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From the Department of Anesthesia, University Hospital Hamburg-Eppendorf, Hamburg, Germany.
Address correspondence to: Dr. Marc A. Burmeister, Department of Anesthesia, University Hospital Eppendorf, Martinistrasse 52, D-20246 Hamburg, Germany. Phone: +49-40-42803-2415/4525; Fax: +49-40-42803-4963; E-mail: burmeister{at}uke.uni-hamburg.de
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Abstract |
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Methods: The present prospective, randomized, double-blind study was performed to investigate the effects of intra- and postoperative TEA vs only postoperative TEA using ropivacaine 0.375% in 30 women scheduled for major abdominal tumour surgery. Prior to induction of general anesthesia patients received an epidural bolus of 10 mL saline in Group I (GI) and 10 mL ropivacaine 0.375% in Group II (GII) followed by an infusion of 6 mL•hr-1 of the respective solution during surgery. Postoperatively all patients received an epidural infusion of 6 mL•hr-1 ropivacaine 0.375% during 24 hr followed by patient controlled epidural analgesia for the next 72 hr. Operative data, dynamic pain scores, consumption of local anesthetics and standardized supplemental analgesics were analyzed.
Results: No difference was seen between groups with respect to the amount of required postoperative local anesthetics and supplemental analgesics, pain scores and side effects during the first 96 hr following surgery except a reduction of intraoperative sufentanil consumption (GI: 143.2 ± 52.6 vs GII: 73.3 ± 32.6 µg, P < 0.001).
Conclusion: Intraoperative TEA with ropivacaine 0.375% did not significantly reduce the amount of analgesics required after major abdominal gynecological tumour surgery.
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Introduction |
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Methods |
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On the day of surgery patients were premedicated orally with 7.5 mg midazolam (Hofmann-La Roche, Grenzach-Wyhlen, Germany) 60 min before arriving in the anesthesia room where they were monitored by an electrocardiogram (ECG), noninvasive measurement of blood pressure and pulse oximetry. Following the iv infusion of 500 mL of Ringer’s solution a thoracic epidural catheter was placed before general anesthesia was induced.
All patients were awake during insertion and testing of the epidural catheter. With the patient in the sitting position, a deep skin infiltration with 3–5 mL lidocaine 1% (AstraZeneca, Wedel, Germany) was performed for local anesthesia before the 18-G Tuohy needle (B. Braun, Melsungen, Germany) was inserted at the T8 ± 1 level. After the loss of resistance had been obtained, a 22-G end-hole catheter (B. Braun) was inserted 4 cm into the epidural space. A test dose of 3 mL plain mepivacaine 2% (AstraZeneca) was injected after negative aspiration. All catheters were tunnelled subcutaneously 5 cm to the right or left side and secured with a single stitch at the skin outlet. Five minutes later, patients were randomly allocated to receive 10 mL NaCl 0.9% in Group I (GI) or 10 mL ropivacaine 0.375% (AstraZeneca) in Group II (GII) using a computer-generated random list (MS Excel, Microsoft Inc., Redmond, WA, USA) via the epidural catheter. Patients and investigators were blinded to study groups. Twenty minutes after the epidural injection, general anesthesia was induced with 0.4 µg•kg-1 sufentanil and 0.25 g•kg-1 etomidate lipuro iv (B. Braun). To facilitate orotracheal intubation, cisatracurium 0.15 mg•kg-1 (GlaxoSmithKline, Bad Oldesloe, Germany) was given. A central venous catheter was inserted via the external or internal jugular vein. Anesthesia was maintained with isoflurane (0.5 vol%, end-tidal) in nitrous oxide and 30% oxygen. Patients received repetitive boli of sufentanil for analgesia depending on predefined clinical criteria (tachycardia > 90 beats•min-1 and mean arterial pressure (MAP) > 90 mmHg if hypovolemia was excluded by central venous pressure > 5 mmHg measurement). Until incision no additional sufentanil was given in both groups.
The first injection was immediately followed by a continuous epidural infusion of 6 mL•hr-1 of the respective study medication until the end of surgery. After completion of surgery (end of skin closure) patients of both groups received a continuous epidural infusion of 6 mL•hr-1 ropivacaine 0.375% and were transferred to the intensive care unit (ICU), where mechanical ventilation was discontinued after a stabilization period until patients reached predefined extubation criteria (body temperature 36.5–38.0°C, MAP > 60 mmHg without vasoconstrictors, PaO2 > 80 mmHg with 30% oxygen, no surgical bleeding). Twenty-four hours after the start of the epidural infusion, pain management was changed from continuous to patient controlled epidural analgesia (PCEA) with ropivacaine 0.375% in both groups using the Graseby 9300 infusion pump (SIMS, Graseby Ltd, Watford, UK). The basal infusion rate was 4 mL•hr-1 with a bolus of 2 mL and a lock-out interval of 15 min. During the entire postoperative observation period patients were allowed to receive piritramide iv as a supplemental analgesic (15 mg piritramide are equivalent to 10 mg morphine), if pain at rest was > 40 mm on the VAS and the allowed bolus of 2 mL ropivacaine 0.375% was not able to control pain within 15 min.
The quality of analgesia was assessed by an anesthesiologist blinded to the group assignments at rest and during mobilization (sitting on the bedside) 24, 48, 72 and 96 hr after the start of the epidural infusion using a VAS. Intensity of motor block (Bromage scale 0–3), upper and lower level of analgesia (pinprick test), side effects (nausea, vomiting, pruritus, shivering, bladder dysfunction), cumulative amount of infused study solutions, demanded and received PCEA-boli, and cumulative supplemental piritramide requirements were recorded. Patients were asked and examined for complications or side effects associated with epidural anesthesia such as persisting motor block, bladder dysfunction, postdural puncture headache and radicular irritation up to the seventh postoperative day. Intraoperative blood and fluid losses and requirements were recorded.
Sample size calculation and statistical analysis
Sample size was calculated on the basis of retrospective data from our institution in the same surgical population. A power analysis was performed by using the cumulative consumption of administered study solution over four days as the primary outcome variable. We set 6 mL•hr-1 as the mean dose of epidurally required analgesic. This translates into a cumulative dose of 576 mL over the whole study period of 96 hr. For calculation of the sample size, we decided the smallest difference to be clinically significant was 25% (144 mL) of the cumulative amount of epidural analgesics over four days. The anticipated pooled standard deviation was set at 100 mL of the cumulative dose. We would permit a type I error of 
= 0.05, and with the alternate hypothesis, the null hypothesis would be retained with a type II error of ß = 0.05. This analysis reaches a power of 0.95 and indicated that a sample size of at least 14 patients per group was necessary.
Computerized statistical analysis was performed using SPSS 9.0 (SPSS Inc., Chicago, IL, USA) and Instat 2.1 (Graphpad Inc., San Diego, CA, USA). Data are given as mean ± SD unless otherwise indicated. Demographic and perioperative data including hemodynamics and volume of epidural infusion were tested using unpaired Student’s t test. Statistical methods included Mann Whitney U test for VAS values, upper and lower level of epidural block and piritramide requirements. Chi square testing was used for side effects and intensity of motor block. P < 0.05 was considered significant.
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As shown in the Table
patients did not differ in demographic characteristics such as age, height, weight and ASA status. Duration of surgery, intraoperative blood loss, amount of transfused red blood cells and fresh frozen plasma, duration of stay in the ICU and total in-hospital stay was similar in both groups. The cumulative intraoperative dose of sufentanil was significantly higher in GI when compared with GII. No difference was observed in duration of postoperative mechanical ventilation. Details of the perioperative data are shown in the Table. Heart rate decreased after induction of anesthesia in both groups and was lower in GII at the end of surgery only (Figure 1a). The mean arterial blood pressure decreased in both groups after induction of general anesthesia and was significantly lower in GII vs GI at the time of surgical incision but comparable during the rest of surgery (Figure 1b).
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. There was no significant difference between the two groups at rest or during mobilization. The cumulative volume of the epidurally required ropivacaine was nearly identical in both groups and below the maximal possible volume (Figure 3). The cumulative dose of piritramide is also shown in Figure 3. Although there seems to be a trend towards a higher consumption in GII, the difference was not significant (P = 0.24 at the end of the observation period). Approximately half of the patients in each group demanded supplemental piritramide. Upper and lower levels of sensory block did not differ between groups during the entire observation period (range of upper/lower levels at 24 hr, GI: T4–8/L1–L3; GII: T5–7/T12–L2; at 48 hr, GI: T6–9/T12–L2; GII: T5–9/T11–L1; at 72 hr, G1: T6–9/T12–L1; GII: T6–9/T11–L2; at 96 hr, GI: T6–9/T12–L2; GII: T7–9/T11–L1).
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Discussion |
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As already mentioned, the preemptive analgesic effect appears to be dependent on the type of surgery. The preemptive analgesic effect of epidurally administered local anesthetics in abdominal gynecological surgery remains unclear. Our results are in accordance with the findings of Aida et al., who also found no preemptive effect of pre-surgical epidural analgesia in abdominal surgery using morphine. One main reason for the ineffectiveness of epidural analgesia in viscero-peritoneal surgery could be the heterosegmental innervation of the operated area, e.g., sensory innervation by the phrenic nerve, since epidural analgesia is only able to block the segmental innervation by spinal nerves. This problem seems to occur especially in upper abdominal surgery while in lower abdominal surgery the afferent parasympathetic innervation comes from the sacral spinal nerves which can be blocked via the spinal route. This might explain the preemptive analgesic effect described for radical prostatectomy.6,14
In contrast to the above-mentioned single drug applications, Rockemann et al. were able to reduce postoperative analgesic consumption in their study using a multimodal pre-surgical analgesic approach for major abdominal surgery.15 Nevertheless, the use of non-steroidal anti-inflammatory drugs should be evaluated critically, in the presence of potential major bleeding.
Another reason for the ineffectiveness of preemptive analgesia could be pre-existing pain. As described by Aida et al. central sensitization seems to be already established by pre-surgical acute or chronic pain and preserved until the termination of surgery.12 Therefore we included only patients with a preoperative VAS score for pain at rest of 10 mm or less.
Epidural analgesia resulted in a significantly reduced intraoperative opioid requirement in patients of GII in comparison to GI. The higher dosage of intraoperative opioids in GI probably compensated the lack of epidural blockade, in order to provide analgesia comparable to the combination of both techniques in GII. The higher cumulative sufentanil doses in GI did not lead to prolonged mechanical ventilation under the conditions of this study which included transfer of the propofol sedated patients to the ICU and stabilization of temperature and cardiocirculatory variables after the extended surgery.
In spite of contradictory results of studies concerning preemptive analgesia and the lack of effects in the meta-analysis by Moiniche, the concept of preemptive analgesia still remains a topic of intense discussions.13,16,17 Further investigations with respect to mechanisms of development and treatment strategies are required.
In conclusion the pre- and intraoperative epidural administration of ropivacaine 0.375% showed no early preemptive analgesic effect in women undergoing extended abdominal tumour surgery.
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Acknowledgments |
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Footnotes |
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Results of this work have been presented at the German Congress of Anaesthesiology in Nuremberg, June 2001, at the Annual Meeting of the ASA, in New Orleans, October 2001.
Revision received March 12, 2003. Accepted for publication January 14, 2003.
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2 Schug SA, Scott DA, Payne J, Mooney PH, Hagglof B. Postoperative analgesia by continuous extradural infusion of ropivacaine after upper abdominal surgery. Br J Anaesth 1996; 76: 487–91.
3 Scott AM, Starling JR, Ruscher AE, DeLessio ST, Harms BA. Thoracic versus lumbar epidural anesthesia’s effect on pain control and ileus resolution after restorative proctocolectomy. Surgery 1996; 120: 688–97.[Medline]
4 Scott DA, Chamley DM, Mooney PH, Deam RK, Mark AH, Hagglof B. Epidural ropivacaine infusion for postoperative analgesia after major lower abdominal surgery–a dose finding study. Anesth Analg 1995; 81: 982–6.[Abstract]
5 Katz J, Kavanagh BP, Sandler AN, et al. Preemptive analgesia. Clinical evidence of neuroplasticity contributing to postoperative pain. Anesthesiology 1992; 77: 439–46.[Medline]
6 Gottschalk A, Smith DS, Jobes DR, et al. Preemptive epidural analgesia and recovery from radical prostatectomy. A randomized controlled trial. JAMA 1998; 279: 1076–82.
7 Kundra P, Deepalakshmi K, Ravishankar M. Preemptive caudal bupivacaine and morphine for postoperative analgesia in children. Anesth Analg 1998; 87: 52–6.
8 Kucuk N, Kizilkaya M, Tokdemir M. Preoperative epidural ketamine does not have a postoperative opioid sparing effect. Anesth Analg 1998; 87: 103–6.
9 Kilickan L, Toker K. The effects of preemptive intravenous versus preemptive epidural morphine on postoperative analgesia and surgical stress response after orthopaedic procedures. Minerva Anestesiol 2000; 66: 649–55.[Medline]
10 Aguilar JL, Rincon R, Domingo V, Espachs P, Preciado MJ, Vidal F. Absence of an early pre-emptive effect after thoracic extradural bupivacaine in thoracic surgery. Br J Anaesth 1996; 76: 72–6.
11 Aida S, Baba H, Yamakura T, Taga K, Fukuda S, Shimoji K. The effectiveness of preemptive analgesia varies according to the type of surgery: a randomized, double-blind study. Anesth Analg 1999; 89: 711–6.
12 Aida S, Fujihara H, Taga K, Fukuda S, Shimoji K. Involvement of presurgical pain in preemptive analgesia for orthopedic surgery: a randomized double blind study. Pain 2000; 84: 169–73.[Medline]
13 Moiniche S, Kehlet H, Dahl JB. A qualitative and quantitative systematic review of preemptive analgesia for postoperative pain relief. Anesthesiology 2002; 96: 725–41.[Medline]
14 Shir Y, Raja SN, Frank SM. The effect of epidural versus general anesthesia on postoperative pain and analgesic requirements in patients undergoing radical prostatectomy. Anesthesiology 1994; 80: 49–56.[Medline]
15 Rockemann MG, Seeling W, Bischof C, Borstinghaus D, Steffen P, Georgieff M. Prophylactic use of epidural mepivacaine/morphine, systemic diclofenac, and metamizole reduces postoperative morphine consumption after major abdominal surgery. Anesthesiology 1996; 84: 1027–34.[Medline]
16 Brennan T. Frontiers in translational research. The etiology of incisional and postoperative pain. Anesthesiology 2002; 97: 535–7.[Medline]
17 Kawamata M, Watanabe H, Nishikawa K, et al. Different mechanisms of development and maintenance of experimental incision-induced hyperalgesia in human skin. Anesthesiology 2002; 97: 550–9.[Medline]
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P < 0.05 vs baseline.
