol was administered intravenously. The anaesthesiologist was allowed to increase the dose of sufentanil intraoperatively when necessary. All patients received a laryngeal mask (AuraOnceÒ, Ambu, Bad Nauheim, Germany) seize 4 or 5. Anaesthesia was maintained with desflurane (SupraneÒ, Baxter, Unterschleissheim, Germany) with an age-adapted minimal alveolar concentration (MAC) of 5–7 volume %. Volume-controlled ventilation was performed with a tidal volume of 6–8 ml/kg to receive normo-ventilation. Correct position was defined as sufficient ventilation without any oesophageal or laryngeal leak. In case of an occurring leak, the study protocol permitted the change of the airway device to a tracheal tube. Operative procedures All operations were performed in the beach chair position. The remaining surgical procedures were divided into three subgroups: rotator cuff repair (arthroscopically or mini open repair-technique), subacromial procedures like subacromial decompression, AC joint resection and glenohumeral procedures like arthroscopic stabilisation, biceps tenotomy/tenodesis and SLAP repair.

Eur J Orthop Surg Traumatol

Analgesic consumption All patients received routinely diclofenac twice a day (75 mg at 08:00 hours and at 20:00 hours) and paracetamol three times a day (500 mg at 08:00 hours, 12:00 hours and 20:00 hours each) per os. Additional analgesics were administered intravenously as needed according to a pain step protocol, using an 11-point numeral rating scale (NRS; 0, no pain; 10, worst pain imaginable): step 0: NRS 0–2: no further analgesics, step 1: NRS 3–4: 1,000 mg paracetamol (PerfalganÒ 10 mg/ml, Bristol-Meyrs Squibb, Munich, Germany) or 1,000 mg metamizole (Novaminsulfon-ratiopharmÒ, Ulm, Germany) depending on the individual belongings of the patients, step 2: NRS 5–6: 1,000 mg paracetamol and 1,000 mg metamizole and step 3: NRS 7–10: 1,000 mg paracetamol and 1,000 mg metamizole and 7.5 mg piritramide (Piritramid-hamelnÒ, Hameln, Germany, the dosage of piritramide could be increased until a pain on the NRS of\3 could be reached). Analgesic consumption was measured in the recovery room and then daily at 08:00 am until patients were discharged from hospital. Anaesthesia times and recovery According to the ‘‘Perioperative Procedural Time Glossary’’ established by the German Society of Anaesthesia and Intensive Care, a study nurse recorded the anaesthesia and surgery-related times [9]. After leaving the operation theatre, all patients were monitored in the recovery room until they attained an Aldrete score of at least 10 points and had full recovery from sedation [10]. Patients with a single ISB were able to bypass the recovery room when they met the same criteria as mentioned above. Patient satisfaction Patient satisfaction was evaluated with the help of a standard questionnaire based on the validated German translation of the nine-point Quality of Recovery (QoR—9) which had to be completed within 48 h of the operation, before discharge [11]. Patients were asked to classify the anaesthesia method ‘‘better than’’, ‘‘same as’’ or ‘‘worse than expected’’ and give a grade on an 11-point analogue scale (0 = worst, 10 = best grade).

respectively. For skewed variables, Kruskal–Wallis tests or Mann–Whitney U tests were performed instead. For the comparison of qualitative parameters, chi-squared tests or Fisher’s exact tests have been applied. Logistic regression was performed as a multivariable model in order to analyse two factors for a binary outcome simultaneously. For ordinal-scaled data, Cochran–Mantel–Haenszel tests or Cochran–Armitage trend tests have been used in order to test whether mean scores differ among three or two groups, respectively. All statistical calculations were done with the SAS software, release 9.2 (SAS Institute Inc., Cary, NC, USA). Statistical significance has been assumed for p values less than 0.05.

Results Over the study interval, 167 patients underwent shoulder arthroscopy, of which 120 were randomized to either a GA (40 patients), or an ISB (40 patients) or the combination of GA and ISB (40 patients). Demographic data, analgesic consumption and postoperative recovery were evaluated for all 120 patients. Thirty-five patients with a GA, 37 with an ISB and 36 with GA and ISB completed the questionnaire. There were no significant differences in terms of demographic data neither between the three study groups (Table 1) nor between the 108 patients who completed the questionnaire and those 11 who did not. General aspects No life-threatening complication occurred in either group. Eighty patients received an ISB (ISB: n = 40, GA ? ISB: n = 40). One block failed in the ISB group and resulted in a GA. Seven of 40 patients with ISB were supplemented with 10 (5–30) lg sufentanil where after the operative procedure could be continued. Twenty of 40 patients received additional sedation. Two patients in the group GA ? ISB developed a paresis of the N. laryngeus recurrens, which fully recovered the day after surgery. Patients with a GA received more propofol [200 (120–330)] mg compared with the group GA ? ISB (150 (100–250) mg, p = 0.0037) and more sufentanil (GA: 40 (20–70) lg; GA ? ISB: 25 (20–50) lg, p \ 0.0001). Ventilation with the laryngeal mask was insufficient in 14 of 80 patients (GA: n = 9, GA ? ISB: n = 5) and resulted in tracheal intubation.

Statistical methods Analgesic consumption Quantitative variables are presented by mean values ± standard deviation or median together with the range. For approximately normally distributed data, oneway ANOVAs or 2 sample t tests have been used in order to compare the mean values of three or two groups,

ISB and GA ? ISB led to a reduction of opioids compared with GA only at the day of surgery. No further reduction of analgesics was achieved when patients received an additional GA compared with ISB alone (Table 2).

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Eur J Orthop Surg Traumatol Table 1 Demographic data of patients receiving general anaesthesia (GA), general anaesthesia and interscalene brachial plexus block (GA ? ISB) and interscalene brachial plexus block (ISB) GA general anaesthesia, ISB interscalene block, BMI body mass index, ASA American Society of Anaesthesiologists grade * Values are mean ± s.d

GA (n = 40)

ISB (n = 40)

p

Sex (m:f)

22:18

18:22

27:13

0.1273

Age (years)*

54.1 ± 11.7

53.8 ± 15.2

49.3 ± 13.6

0.2251

Body height (cm)*

172.6 ± 10.7

169 ± 9.8

172.2 ± 9.9

0.2615 0.2285

Body weight (kg)*

83.3 ± 16.6

81.5 ± 16.3

88.2 ± 19.2

BMI (kg/m2)*

27.9 ± 4.7

28.6 ± 5.2

29.6 ± 5.4

0.3531

ASA (1:2:3)*

13:25:2

22:16:2

19:21:0

0.1426

Subacromial procedure: rotator cuff repair : glenohumeroidal repair

22:15:3

13:17:10

12:21:7

0.0711

Patient satisfaction

Table 2 Analgesic consumption Day after surgery

GA (step 0:1:2:3)

GA ? ISB (step 0:1:2:3)

ISB (step 0:1:2:3)

P value

0 (day of surgery)

8:6:1:25

18:7:5:10

15:8:7:10

CMH: p = 0.0037 GA versus GA ? ISB p = 0.0024 GA versus ISB p = 0.0072 GA ? ISB versus ISB p = 0.6487

1

27:5:1:7

19:11:0:10

20:10:2:8

CMH: p = 0.4393

2

34:2:0:4

29:2:1:8

30:7:0:3

CMH: p = 0.2470

3

35:2:1:2

34:1:0:5

37:2:0:1

CMH: p = 0.2904

4

37:1:0:2

35:1:0:4

38:1:0:1

CMH: p = 0.3603

P values have been obtained by Cochran–Mantel–Haenszel tests (CMH) or Cochran–Armitage trend tests for pairwise comparisons. All patients received routinely diclofenac twice a day (75 mg at 08:00 h and at 20:00 h) and paracetamol three times a day (500 mg at 08:00 h, 12:00 h and 20:00 h each) per os. Additional analgesics were administered intravenously as needed according to a pain step protocol, using an 11-point numeral rating scale (NRS; 0, no pain; 10, worst pain imaginable)

Anaesthesia times and recovery There was no difference concerning the surgical procedure times between the groups. GA led to the shortest times for anaesthesia induction and anaesthesia presence. Twentyseven of 40 patients with an ISB only bypassed the recovery room (p \ 0.0001). Single ISB lead to the shortest monitoring times in the recovery room, as well as to shortest times until first ambulation and food intake and the longest times until the occurrence of pain (Table 3).

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GA ? ISB (n = 40)

All patients gave very good grades independently from the anaesthetic method offered. ISB led to significantly better grades (0 = worst, 10 = best grade) compared with GA [GA: 9 (0–10) versus GA ? ISB: 9 (3–10) versus ISB: 10 (4–10), p = 0.0134]. ISB was also rated more often ‘‘better than expected’’ (vs. ‘‘same as expected’’/‘‘worse than expected’’) compared with other anaesthetic techniques: GA: 12/16/7 vs. GA ? ISB: 21/11/4 vs. ISB: 28/7/2, p = 0.0031. Table 4 shows the ratings of the QoR—9 score.

Discussion The rising incidence of arthroscopic shoulder surgery necessitates an anaesthesia technique which is safe, provides a long lasting analgesia and leads to a fast recovery and a high patient acceptance. ISB is considered to be superior compared with subacromial bursa block or intraarticular injection where serious complications like chondrolysis were reported [12–14]. But it can also lead to acute and nonacute complications [15]. One limit of our study can be mentioned in the choice of local anaesthetics and the volume applied. In a prospective study, Fredrickson et al. determined the optimal volume and concentration for the use of ropivacaine in shoulder surgery. They found 20 ml ropivacaine 0.375 % to provide equivalent analgesia, but better patient satisfaction than traditional dose of 30 ml ropivacaine 0.5 % [16]. Riazi et al. [17] compared the effect of local anaesthetic volume of 20 versus 5 ml in ultrasound-guided ISB and concluded that the use of 5 ml was associated with fewer respiratory and other complications with no change in postoperative analgesia compared with 20 ml. On the other hand, Gautier et al. surveyed the minimum effective anaesthetic volume of 0.75 % ropivacaine in ultrasound-guided ISB and found successful blocks with 5 ml of local anaesthetics, but a

Eur J Orthop Surg Traumatol Table 3 Times concerning postoperative recovery presented with median and range

GA (n = 40)

Anaesthesia induction time (min)

9.5 (2–20)

31 (16–93)

17.5 (10–66)

KW: p \ 0.0001

112.5 (65–209)

120 (85–224)

133.5 (80–215)

KW: p = 0.0008

57.5 (11–220)

35 (5–106)*

KW: p \ 0.0001

* Recovery room time was evaluated only for patients monitored there (n = 13 for ISB group)

93 (5–182)

49 (27–134)

p values

49 (22–110)

Recovery room time (min)

46.5 (20–132)

ISB (n = 40)

Surgical procedure time (min)

Anaesthesia presence time (min)

Kruskal–Wallis tests (KW) and Mann–Whitney U tests have been used in order to compare 3 or 2 groups

GA ? ISB (n = 40)

KW: p = 0.8059

Time from complete closure until first occurence of pain (min)

214 (31–1029)

413 (60–1176)

475 (53–1311)

KW: p = 0.0012

Time from complete closure until first ambulation (min)

272 (75–1231)

195 (85–500)

85 (11–1156)

KW: p \ 0.0001

Time from complete closure until first food intake (min)

324 (95–1159)

225 (85–480)

66 (11–968)

KW: p \ 0.0001

Table 4 Subjective perceptions measured by the QoR—9 score GA (n = 36)

GA ? ISB (n = 36)

ISB (n = 37)

p

Felt well most of the time

21/5/8

27/8/2

29/8/0

0.0283

Needed help from nurse or anaesthetist

24/9/1

19/13/4

25/11/1

0.1327

Could understand orders and explanations

30/5/0

37/0/0

36/1/0

0.0199

Could care for self after surgery

21/10/4

30/5/2

28/9/0

0.0735

Could go to the toilet alone

32/3/0

32/4/1

35/2/0

0.3548

No problems with breathing

31/2/2

31/5/1

32/5/0

0.8658

Muscle and back pain

7/11/17

11/5/20

2/5/29

0.0115

Nausea and vomiting

10/9/16

4/8/24

2/3/31

0.0015

Intermittent strong pain

11/15/9

10/13/13

3/15/19

0.0192

GA general anaesthesia, ISB interscalene block (yes/partially/no)

possibility of 25 % failure rate [18]. Gadsden et al. [19] tested the effect of mixing 1.5 % mepivacaine and 0.5 % bupivacaine for ultrasound-guided ISB and found a block onset similar to either local anaesthetic alone, but the mean duration of blockade significantly shorter than with bupivacaine alone. Nevertheless, we chose to add 10 ml mepivacaine 1 % to the recommended dose for a supposed faster onset of the block. This modified dosage could be responsible the intermittent paresis of the N. laryngeus recurrens in two patients. In retrospective articles, ISB success rates were reported to be 84–96 % [4, 20]. Both

authors conducted the blocks with a nerve stimulator technique. The higher success rate of 97.5 % in our study may be explained by the use of ultrasound. Analgesic demand was the primary outcome variable of our study. There was a significant reduction of opioid consumption in patients receiving ISB and GA ? ISB compared with GA in the recovery room and at the day of surgery that can be explained by the long duration of the local anaesthetics compared with sufentanil. Although ISB can achieve sufficient regional anaesthesia, in the daily routine a combination with GA is mostly performed either to cover block failures or to satisfy patients’ wish for sedation. Opioid agonists evoke emesis and are a risk factor for nausea and vomiting in the late postoperative period [21]. In this study, ISB reduced the amount of sufentanil for induction of anaesthesia and consecutively the incidence of PONV. Other than in retrospective studies, we used a laryngeal mask airway instead of tracheal intubation [4, 20]. A 1995 metaanalysis of 858 publications identified several advantages of a laryngeal mask over tracheal intubation [22]. Nevertheless, supraglottic airway devices do have disadvantages, like a minor protection from pulmonary aspiration of gastric contents or a potential air leakage [23]. In our study, 14/80 patients (17.5 %) received a tracheal intubation due to insufficient ventilation in beach chair position. This rate is significantly higher compared with data from Ramachandran et al. [24] who studied 15.795 patients with a laryngeal mask and found a low failure rate of only 1.1 %. We explain this higher incidence with the beach chair position where the laryngeal mask does not seal up the upper airway sufficiently with the head reclined. Although additional time is required to perform the block compared with GA, the overall anaesthesia-

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related workflow can be improved and the total costs can be reduced as Gonano et al. [25] surveyed in a prospective study with 40 patients. Evaluation of patient satisfaction with the overall perioperative care process is an integral part of modern quality management. Unfortunately, there is currently no method established in Germany that can be recommended for a quality assurance programme [26]. The high satisfaction of all three groups reflects the fact that patients are satisfied with the anaesthesia method offered to them [27]. More patients with ISB evaluated the method ‘‘better than expected’’, indicating that there are still negative associations with regional anaesthesia [28].

9.

10. 11.

12.

13.

14.

Conclusion ISB is superior to GA and GA ? ISB in patients undergoing shoulder arthroscopy in terms of faster recovery and patient satisfaction. Acknowledgments The study was funded by the University Medical Centre Mannheim. Conflict of interest interest.

15.

16.

17.

None of the authors declares a conflict of 18.

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Interscalene plexus block versus general anaesthesia for shoulder surgery: a randomized controlled study.

This randomized clinical trial evaluates interscalene brachial plexus block (ISB), general anaesthesia (GA) and the combination of both anaesthetic me...
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