A Randomized Double-Blind Study Evaluating Intraperitoneal Ropivacaine Nebulization With and Without Nalbuphine for Post-operative Analgesia in Laparoscopic Cholecystectomy.

Abstract

Objective:Local anaesthetics administered into the peritoneal cavity have been successfully used for post-operative pain relief in minimally invasive laparoscopic procedures. We intended to study and compare nebulized intraperitoneal ropivacaine with and without nalbuphine, with a placebo for post-operative pain relief in these surgeries.Methods:A prospective, randomized double-blinded study was conducted over a period of 1 year after institutional ethical clearance, in patients undergoing elective laparoscopic cholecystectomy. Subjects were randomized into 3 groups (S: saline, R: ropivacaine, RN: ropivacaine plus nalbuphine). The pain was assessed in the post-operative period using NRS scores (up to 24 hours). Kruskal-Wallis test was used for comparison, P < .05 was considered significant. Time to first rescue analgesia, total opioid requirement, and side effects were also recorded.Results:Groups were similar in terms of demographic data. Patients in the placebo group reported higher NRS scores than the other 2 study groups till 4 hours post-operative (earlier rescue analgesia). The addition of nalbuphine did not cause any statistically significant improvement in post-operative pain relief (NRS) as compared to ropivacaine administered alone. Intraperitoneal ropivacaine nebulization had no significant adverse effect as compared to placebo.Conclusions:Ropivacaine nebulization with or without nalbuphine is more effective than placebo for post-operative pain relief after laparoscopic cholecystectomy without significant side effects. Addition of nalbuphine to ropivacaine nebulization does not significantly improve pain relief after laparoscopic cholecystectomy.