Original Paper

Urologia Internationalis

Received: July 15, 2013 Accepted after revision: February 3, 2014 Published online: May 17, 2014

Urol Int 2014;93:193–201 DOI: 10.1159/000360300

Impact of Thoracic Epidural Analgesia on Blood Loss in Radical Retropubic Prostatectomy Daniel Baumunk a Christof Maria Strang b Siegfried Kropf c Michael Schäfer d Mark Schrader g Steffen Weikert f Hannes Cash e Jan Breckwoldt d Kurt Miller e Thomas Hachenberg b Martin Schostak a Departments of a Urology and Paediatric Urology, b Anaesthesiology and Intensive Care Medicine and c Biometry and Medical Informatics, Magdeburg University Medical Centre, Magdeburg; Departments of d Anaesthesiology and Operative Intensive Care Medicine and e Urology, Charité-Universitätsmedizin Berlin, and f Department of Urology, Vivantes Humboldt Klinikum Berlin, Berlin; g Department of Urology, Ulm University Medical Centre, Ulm, Germany

Key Words Thoracic epidural analgesia · Radical retropubic prostatectomy · Blood loss · Prospective randomised clinical trial

Abstract Introduction: Radical retropubic prostatectomy (RRP) is associated with an increased risk of intraoperative blood loss and the necessity of transfusions. This prospective randomised clinical study evaluates the influence of thoracic epidural analgesia (TEA) on blood loss in RRP. Materials and Methods: 235 patients were randomised: TEA in group 1 (n = 116; general anaesthesia + TEA) comprised continuous administration of 0.25% bupivacaine, while group 2 (n = 119; general anaesthesia alone) received intravenous analgesia with fentanyl (intubation: 2 μg/kg; maintenance: 0.1– 0.3 mg). A restrictive infusion regimen (1 or an American Society of Anesthesiologists (ASA) score >2 according to the more common ASA classification [11]. Other exclusion criteria were idiopathic anaemia and/or haemorrhagic diathesis, any kind of previous prostate therapy and a second intervention during the same anaesthetic session. Applying these criteria, 235 patients were eligible for randomisation. All 235 patients could be analysed on an ‘intention-to-treat’ basis. Patients were randomised into two groups (group 1: n = 116; group 2: n = 119). GA was identical in both groups and comprised the following: premedication with midazolam (0.1 mg/kg), anaesthesia with thiopental 2–5 mg/kg, rocuronium (intubation dose

Baumunk  et al.  

Table 1. Patient characteristics and disease course

Age at surgery, years Height, cm Weight, kg Body mass index Preoperative Hb, mmol/l CCS score 0 (ASA = 1) 1 (ASA = 2) Serum creatinine, μmol/l Initial prostate-specific antigen, μg/l Preoperative Quick value, % Preoperative platelet count, Gpt/l Clinical stage Localised (number of patients) Locally advanced (number of patients) Biopsy Gleason score Hospitalisation, days Duration of operation, min Duration of catheterisation, days Specimen Gleason score Specimen volume, ml Positive margin in pT2, %

Group 1

Group 2

p value

62.5 ± 5.5 177.4 ± 18.9 88.6 ± 11.2 26.6 ± 3.2 9.37 ± 0.96

62.8 ± 4.7 177.2 ± 5.8 88.4 ± 11.8 26.7 ± 3.5 9.18 ± 1.1

0.48 0.99 0.18 0.19 0.10

87 (75.0%) 29 (25.0%) 85.8 ± 13.4 8.43 ± 5.8 99.2 ± 12.13 225.5 ± 70.6

101 (84.9%) 18 (15.1%) 86.7 ± 14.1 9.31 ± 9.36 97.4 ± 11.23 231.4 ± 49.2

85 28 6.53 ± 1.13 8.56 ± 3.32 174 ± 36.2 5.14 ± 3.3 6.79 ± 0.77 60.83 ± 19.1 5.74

88 23 6.38 ± 0.96 8.1 ± 4.01 180 ± 35.1 5.08 ± 3.04 6.79 ± 0.83 57 ± 17.35 5.55

0.09 0.52 0.39 0.24 0.46 0.52 0.54 0.76 0.12 0.74 0.99 0.12 0.67

Values are given as means ± standard deviations unless labelled differently.

0.5–0.6 mg/kg) or vecuronium (intubation dose 0.008–0.1 mg/kg), fentanyl (intubation dose 2 μg/kg), intubation followed by ventilation with isoflurane in a 50% oxygen-air mixture. The target minimal alveolar concentration of isoflurane was 1.0 in both groups. Isoflurane was used in this study primarily because of its marked vasodilator properties. Analgesia during the operative procedure was delivered to patients in group 1 by inserting a TEC at T11–T12. A bolus of 7.2 ± 0.9 ml bupivacaine (0.25%) was injected after insertion of the TEC in order to achieve analgesia between T7 and L3. 6.8 ± 0.7 ml/h bupivacaine (0.25%) was administered via a perfusor as maintenance dose. Implantation of a TEC has been shown to be a safe and effective procedure concerning intra- and postoperative pain management [12, 13] as well as reduction of perioperative stress response [14]. Patients in group 2 received peripheral intravenous analgesia with fentanyl 0.1–0.3 mg as maintenance dose. Intraoperative group differences in the intravenous analgesia requirements were not recorded. Present pain was documented on the first postoperative day using the Numeric Rating Scale (NRS, 0–10). In both groups a restrictive infusion regimen was defined of administering not more than 1,000 ml of any infusions, including colloids, from anaesthesia onset to removal of the specimen (operation phases A to C, see below). Furthermore, the use of colloid fluids should be avoided, but was not excluded throughout the operation. Four surgical phases were defined, and each phase was documented with regard to the type and quantity of fluid infused as well as circulatory parameters (e.g. MAP, heart rate, etc.): phase

A = from induction of anaesthesia to skin incision; phase B = skin incision and pelvic lymphadenectomy; phase C = from prostate resection to specimen removal; phase D = from specimen removal to termination of anaesthesia. The intraoperative haemodynamic target parameter of interest was the filling volume of the periprostatic venous plexus. Since invasive measuring techniques in the vessels of the periprostatic venous plexus were refused by the ethics committee because of a possibly increased risk of thromboembolic events, we had to rely on simple intraoperative parameters for the indirect control of the filling volume of the periprostatic venous plexus. Against this background, MAP seemed to be the best possible parameter to draw inferences about the sympathicolysis in the vessels of the periprostatic venous plexus. Therefore, the aim in both study groups was to reduce MAP to 60–70 mm Hg by the chosen form of anaesthesia, particularly in the decisive surgical phase C. All patients underwent traditional RRP using the technique described by Graefen and Huland [15] as well as pelvic lymphadenectomy [16] in a modified 25–30° Trendelenburg position. All operations were performed by three experienced surgeons (>250 RRP). The primary endpoint of the study was the intraoperative blood loss measured as the transfusion-adjusted difference between haemoglobin (Hb) levels preoperatively and 1 day after surgery. Overall blood loss as a secondary endpoint was determined as the sum of the aspirator volume and the difference in weight of abdominal swabs used intraoperatively. Another secondary endpoint was the intraoperative and postoperative transfusion rate. Intraoperatively

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8

p = 0.73

p = 0.19

transfusion-adjusted Hb difference (g/dl) between the pre- and the first postoperative day; p value calculated as Student’s t test. b Mean values ± standard deviations of overall blood loss (ml); p value calculated as Student’s t test.

a

4 3.35 2

0

Group 1

the anaesthesiologist determined whether intraoperative transfusion was indicated on the basis of clinical and vital parameters according to the guidelines of the German Medical Association: ECG changes, e.g. new ST segment changes, especially when combined with a Hb 0.05). Of these patients, 10 had positive surgical margins in localised disease (pT2) with no group differences (group 1: 5; group 2: 5; p > 0.05). Furthermore there were no group differences concerning the duration of hospitalisation (group 1: 8.56 ± 3.32 days; group 2: 8.1 ± 4.01 days; p = 0.76) or the duration of transurethral catheterisation (group 1: 5.14 ± 3.3

This prospective randomised clinical trial did not show any differences concerning intraoperative blood loss, overall blood loss or intra- and postoperative transfusion rates between the two groups, i.e. the implanta-

Anaesthetic Techniques in Radical Prostatectomy

Urol Int 2014;93:193–201 DOI: 10.1159/000360300

days; group 2: 5.08 ± 3.04 days; p = 0.74; table 1). Considering the patients of both groups, patients with CCS 0 had a measurable advantage over patients with CCS 1 with a 1.3 days shorter hospitalisation time (p = 0.037; not shown). No patient died within 3 months after surgery. Complications according to Clavien grades I and II occurred in 8 and 7 patients in group 1 and group 2, respectively, without group differences. Severe complications (Clavien grades IIIa–IVb) occurred in 5 patients (2 in group 1 and 3 in group 2), without group differences. Postoperatively, elevated serum creatinine levels were detected in 6 group 1 patients (5.1%) and 5 group 2 patients (4.2%), without group differences (92.07 vs. 87.51 μmol/l, p = 0.642). Only 1 of these patients (group 1; 0.8%) developed an acute renal failure >10 days. No group differences were observed concerning bowel disorders postoperatively. The postoperative pain level measured by the NRS on the first postoperative day was markedly lower in group 1 than in group 2 (NRS 1.91 [group 1] vs. 2.94 [group 2]; p < 0.001; fig. 3).

Discussion

197

Table 3. Regression analysis of factors potentially influencing blood loss in RRP

Parameter

Group Group 1 Group 2 Surgeon Surgeon 1 Surgeon 2 Surgeon 3 Age Weight CCS/ASA Preoperative creatinine Preoperative prostate-specific antigen Preoperative platelet count Preoperative clinical stage Preoperative Gleason score Specimen Gleason score Specimen weight Duration of operation Preoperative Hb

p value

Marginal mean* or regression coefficient b

95% Confidence interval lower bound

upper bound

3.620* 3.958*

3.192 3.559

4.048 4.357

3.779* 4.114* 3.474* 0.017 –0.036 0.258 –0.015 0.008 0.000 0.037 –0.169 0.037 0.000 0.009 0.623

3.455 3.350 3.007 –0.033 –0.066 –0.404 –0.035 –0.030 –0.005 –0.130 –0.452 –0.072 –0.016 0.002 0.330

4.102 4.879 3.941 0.068 –0.007 0.919 0.006 0.046 0.004 0.203 0.113 0.146 0.016 0.016 0.916

VIF

0.232 1.446

0.335

0.487 0.018 0.439 0.154 0.683 0.903 0.662 0.235 0.502 0.982 0.017 0.000

1.629 1.425 1.344 1.516 1.472 1.116 1.318 1.342 1.259 1.628 1.573 1.386 1.372 1.410

Dependent variable: Hb difference between the pre- and the first postoperative day. VIF = Variance inflation factor.

10

p < 0.001

Pain level

8 6 4 2 0

1.91

Group 1

2.94

Group 2

Fig. 3. Results of the NRS on the first postoperative day; p value calculated as Student’s t test.

tion of a TEC alone did not affect perioperative blood loss or perioperative transfusion rates in RRP. Intraoperative blood loss as well as overall blood loss were lower compared to those demonstrated in other series [2–6]. 198

Urol Int 2014;93:193–201 DOI: 10.1159/000360300

These observations conform to other series’ findings. In a prospective randomised study in 100 patients, Shir et al. [5] revealed that blood loss did not differ significantly between patients with combined epidural analgesia (EA)+GA and those with GA alone, but this study differed from ours in important variables: the groups had a considerably higher blood loss (1,490 and 1,940 ml/operation), and the achieved MAP (mean >80 mm Hg) was markedly above the values in our study. Additionally, the average infusion volume was >4,000 ml/patient and the average transfusion quantities were 950 and 960 ml/patient and operation. Barré et al. [20] examined 197 patients, mainly emphasising the patient’s position and the surgeon’s skills as favourable parameters with regard to blood loss in RRP. However, three study groups attributed a lower blood loss in RRP to perioperative EA: Dunet et al. [21] (retrospective, n = 62 patients), O’Connor et al. [22] (prospective, randomised, n = 102) and Tikuisis et al. [23] (prospective, n = 54). Limitations to these studies are the markedly smaller patient populations. Concerning different surgical procedures, the literature on prospective randomised trials comprising EA and its influence on blood loss is sparse. Eroglu et al. [24] Baumunk  et al.  

showed a decrease in blood loss and transfusion rates in 40 patients receiving hip replacement in favour of those patients (n = 20) who have received ‘hypotensive EA’ with bupivacaine. Recently, Wuethrich et al. [25] published the results of a prospective randomised clinical trial evaluating the effect of a restrictive fluid infusion regimen combined with continuous norepinephrine infusion in patients undergoing open radical cystectomy. The authors described a reduction in intraoperative blood loss and consecutively the need for blood transfusions in favour of those patients receiving a restrictive fluid infusion regimen combined with continuous norepinephrine infusion. The different anaesthetic strategies conducted in our study in order to achieve a reduction in the filling volume of the periprostatic venous plexus seemed to be effective in both groups, especially in the decisive surgical phase C. Lower MAPs were achieved in group 1. In group 2 the target MAP values between 60 and 70 mm Hg were only achieved in the decisive surgical phase C and not in the other surgical phases, which may be a strong limitation to our results. In terms of blood loss, however, the comparatively higher MAP did not turn out to be a disadvantage for group 2, since an effective MAP reduction 1,500 ml were avoided. However, since we failed to define a further infusion regimen after completion of surgical phase C, this circumstance may be a limitation to our findings. Summarizing these aspects of perioperative infusion management related to MAP reduction, it was an interesting observation that the combination of moderate hypotension (MAP: 60–70 mm Hg) with restrictive infusion of fluids appeared to positively influence blood loss in RRP regardless of the anaesthesiological procedure. However, the study was neither designed nor powered to assess the value of moderate hypotension or restrictive infusion therapy alone or in combination on the decrease in blood loss. Therefore, no conclusion can yet be drawn in this context. Overall, we could not find any disadvantages for the patients in group 1 concerning oncosurgical results or perioperative parameters such as duration of the operation, duration of hospitalisation or duration of transurethral catheterisation due to TEA; for instance, the implantation of a TEC did not affect surgical feasibility or effectiveness. Factors that could potentially influence blood loss in the present patient population were analysed using a multiple regression model. In our study population higher body weight was negatively correlated with the Hb difference between the pre- and the first postoperative day. As an explanation for this correlation, there may be an effect of the increased overall blood volume in obese patients which might have led to a lower Hb difference. The preoperative Hb levels as well as the duration of the operation had a positive correlation with the Hb difference between the pre- and the first postoperative day, which seems to be a consistent observation. However, since other factors with a potential influence on blood loss were omitted in our analysis (e.g. prothrombin time or fibrinogen concentrations), this circumstance may be a limitation to our findings. On the whole, the anaesthetic strategies, especially deliberate hypotension, did not increase the rate of severe complications in either group compared to similar populations [29–31]. A reduced blood loss in RRP is believed to have a direct impact on patients’ outcomes and a decrease in bleeding- and transfusion-related side effects, and may lead to faster recovery and shorter hospitalisation. In general, use of TEA during surgical interventions may have a favourable impact on postoperative outcome in terms of morbidity and postoperative bowel function [9]. Gupta et al. [32] were able to show a reduction in postoperative mortality after rectal surgery in favour of

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those patients who received epidural anaesthesia and analgesia. In RRP patients TEA may provide better perioperative analgesia at lower doses, lower perioperative morbidity, shorter hospitalisation, fewer cardiovascular side effects, improved ventilation and oxygenation, less nausea and vomiting, faster mobilization, faster recovery of postoperative bowel function and higher patient satisfaction [31–36]. Concerning present pain, we found group differences in favour of group 1 on the first postoperative day. However, this observation has strong limitations because of undetermined postoperative analgesia regimens in the study protocol. Present pain, pain relief and patients’ satisfaction were no endpoints of our study and therefore the study was not powered to assess the impact of TEA on perioperative pain. In comprehensive reviews, Bonnet and Marret [37] as well as Kettner et al. [38] confirmed a substantial impact of EA on improvement of perioperative pain management. However, a direct impact on a decrease in postoperative mortality remains unclear. Interestingly, epidural anaesthesia was found to be associated with a reduced risk of prostate-specific antigen relapse [39]. This may possibly be due to lower blood loss and thus lower risk of local tumour cell proliferation. This theory is supported by Oefelein et al. [40], who were able to demonstrate a significant correlation between intraoperative blood loss and relapse-free survival, as well as by Lloyd et al. [41] in an analysis of the SEARCH database.

Changes in operation techniques have led to a measurable blood loss reduction in radical prostatectomy. Laparoscopic radical prostatectomy and robot-assisted radical prostatectomy have shown a decrease in blood loss and transfusions as compared to RRP in large meta-analyses [42, 43]. However, currently there are no data available showing an advantage of laparoscopic radical prostatectomy and robot-assisted radical prostatectomy over RRP concerning oncological outcomes, complication rates or functional outcomes in comparative prospective randomised trials.

Conclusions

This prospective randomised clinical trial did not show a direct impact of TEA on blood loss and transfusion rates in RRP. Blood loss in RRP seems to be the result of multifactorial influences. There may be a positive impact of the anaesthetic procedures conducted (deliberate hypotension, patient’s position and restrictive infusion therapy) alone or in combination on blood loss and transfusion rates in RRP. However, the findings of the present study do not allow conclusions in this context. Further prospective randomised clinical trials are needed to substantiate the impact of the different anaesthetic procedures on blood loss in RRP. TEA may provide sufficient perioperative pain management and was not associated with disadvantages concerning oncological efficiency or perioperative outcomes in RRP patients.

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Impact of thoracic epidural analgesia on blood loss in radical retropubic prostatectomy.

Radical retropubic prostatectomy (RRP) is associated with an increased risk of intraoperative blood loss and the necessity of transfusions. This prosp...
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