• Xiaofen Liu, Jun Hu, Xianwen Hu, Rui Li, Yun Li, Gordon Wong, Ye Zhang, and study group.
• Department of Anaesthesiology and Perioperative Medicine, and The Key Laboratory of Anesthesiology and Perioperative Medicine of Anhui Higher Education Institutes, The Second Hospital of Anhui Medical University, 678 Furong Road, Hefei, Anhui Province, China.
• Pain Ther. 2021 Jun 4.

IntroductionPost-operative visceral pain is common in early postoperative period after laparoscopic surgery. As a kappa opioid receptor agonist, the antinociceptive effects of nalbuphine in visceral pain are consistent across a multitude of experimental conditions irrespective of species. We hypothesized that preemptive nalbuphine can decrease the visceral pain for patients with incisional infiltration of ropivacaine after laparoscopic cholecystectomy.MethodsIn a multicenter, prospective, double-blind, placebo-controlled, randomized clinical trial, 2094 participants scheduled for laparoscopic cholecystectomy were randomly assigned to receive nalbuphine (Nal group, n = 1029) or placebo (Con group, n = 1027). The Nal group received intravenous nalbuphine 0.2 mg·kg-1 and the Con group received saline in a similar way. The primary endpoint was the effect of nalbuphine on post-operative visceral pain intensity scores within 24 h postoperatively. The total amount of analgesic as well as complications were recorded.ResultsA total of 1934 participants were analyzed. Nalbuphine reduced the visceral pain both at rest (β = - 0.1189, 95% CI - 0.23 to - 0.01, P = 0.037) and movement (β = - 0.1076, 95% CI - 0.21 to - 0.01, P = 0.040) compared with placebo. Patients in the Nal group required less frequent supplemental analgesic administration during the first 24 h after surgery. There were fewer patients in the Nal group who experienced nausea and vomiting (PONV) (P = 0.008).ConclusionsPreemptive nalbuphine administered at a dose of 0.2 mg·kg-1 was safe and effective at reducing the postoperative visceral pain and supplemental analgesic use in patients undergoing laparoscopic cholecystectomy.Trial RegistrationChinese Clinical Trial Registry; ChiCTR1800014379.

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