Effects of an opioid-free care pathway vs. opioid-based standard care on postoperative pain and postoperative quality of recovery after laparoscopic bariatric surgery: A multicentre randomised controlled trial.

IF 4.2 2区医学 Q1 ANESTHESIOLOGY

European Journal of Anaesthesiology Pub Date : 2025-08-01 Epub Date: 2025-05-14 DOI:10.1097/EJA.0000000000002193

Alexander Olausson, Pether Jildenstål, Paulin Andréll, Eva Angelini, Erik Stenberg, Ville Wallenius, Henrik Öhrström, Sven-Egron Thörn, Axel Wolf

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引用次数: 0

Abstract

Background: Opioid-free anaesthesia (OFA) may enhance postoperative recovery after bariatric surgery, but its combined effect with opioid-free interventions has not been studied.

Objectives: To compare postoperative pain and recovery after laparoscopic bariatric surgery with a total opioid-free care pathway and conventional opioid-based treatment.

Design: A multicentre nonblinded controlled trial.

Setting: Two university hospitals in Sweden.

Patients: Adult patients scheduled for laparoscopic bariatric surgery were enrolled between May 2019 and November 2023. Of 837 patients screened, 112 were randomised, and 110 were included in the analysis: 55 in the intervention and 55 in the control group.

Interventions: Patients were randomised to an opioid-based standard care (control group) or to an opioid-free care pathway (intervention group), including intraoperative OFA and postoperative first-line transcutaneous electrical nerve stimulation (TENS) treatment.

Main outcome measures: The primary outcome was the change in patient-reported postoperative pain intensity on a numerical rating scale (NRS) from arrival in the postanaesthesia care unit (PACU) until discharge to the surgical ward. Key secondary outcomes were postoperative pain intensity, in-hospital opioid consumption, and postoperative quality of recovery scale (PQRS) scores.

Results: There was no difference between the groups regarding the changes in pain intensity from arrival in PACU until discharge to the ward, with mean ± SD changes in NRS of 3.20 ± 3.01 (intervention) vs. 3.15 ± 2.25 (control); mean difference (MD) 0.04 [(95% confidence interval (CI), -1.00 to 1.08); P = 0.97], and pain intensity at 24 h ( P = 0.078), 72 h ( P = 0.060), and 3 months ( P = 0.30) postoperatively. The intervention group had a significantly lower opioid consumption in the PACU; mean morphine equivalents 6.08 ± 12.31 vs. 51.1 ± 14.9 mg; MD -45.0 (95% CI, -50.1 to -39.8) mg; P < 0.0001; and during the hospital stay MD -40.3 (95% CI, -54.4 to -25.9) mg; P < 0.0001. Total PQRS scores did not differ significantly over the 3-month follow-up.

Conclusion: The opioid-free care pathway offers patients pain relief and recovery outcomes comparable to conventional opioid-based care and reduces opioid use after laparoscopic bariatric surgery.

Trial registration: ClinicalTrials.gov NCT03756961.

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无阿片类药物治疗途径与基于阿片类药物的标准治疗对腹腔镜减肥手术术后疼痛和术后恢复质量的影响：一项多中心随机对照试验

背景：无阿片类麻醉（OFA）可以促进减肥手术后的恢复，但其与无阿片类干预措施的联合效果尚未研究。目的：比较完全无阿片类药物治疗途径和传统阿片类药物治疗的腹腔镜减肥手术术后疼痛和恢复情况。设计：多中心非盲法对照试验。环境：瑞典的两所大学医院。患者：计划在2019年5月至2023年11月期间进行腹腔镜减肥手术的成年患者入组。在筛选的837名患者中，112名被随机分组，110名被纳入分析：55名在干预组，55名在对照组。干预措施：患者被随机分配到以阿片类药物为基础的标准治疗（对照组）或无阿片类药物治疗途径（干预组），包括术中OFA和术后一线经皮神经电刺激（TENS）治疗。主要结局指标：主要结局指标是患者报告的术后疼痛强度（NRS）从到达麻醉后护理病房（PACU）到出院到外科病房的变化。关键的次要结局是术后疼痛强度、住院阿片类药物消耗和术后恢复质量量表（PQRS）评分。结果：两组患者从进入PACU到出院的疼痛强度变化无差异，NRS的平均±SD变化分别为3.20±3.01（干预组）和3.15±2.25（对照组）；平均差（MD） 0.04[95%可信区间（CI）， -1.00 ~ 1.08]；P = 0.97]，术后24 h （P = 0.078）、72 h （P = 0.060）、3个月（P = 0.30）疼痛强度。干预组在PACU的阿片类药物消耗显著降低；吗啡平均当量为6.08±12.31 mg vs. 51.1±14.9 mg；MD -45.0 (95% CI, -50.1 ~ -39.8) mg；结论：与传统的阿片类药物治疗相比，无阿片类药物治疗途径为患者提供了疼痛缓解和康复效果，并减少了腹腔镜减肥手术后阿片类药物的使用。试验注册：ClinicalTrials.gov NCT03756961。

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来源期刊

European Journal of Anaesthesiology 医学-麻醉学

CiteScore

6.90

自引率

11.10%

发文量

351

审稿时长

6-12 weeks

期刊介绍： The European Journal of Anaesthesiology (EJA) publishes original work of high scientific quality in the field of anaesthesiology, pain, emergency medicine and intensive care. Preference is given to experimental work or clinical observation in man, and to laboratory work of clinical relevance. The journal also publishes commissioned reviews by an authority, editorials, invited commentaries, special articles, pro and con debates, and short reports (correspondences, case reports, short reports of clinical studies).