Randomized clinical trial of combined preincisional infiltration and intraperitoneal instillation of levobupivacaine for postoperative pain after laparoscopic cholecystectomy

Abstract

BACKGROUND: Postoperative pain is one of the main reasons for a prolonged hospital stay after laparoscopic cholecystectomy (LC). Reduced postoperative pain might result in faster recovery and establish LC as a day-care surgical procedure. Peroperative local anaesthesia has been suggested to reduce postoperative pain. The aim of this study was to determine the effect of combined subcutaneous infiltration and intraperitoneal instillation of levobupivacaine before the start of LC on postoperative abdominal pain up to 24 h after surgery. METHODS: Patients eligible for elective LC were randomized to receive preincisional infiltration and preoperative intraperitoneal instillation of 80 ml of either 0·125 per cent levobupivacaine (experimental group) or normal saline (placebo group). The primary outcome measure was abdominal pain estimated by means of a visual analogue scale at 0·5, 2, 4, 8 and 24 h after surgery. RESULTS: Eighty of the 101 patients assessed for eligibility were randomized. There was no significant reduction in postoperative abdominal pain with levobupivacaine compared with placebo during the 24-h follow-up; the overall difference in pain score was 2·2 (95 per cent confidence interval - 4·9 to 9·3; P = 0·540). The duration of operation, use of anaesthesia, use of rescue analgesia, shoulder pain, duration of hospital stay and time to resumption of normal daily activities did not differ between the two groups. CONCLUSION: Combined subcutaneous and intraperitoneal administration of levobupivacaine did not influence postoperative abdominal pain after LC. REGISTRATION NUMBER: NCT01199406 (http://www.clinicaltrials.gov).