Département d'Anesthésie Réanimation, Centre Hospitalier Universitaire d'Angers, Angers, France.
INSERM UMR 1246 - SPHERE, Nantes University, Tours University, Nantes, France.
Trials. 2021 Nov 27;22(1):855. doi: 10.1186/s13063-021-05829-x.
Since the 2000s, opioid-free anesthesia (OFA) protocols have been spreading worldwide in anesthesia daily practice. These protocols avoid using opioid drugs during anesthesia to prevent short- and long-term opioid side effects while ensuring adequate analgesic control and optimizing postoperative recovery. Proofs of the effect of OFA protocol on optimizing postoperative recovery are still scarce. The study aims to compare the effects of an OFA protocol versus standard anesthesia protocol on the early quality of postoperative recovery (QoR) from major surgeries.
The SOFA trial is a prospective, randomized, parallel, single-blind, monocentric study. Patients (n = 140) scheduled for major plastic, visceral, urologic, gynecologic, or ear, nose, and throat (ENT) surgeries will be allocated to one of the two groups. The study group (OFA group) will receive a combination of clonidine, magnesium sulfate, ketamine, and lidocaine. The control group will receive a standard anesthesia protocol based on opioid use. Both groups will receive others standard practices for general anesthesia and perioperative care. The primary outcome measure is the QoR-15 value assessed at 24 h after surgery. Postoperative data such as pain intensity, the incidence of postoperative complication, and opioid consumption will be recorded. We will also collect adverse events that may be related to the anesthetic protocol. Three months after surgery, the incidence of chronic pain and the quality of life will be evaluated by phone interview.
This will be the first study powered to evaluate the effect of OFA versus a standard anesthesia protocol using opioids on global postoperative recovery after a wide range of major surgeries. The SOFA trial will also provide findings concerning the OFA impact on chronic pain incidence and long-term patient quality of life.
ClinicalTrials.gov NCT04797312. Registered on 15 March 2021.
自 21 世纪初以来，阿片类药物-free 麻醉（OFA）方案在麻醉日常实践中在全球范围内得到了广泛的应用。这些方案在麻醉过程中避免使用阿片类药物，以防止短期和长期的阿片类药物副作用，同时确保足够的镇痛控制并优化术后恢复。OFA 方案对优化术后恢复效果的证据仍然很少。本研究旨在比较 OFA 方案与标准麻醉方案对主要手术术后早期恢复质量（QoR）的影响。
SOFA 试验是一项前瞻性、随机、平行、单盲、单中心研究。计划接受主要整形、内脏、泌尿科、妇科或耳鼻喉科（ENT）手术的患者（n = 140）将被分配到两组中的一组。研究组（OFA 组）将接受可乐定、硫酸镁、氯胺酮和利多卡因的联合治疗。对照组将接受基于阿片类药物使用的标准麻醉方案。两组均将接受其他全身麻醉和围手术期护理的标准做法。主要观察指标是术后 24 小时评估的 QoR-15 值。将记录术后疼痛强度、术后并发症发生率和阿片类药物消耗量等术后数据。我们还将收集可能与麻醉方案相关的不良事件。术后 3 个月，通过电话访谈评估慢性疼痛发生率和生活质量。
这将是第一项评估 OFA 与使用阿片类药物的标准麻醉方案对广泛的主要手术后整体术后恢复影响的研究。SOFA 试验还将提供有关 OFA 对慢性疼痛发生率和长期患者生活质量影响的研究结果。
ClinicalTrials.gov NCT04797312。于 2021 年 3 月 15 日注册。
