STUDY OBJECTIVE: To evaluate the effect on postoperative pain of intraperitoneal instillation of dilute bupivacaine at the conclusion of laparoscopic hysterectomy. DESIGN: Prospective, randomized, double-blind, placebo-controlled trial (Canadian Task Force classification I). SETTING:Tertiary care, urban, academic teaching hospital. PATIENTS: Women aged 18 to 65 years undergoing total orsupracervical laparoscopic hysterectomy with or without salpingo-oophorectomy. INTERVENTION: Randomization to intraperitoneal instillation of bupivacaine vs normal saline solution at the conclusion of laparoscopic hysterectomy performed because of benign indications. MEASUREMENTS AND MAIN RESULTS: A total of 160 patients consented to participate in the study and were randomized to receive either intraperitoneal instillation of 100 mg bupivacaine in 100 mL normal saline solution or 100 mL normal saline solution alone, at the conclusion of laparoscopic hysterectomy. Sixty seven of 77 patients (87%) in the treatment group and 73 of 80 patients (91%) in the placebo group completed the study. There were no significant differences in demographic profile, indication for hysterectomy, or number of previous surgeries between the two groups. All patients were prescribed a standardized routine postoperative analgesic regimen. Pain was measured by patient self-report using a 10-cm visual analog scale (VAS) at 1, 2, 4, 6, 12, and 24 hours postoperatively. Mean VAS scores at all time points were between 2.0 and 4.3 and were highest in the first postoperative hour. VAS scores were not significantly different between the two groups at any time point. None of the measured secondary outcomes were significantly different between the bupivacaine and placebo groups, including total postoperative opioid analgesic use in morphine equivalents (23.2 mg vs 27.5 mg; p = .09), length of hospital stay in hours (23.3 vs 23.0; p = .49), patient satisfaction on a 10-cm VAS (9.0 vs 8.2; p = .12), and complication rates (9% vs 15%; p = .35). CONCLUSION: Intraperitoneal instillation of bupivacaine at the conclusion of laparoscopic hysterectomy does not reduce postoperative pain. Opioid analgesic use, length of hospital stay, overall patient satisfaction, and complication rates are also unchanged. Self-reported postoperative pain was low in both groups after this major gynecologic surgery performed laparoscopically.
RCT Entities:
STUDY OBJECTIVE: To evaluate the effect on postoperative pain of intraperitoneal instillation of dilute bupivacaine at the conclusion of laparoscopic hysterectomy. DESIGN: Prospective, randomized, double-blind, placebo-controlled trial (Canadian Task Force classification I). SETTING: Tertiary care, urban, academic teaching hospital. PATIENTS: Women aged 18 to 65 years undergoing total or supracervical laparoscopic hysterectomy with or without salpingo-oophorectomy. INTERVENTION: Randomization to intraperitoneal instillation of bupivacaine vs normal saline solution at the conclusion of laparoscopic hysterectomy performed because of benign indications. MEASUREMENTS AND MAIN RESULTS: A total of 160 patients consented to participate in the study and were randomized to receive either intraperitoneal instillation of 100 mg bupivacaine in 100 mL normal saline solution or 100 mL normal saline solution alone, at the conclusion of laparoscopic hysterectomy. Sixty seven of 77 patients (87%) in the treatment group and 73 of 80 patients (91%) in the placebo group completed the study. There were no significant differences in demographic profile, indication for hysterectomy, or number of previous surgeries between the two groups. All patients were prescribed a standardized routine postoperative analgesic regimen. Pain was measured by patient self-report using a 10-cm visual analog scale (VAS) at 1, 2, 4, 6, 12, and 24 hours postoperatively. Mean VAS scores at all time points were between 2.0 and 4.3 and were highest in the first postoperative hour. VAS scores were not significantly different between the two groups at any time point. None of the measured secondary outcomes were significantly different between the bupivacaine and placebo groups, including total postoperative opioid analgesic use in morphine equivalents (23.2 mg vs 27.5 mg; p = .09), length of hospital stay in hours (23.3 vs 23.0; p = .49), patient satisfaction on a 10-cm VAS (9.0 vs 8.2; p = .12), and complication rates (9% vs 15%; p = .35). CONCLUSION: Intraperitoneal instillation of bupivacaine at the conclusion of laparoscopic hysterectomy does not reduce postoperative pain. Opioid analgesic use, length of hospital stay, overall patient satisfaction, and complication rates are also unchanged. Self-reported postoperative pain was low in both groups after this major gynecologic surgery performed laparoscopically.
Authors: Laura A M van Lieshout; Miranda P Steenbeek; Joanne A De Hullu; M Caroline Vos; Saskia Houterman; Jack Wilkinson; Jurgen Mj Piek Journal: Cochrane Database Syst Rev Date: 2019-08-28
Authors: G Nelson; A D Altman; A Nick; L A Meyer; P T Ramirez; C Achtari; J Antrobus; J Huang; M Scott; L Wijk; N Acheson; O Ljungqvist; S C Dowdy Journal: Gynecol Oncol Date: 2016-01-03 Impact factor: 5.482