Drug Design, Development and Therapy (Mar 2022)
A Dose-Response Relationship Study of Prophylactic Nalbuphine to Reduce Pain During the Awakening Period in Patients Undergoing Laparoscopic Total Hysterectomy: A Randomized, Controlled, Double-Blind Clinical Study
Abstract
Min Wang,1,2,* Dongyue Wang,1,* Jingzhi Zuo,3 Tianyu Liu,4 Zheng Niu,5 Juan Xie,1 Dunyi Qi2 1Department of Anesthesiology, Jinshan Hospital of Fudan University, Shanghai, People’s Republic of China; 2Department of Anesthesiology, Affiliated Hospital of Xuzhou Medical University, Xuzhou, Jiangsu, People’s Republic of China; 3Emergency Department, Yichang Central People’s Hospital, Yichang, Hubei, People’s Republic of China; 4Department of Anesthesiology, Peking University People’s Hospital, Beijing, People’s Republic of China; 5Department of Anesthesiology, Zhangjiagang First People’s Hospital, Zhangjiagang, Jiangsu, People’s Republic of China*These authors contributed equally to this workCorrespondence: Dunyi Qi, Department of Anesthesiology, Affiliated Hospital of Xuzhou Medical University, Xuzhou, Jiangsu, People’s Republic of China, Email [email protected]: Prophylactic intravenous nalbuphine was administered to observe its median effective dose (ED50) in reducing pain after undergoing laparoscopic total hysterectomy. To investigate the effect of different doses of nalbuphine on postoperative analgesia and adverse reactions in patients.Patients and Methods: The 120 patients undergoing laparoscopic total hysterectomy were divided into 6 groups: group C (control) and group P (5 different doses of nalbuphine) with 20 patients per group. The doses of nalbuphine in group P were in an equally proportional series (groups P1, P2, P3, P4, and P5 received doses of 0.280, 0.200, 0.140, 0.100, and 0.070 mg/kg, respectively), diluted to 20 mL with saline and administered 5 min before the induction of anesthesia. A similar volume (20 mL) of saline was administered to group C 5 min before the induction of anesthesia. The numeric rating scale (NRS) of patients during awakening and after surgery, the number of postoperative salvage analgesia, and the occurrence of postoperative adverse effects were recorded.Results: The ED50 (95% confidence interval (CI)) of nalbuphine in preventing pain during the awakening period in patients calculated using the point-slope method was 0.125 (0.108, 0.145) mg/kg. NRS scores differed among the 6 groups at 30 min and 1 h after extubation (P 0.05).Conclusion: The ED50 (95% CI) of nalbuphine as a prophylactic in reducing pain during recovery was 0.125 (0.108, 0.145) mg/kg. Compared with the control, nalbuphine at doses of 0.140, 0.200, and 0.280 mg/kg prevented pain during the awakening period. Among these doses, 0.280 mg/kg was determined to be the best, the occurrence of cough was less during extubation and the postoperative analgesic effect was good. However, it is necessary to pay attention to the occurrence of adverse reactions.Keywords: gynecology, laparoscopy, preventive analgesia, nalbuphine, ED50