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在加速康复外科(ERAS)方案下,日间手术腹腔镜腹股沟疝修补术中无阿片类药物麻醉与基于阿片类药物麻醉的比较:一项随机非劣效性试验

Opioid-free versus opioid-based anesthesia for day surgery laparoscopic inguinal hernia repair under ERAS protocol: a randomized non-inferiority trial.

作者信息

Wang Chun, Shi Peng, Xu Jun, Fan Xiaohua, Bian Jinjun, Bo Lulong

机构信息

Department of Anesthesiology, The First Affiliated Hospital of Naval Medical University, Shanghai, 200433, China.

Department of Gastrointestinal Surgery, The First Affiliated Hospital of Naval Medical University, Shanghai, 200433, China.

出版信息

Hernia. 2025 Jul 9;29(1):225. doi: 10.1007/s10029-025-03410-y.

DOI:10.1007/s10029-025-03410-y
PMID:40632161
Abstract

PURPOSE

Laparoscopic inguinal hernia repair (LIHR) is increasingly performed as a day surgery procedure under enhanced recovery after surgery (ERAS) protocol. While opioid-based anesthesia (OA) remains standard, its adverse effects may impair postoperative recovery. This randomized controlled non-inferiority trial assessed whether opioid-free anesthesia (OFA) provides non-inferior postoperative pain control to OA for day surgery LIHR under ERAS protocol and evaluated comprehensive recovery outcomes.

METHODS

This single-center, prospective, randomized non-inferiority trial enrolled 90 patients scheduled for day surgery LIHR who were randomly allocated to receive either lidocaine-dexmedetomidine-based OFA (n = 45) or sufentanil-remifentanil-based OA (n = 45). The primary outcome was postoperative 24-h time-weighted average visual analog scale (TWA-VAS) pain score at rest. Secondary outcomes included extended pain assessment, quality of recovery indicators, day surgery pathway efficiency, and perioperative hemodynamic stability.

RESULTS

The 24-h TWA-VAS scores were 1.84 ± 1.02 in the OFA group and 1.77 ± 0.88 in the OA group (mean difference: 0.07; 95% CI: -0.33-0.47), establishing non-inferiority. The OFA group experienced significantly lower rates of intraoperative hypotension (8.9% vs. 53.3%; relative risk: 0.17; P = 0.001) but longer laryngeal mask airway removal time (20 vs. 15 min; P = 0.034) and post-anesthesia care unit stay (50 vs. 45 min; P = 0.018). No significant differences were observed in Quality of Recovery-15 scores, rescue analgesia requirements, postoperative urinary retention (POUR), postoperative nausea and vomiting (PONV), or 24-h discharge success rates.

CONCLUSION

Under ERAS protocol, lidocaine-dexmedetomidine-based OFA provided non-inferior analgesic efficacy to OA for day surgery LIHR, while delivering superior hemodynamic stability. Despite modestly prolonged emergence times, OFA maintained comparable recovery quality and discharge success rates. These findings establish OFA as a valuable alternative anesthetic strategy for day surgery LIHR under ERAS protocol, particularly for patients at risk of opioid-related adverse effects.

TRIAL REGISTRATION

ChiCTR2500098054, registered on February 28, 2025, retrospectively registered.

摘要

目的

腹腔镜腹股沟疝修补术(LIHR)越来越多地作为日间手术,在术后加速康复(ERAS)方案下进行。虽然基于阿片类药物的麻醉(OA)仍是标准麻醉方式,但其不良反应可能会影响术后恢复。这项随机对照非劣效性试验评估了在ERAS方案下,无阿片类药物麻醉(OFA)用于LIHR日间手术时,术后疼痛控制是否不劣于OA,并评估了综合恢复结果。

方法

这项单中心、前瞻性、随机非劣效性试验纳入了计划接受LIHR日间手术的90例患者,将其随机分配接受基于利多卡因-右美托咪定的OFA(n = 45)或基于舒芬太尼-瑞芬太尼的OA(n = 45)。主要结局是术后24小时静息状态下时间加权平均视觉模拟量表(TWA-VAS)疼痛评分。次要结局包括延长的疼痛评估、恢复质量指标、日间手术流程效率和围手术期血流动力学稳定性。

结果

OFA组24小时TWA-VAS评分为1.84±1.02,OA组为1.77±0.88(平均差异:0.07;95%CI:-0.33至0.47),确定为非劣效。OFA组术中低血压发生率显著更低(8.9%对53.3%;相对风险:0.17;P = 0.001),但喉罩拔除时间更长(20分钟对15分钟;P = 0.034),麻醉后监护病房停留时间更长(50分钟对45分钟;P = 0.018)。在恢复质量-15评分、补救性镇痛需求、术后尿潴留(POUR)、术后恶心呕吐(PONV)或24小时出院成功率方面未观察到显著差异。

结论

在ERAS方案下,基于利多卡因-右美托咪定的OFA用于LIHR日间手术时,镇痛效果不劣于OA,同时具有更好的血流动力学稳定性。尽管苏醒时间略有延长,但OFA保持了相当的恢复质量和出院成功率。这些发现确立了OFA作为ERAS方案下LIHR日间手术一种有价值的替代麻醉策略,特别是对于有阿片类药物相关不良反应风险的患者。

试验注册

ChiCTR2500098054,于2025年2月28日注册,回顾性注册。

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