Department of Anesthesiology, E-Da Hospital and I-Shou University, Kaohsiung, Taiwan.
Institute of Biomedical Sciences, College of Medicine, National Sun Yat-Sen University, Kaohsiung, Taiwan.
Medicine (Baltimore). 2023 Aug 4;102(31):e34423. doi: 10.1097/MD.0000000000034423.
A long-acting κreceptor agonist parenteral analgesic may theoretically improve acute pain and reduce incidence of chronic postsurgical pain (CPSP) after laparoscopic cholecystectomy with minimal drug-related side effects of the traditional μreceptor opioids.
Eighty adult patients undergoing elective laparoscopic cholecystectomy were randomly assigned to receive single intramuscular injection of an extended-release sebacoyl dinalbuphine ester (SDE, Naldebain 150 mg; n = 40) or placebo (n = 40) after anesthesia induction. Standard multimodal analgesia (MMA) was administered for postoperative pain control. The primary endpoint was pain intensity within 7 days after surgery. The secondary endpoints were incidence CPSP at 3 months and adverse reactions up to 7 days after surgery.
The highest visual analogue scale (VAS) and area under the curve of VAS 0 to 48 hours after operation were not different between the two groups and a similar proportion of patients requested rescue parenteral analgesics. Average pain intensities were also not different at 72 hours and 7 days after surgery. Incidence of CPSP was 22.5% and 13.1% in patients who received placebo and SDE treatment, respectively (P = .379). Significantly higher incidence of drug-related adverse events, including dizziness, nausea and injection site reactions, were recorded in the SDE group.
A single dose of extended-release analgesic SDE given intraoperatively did not provide sufficient add-on effect for acute and chronic pain management after laparoscopic cholecystectomies in patients who received standard postoperative MMA. Intramuscular injection of 150 mg SDE in patients with average body mass causes adverse events that could have been overlooked. More clinical studies are warranted to determine the target populations who may benefit from SDE injections for improvement of acute and chronic postsurgical pain management.
长效 κ 受体激动剂注射用镇痛药理论上可以改善腹腔镜胆囊切除术后的急性疼痛，并降低慢性术后疼痛（CPSP）的发生率，同时减少传统 μ 受体阿片类药物相关的药物不良反应。
80 例行择期腹腔镜胆囊切除术的成年患者，在麻醉诱导后随机分为接受单次肌肉注射延长释放型sebacoyl 丁丙诺啡酯（SDE，Naldebain 150mg；n = 40）或安慰剂（n = 40）。术后采用标准多模式镇痛（MMA）控制疼痛。主要终点是术后 7 天内的疼痛强度。次要终点是术后 3 个月 CPSP 的发生率和术后 7 天内的不良反应。
两组患者术后 48 小时内最高视觉模拟评分（VAS）和 VAS 曲线下面积无差异，且需要补救性注射用镇痛药的患者比例相似。术后 72 小时和 7 天的平均疼痛强度也无差异。接受安慰剂和 SDE 治疗的患者 CPSP 发生率分别为 22.5%和 13.1%（P =.379）。SDE 组记录到更高比例的与药物相关的不良反应，包括头晕、恶心和注射部位反应。
对于接受标准术后 MMA 的患者，术中单次给予延长释放型镇痛药 SDE 并不能为腹腔镜胆囊切除术后的急性和慢性疼痛管理提供额外的效果。SDE 用于平均体重的患者时，会引起可能被忽视的不良反应。需要更多的临床研究来确定可能受益于 SDE 注射以改善急性和慢性术后疼痛管理的目标人群。
