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髋关节置换术后使用羟考酮或舒芬太尼的患者自控静脉镇痛:一项多中心随机对照试验的研究方案

Patient Controlled Intravenous Analgesia with Oxycodone or Sufentanil After Hip Surgery: Study Protocol for a Multi-Centered, Randomized Controlled Trial.

作者信息

Liao Chenxi, Zhu Haibei, Zhong Jie, Lai Xingning, Zhang Boyi, Liao Ren

机构信息

Department of Anesthesiology, West China Hospital, Sichuan University, Chengdu 610041, China.

Research Unit for Perioperative Stress Assessment and Clinical Decision, Chinese Academy of Medical Sciences (2018RU012), West China Hospital, Sichuan University, Chengdu 610041, China.

出版信息

J Clin Med. 2025 Feb 25;14(5):1525. doi: 10.3390/jcm14051525.

Abstract

: Patient-controlled intravenous analgesia (PCIA) after hip surgery should be focused on sufficient analgesia, recovery, and the risk of adverse effects. Sufentanil PCIA offers effective analgesia but with obvious side effects. Oxycodone, a semi-synthetic opioid, is reported to have good analgesic effects with fewer adverse effects compared to strong opioids. We hypothesize that in hip surgery, compared with sufentanil PCIA, oxycodone PCIA in an equipotent dose to sufentanil could achieve similar postoperative analgesia while reducing the incidence of adverse effects associated with strong opioids. : This multi-centered, randomized, controlled open-label clinical trial compares the efficacy of oxycodone and sufentanil for PCIA in hip surgery patients. : A total of 570 subjects will be randomly allocated in a 1:1 ratio into either the oxycodone group or sufentanil group. The primary outcome is the resting numerical rating scale (NRS) pain scores at 2 h after surgery. The secondary outcomes include the incidence of postoperative nausea and vomiting (PONV), NRS pain scores on movement, complications, mobilization time, length of hospital stay, total in-hospital cost, etc. : This trial will provide evidence for the choice of PCIA in hip surgery by comparing the analgesic efficacy and side effects of oxycodone and sufentanil, serving as a foundation for postoperative pain management guidelines and recommendations. Trial Registration: Clinical Trials NCT03685188.

摘要

髋关节手术后的患者自控静脉镇痛(PCIA)应注重充分镇痛、恢复情况以及不良反应风险。舒芬太尼PCIA可提供有效的镇痛效果,但副作用明显。羟考酮是一种半合成阿片类药物,据报道与强效阿片类药物相比,其镇痛效果良好且不良反应较少。我们假设在髋关节手术中,与舒芬太尼PCIA相比,与舒芬太尼等效剂量的羟考酮PCIA在术后可实现相似的镇痛效果,同时降低与强效阿片类药物相关的不良反应发生率。:这项多中心、随机、对照、开放标签的临床试验比较了羟考酮和舒芬太尼用于髋关节手术患者PCIA的疗效。:总共570名受试者将按1:1的比例随机分配到羟考酮组或舒芬太尼组。主要结局指标是术后2小时的静息数字评分量表(NRS)疼痛评分。次要结局指标包括术后恶心呕吐(PONV)的发生率、活动时的NRS疼痛评分、并发症、活动时间、住院时间、住院总费用等。:本试验将通过比较羟考酮和舒芬太尼的镇痛效果及副作用,为髋关节手术中PCIA的选择提供依据,为术后疼痛管理指南和建议奠定基础。试验注册号:ClinicalTrials NCT03685188。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ce6b/11899929/be0c90495565/jcm-14-01525-g001.jpg

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