May 2001, Vol. 8, No. 2
The Journal of the American Association of Gynecologic Laparoscopists
Effects of Local Bupivacaine Instillation on Pain after Laparoscopy Ahmed Saleh, M.D., Gordon Fox, M.D., Afaf Felemban, M.D., Cecile Guerra, R.N., and Togas Tulandi, M.D.
Abstract Study Objective. To evaluate the effect of preincisional and intraperitoneal bupivacaine administration on immediate and late pain after operative laparoscopy. Design. Randomized study (Canadian Task Force classification I). Setting. University teaching hospital. Patients. One hundred fifty women undergoing laparoscopy for various gynecologic indications. Intervention. A dose of 0.5% bupivacaine 10 ml (50 mg) was injected into cannula sites before incisions and another 10 ml diluted with 100 ml saline into the peritoneal cavity at completion of the procedure. Equal amount of physiologic saline was used in controls. Measurements and Main Results. Modified McGill pain intensity scores and amount of analgesic required in the recovery room and within 24 hours postoperatively were evaluated. Of 150 women, 142 completed the study (71 bupivacaine group, 71 controls). Groups did not differ significantly in body mass index, duration of surgery, return to consciousness, and analgesic requirement during 3-hour observation in the recovery room and 24 hours after discharge. Pain scores were highest 30 minutes after the procedure in both groups. At that time the pain score in the bupivacaine group was lower than that in the control group (1.8 ± 0.2 vs 2.3 ± 0.2, p <0.05). Beyond that time, the groups did not differ in pain scores and analgesic requirements. Conclusion. Postoperative pain is the highest within 30 minutes after laparoscopy. Local instillation of bupivacaine before incision and intraperitoneally was effective in reducing pain immediately after operative laparoscopy, but the effect was not seen beyond 30 minutes. (J Am Assoc Gynecol Laparosc 8(2):203–206, 2001)
sures were effective in reducing the amount of pain in immediate postoperative period but not after discharge.6–9 In others local administration of bupivacaine before skin incision reduced pain 24 hours after discharge but not in the immediate postoperative period.10 Such differences in results could be due to many reasons, such as heterogeneity of patient populations, number of surgeons, inclusion of women undergoing diagnostic laparoscopy or tubal sterilization, and lack of study power. We evaluated effects of preincisional and intraperitoneal bupivacaine
Almost half of admissions after ambulatory gynecologic surgery are due to emesis and pain.1 Pain is more intense after operative laparoscopy than after diagnostic laparoscopy.2,3 Accordingly, patients require more postoperative analgesia and may have associated nausea and vomiting.1 Several strategies are advocated to reduce postoperative pain,4–9 such as injection of local anesthetic into fallopian tubes during laparoscopic sterilization, and infiltration into cannula sites or intraperitoneal instillation.6–9 Results of studies on this subject are conflicting. In some studies these mea-
From the Departments of Obstetrics and Gynecology (Drs. Saleh, Felemban, and Tulandi, and Ms. Guerra), and Anesthesia (Dr. Fox), McGill University, Montreal, Quebec, Canada. Address reprint requests to Togas Tulandi, M.D., Department of Obstetrics and Gynecology, McGill University, Montreal, Quebec H3A 1A1, Canada; fax 1 514 843 1448. Accepted for publication December 7, 2000.
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instillation on immediate and late pain and amount of analgesic required after operative laparoscopy.
cial closure with 1-0 polyglactin was done only for incisions 10 mm or larger.
Materials and Methods
Data Analyses Sample size was determined by power analysis. To detect a 25% difference in reduction of incisional pain between control and bupivacaine groups with 5% level of significance and power of 80%, 140 women (70 women/group) were needed. These estimates were based on 60% of women who experienced pain on wakening after operative laparoscopy.7 Data were analyzed by Student’s t test and repeated measures analysis of variance. Probability below 0.05 was considered statistically significant (two-tailed).
Patients Between February 1999 and April 2000, 150 participants were recruited. Those with a history of hypersensitivity to local anesthesia, women with cardiac or renal disease, and those who underwent conversion to laparotomy were excluded. The research and ethics board approved the protocol. Participants were women admitted to the day surgery unit for diagnostic and/or operative laparoscopy for various gynecologic indications. After providing informed consent, they were randomized into two groups using computer-generated random table numbers. Women in the treatment group (age 33.4 ± 6.0 yrs, body mass index 23.7 ± 4.3 kg/m2) received 0.5% bupivacaine 10 ml (50 mg; Sanofi Canada Inc., Markham, Ontario) into cannula sites before incisions, and bupivacaine 10 ml diluted in 100 ml physiologic saline into the pelvic cavity before peritoneal closure. Those in the control group (age 33.9 ± 6.9 yrs, body mass index 24.6 ± 4.8 kg/m2) received equal volumes of physiologic saline. Bupivacaine or saline was prepared by the anesthetist and recorded by the circulating nurse. The surgeon and pain evaluators were unaware of treatment allocations.
Pain Evaluation All patients were observed in the recovery room. The nurse (CG), who was unaware of treatment allocation, recorded return of consciousness, vital signs, degree of pain, presence of nausea or vomiting, time spent in the recovery room, and amount of analgesic given. Analgesia consisted of oral acetaminophen 300 mg and codeine phosphate 30 mg, or intravenous fentanyl as necessary. The degree of pain was evaluated 30-minute intervals for 3 hours using a modified McGill pain intensity score11 ranging from zero to 5 (0 = no pain, 5 = excruciating pain). At discharge, patients were given a prescription for oral acetaminophen 300 mg-codeine phosphate 30 mg (no patients were allergic to codeine) to be taken only for incisional pain. Women who experienced shoulder pain received reassurance only. Patients were asked to record the degree of pain and time and amount of analgesic taken 4, 8, 12, 16, 20, and 24 hours after surgery. One investigator (AS) who was unaware of treatment allocation conducted telephone interviews the day after surgery.
Operative Technique All laparoscopic procedures were performed by the same surgeon (TT) using three-puncture technique and CO2 insufflation. A 10-mm incision was made for the primary cannula below the umbilicus, a 5-mm incision for a secondary cannula lateral to deep epigastric vessels on the left, and a 5- or 10-mm incision for another secondary cannula on the right. A 10-mm incision was made if removal of a large specimen was anticipated. Occasionally, a larger incision (15–20 mm) was made for morcellating solid specimen. Before making the main incision, 5 ml of solution of either bupivacaine or saline was injected infraumbilically and the remaining solution was divided into 2.5 ml for each secondary cannula site. A standard protocol was used for induction and maintenance of general anesthesia in all cases. A plastic uterine manipulator was used in all cases. At the completion of the procedure and before instillation of bupivacaine or saline, the abdominal cavity was irrigated liberally. Skin incisions were closed with 4-0 plain catgut. Fas-
Results Of 150 women recruited, 8 were excluded (2 conversions to laparotomy, 4 readmissions after laparoscopic hysterectomy, 1 loss of label code, 1 unable to be contacted). Of 142 women who completed the study, 71 were randomized to bupivacaine and 71 to the control group. No side effects to bupivacaine were noted in any patient. The groups did not differ significantly in duration of surgery, time to full wakening, and time to the first analgesia (Table 1). Table 2 shows types of laparoscopic procedures between groups. Tables 3
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May 2001, Vol. 8, No. 2
The Journal of the American Association of Gynecologic Laparoscopists
TABLE 1. Characteristics of Treated Women and Controls
Variable Duration of surgery (min) Time to full wakening (min) Time to first analgesic (min)
Bupivacaine Group (n = 71)
Control Group (n = 71)
44.2 ± 3.0 6.5 ± 0.9 41.5 ± 4.5
43.4 ± 2.5 4.6 ± 0.8 31.0 ± 3.7
TABLE 2. Laparoscopic Procedures
Procedure
Bupivacaine Group
Control Group
17 4 11 10 4 11 1 4 3 6
14 5 20 5 6 1 8 3 3 6
Excision of endometriosis Adhesiolysis Ovarian cystectomy Ovarian drilling Oophorectomy Neosalpingostomy Salpingectomy Tubal reanastomosis Myomectomy Diagnostic
Values are mean ± SE. No values reached significance.
TABLE 3. Pain Score and Fentanyl Requirements in the Recovery Room Time after Completion of Laparoscopy
Bupivacaine group Pain score Fentanyl (µg) Control group Pain score Fentanyl (µg)
30 mina
60 min
90 min
120 min
150 min
180 min
1.8 ± 0.2b 17.0 ± 2.3
1.7 ± 0.2 11.7 ± 2.1
1.4 ± 0.2 8.0 ± 1.7
1.2 ± 0.1 4.8 ± 1.3
1.0 ± 0.1 5.0 ± 1.3
0.8 ± 0.1 4.2 ± 1.2
2.3 ± 0.2 17.8 ± 2.2
1.9 ± 0.2 10.0 ± 1.7
1.5 ± 0.2 8.0 ± 1.5
1.1 ± 0.2 3.5 ± 1.2
0.8 ± 0.1 2.1 ± 0.9
0.8 ± 0.1 4.5 ± 1.2
Values are mean ± SE. aPain scores at 30 minutes were significantly higher than those at 60 minutes (p <0.05) and 90, 120, 150, and 180 minutes (p <0.001). bp <0.05 compared with the control group.
vacaine into cannula sites before incisions and another 10 ml diluted with 100 ml saline into the peritoneal cavity at completion of the procedure decreases immediate (30-min) pain. In another study10 local bupivacaine infiltration into cannula sites at completion of laparoscopy was ineffective, but infiltration before making incisions decreased postoperative pain; however, the authors could not demonstrate the efficacy of bupivacaine in the immediate postoperative period. Pain was reduced only 24 hours after surgery. It is unlikely that this was due to the effects of bupivacaine alone. The drug’s half-life is only 2.7 hours (range 1.2–4.6 hrs). Results of that study could be biased by exclusion of 16 of 75 patients and relatively small number of patients. Administration of local anesthesia before incision is known as preemptive analgesia. It is postulated that the agent prevents afferent signals from reaching
and 4 show pain scores and amounts of analgesic used in the recovery room and first 24 hours after discharge. In both groups, pain scores at 30 minutes were significantly higher than those at 60 minutes (p <0.05), 90, 120, 150, and 180 minutes after surgery (p <0.001). The groups did not differ in amount of fentanyl required. The right secondary cannula incision was 5 mm in 67 patients, 10 mm in 69, and larger than 10 mm in 6. No significant difference was seen in pain scores and amount of analgesic used between women with incisions of 5 and 10 mm or larger (data not shown). Discussion We believe this is the largest study evaluating effects of local anesthetic agent on postlaparoscopic pain. The results show that administration of bupi-
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TABLE 4. Pain Scores and Analgesic Use During the First 24 Hours after Discharge Time after Discharge (hrs)
Bupivacaine group Pain score Analgesic (mg) Control group Pain score Analgesic (mg)
4
8
12
16
20
24
1.4 ± 0.1 19.0 ± 3.1
1.3 ± 0.1 16.0 ± 2.9
1.3 ± 0.1 16.0 ± 2.8
1.3 ± 0.1 12.4 ± 2.7
1.2 ± 0.1 15.0 ± 2.7
1.3 ± 0.1 13.3 ± 2.7
1.7 ± 0.2 25.0 ± 2.9
1.4 ± 0.1 17.6 ± 2.8
1.2 ± 0.1 17.6 ± 3.0
1.2 ± 0.1 9.0 ± 2.1
1.2 ± 0.1 13.3 ± 2.6
1.2 ± 0.1 10.3 ± 2.2
Values are mean ± SE. No values reached significance. The amount of analgesic was based on codeine content (mg).
4. Vabgen O, Doessland S, Lindbeck E: Comparative study of ketolorac and paracetamol/codeine in alleviating pain after gynecologic surgery. J Int Med Res 16:443–451, 1988
the spinal cord.10,12 In our study, despite a decrease in subjective pain immediately after surgery in women given bupivacaine, the amount of analgesia and time to first analgesic were similar to values in controls. In general, we found no difference in pain scores and amount of analgesics beyond 30 minutes after surgery, which suggests that the efficacy of bupivacaine is limited to this brief period. Pain intensity is highest then, and gradually decreases until 120 minutes after surgery. In view of the limited effects of local bupivacaine, its routine administration is not recommended. We did not include patients undergoing tubal sterilization. Tubal sterilization with silastic bands is associated with more pain than diagnostic laparoscopy.13 It is thought that pain after this type of sterilization is due to ischemia and necrosis of the ligated tube without destruction of nerve fibers. The amount of pain seems to be independent of length of incision (5 or ≥10 mm). We conclude that local instillation of bupivacaine before incision and intraperitoneally is effective in reducing immediate postlaparoscopic pain, but is ineffective beyond 30 minutes after the procedure.
5. Lysak SZ, Anderson PT, Carithers RA, et al: Postoperative effects of fentanyl, ketorolac, and piroxicam as analgesics for out patient laparoscopic procedures. Obstet Gynecol 83:270–275, 1994 6. Wheatley SA, Millar JM, Jadad AR: Reduction of pain after laparoscopic sterilization with local bupivacaine: A randomized, parallel, double-blind trial. Br J Obstet Gynaecol 101:443–446, 1994 7. Kelly MC: An assessment of the value of intraperitoneal bupivacaine for analgesia after laparoscopic sterilization. Br J Obstet Gynaecol 103:837–839, 1996 8. Helvacioglu A, Weis R: Operative laparoscopy and postoperative pain relief. Fertil Steril 57:548–552, 1992 9. Johnson N, Onwude JL, Player J, et al: Pain after laparoscopy: An observational study and a randomized trial of local anesthetic. J Gynecol Surg 10:129–138, 1994 10. Ke RW, Portera G, Bagous W, et al: A randomized, double-blinded trial of preemptive analgesia in laparoscopy. Obstet Gynecol 92:972–975, 1998
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