基于胸椎旁阻滞的无阿片类麻醉方案促进乳腺癌手术后恢复：一项双中心、前瞻性、随机对照试验

IF 5 2区医学 Q1 ANESTHESIOLOGY

Journal of Clinical Anesthesia Pub Date : 2025-06-17 DOI:10.1016/j.jclinane.2025.111904

Panpan Tong , Ying Guo , Yun Wang , Yuerou Feng , Xiong Song , Guanli Luo , Weiyi Qin , Xiaofan Lu , Liquan Zheng , Haidong Wang , Yali Lu , Renchun Lai

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引用次数: 0

摘要

研究目的评价在胸椎旁阻滞（TPVB）基础上实施无阿片类麻醉（OFA）方案是否能提高乳腺癌手术患者术后早期恢复质量。我们假设，与常规麻醉方案相比，无阿片类药物麻醉与TPVB可以提高24小时的15项恢复质量（QoR-15）。设计一项前瞻性、随机对照试验。单位：中山大学肿瘤中心、甘肃省肿瘤医院。基于最小临床重要差异（MCID） 6.0和假定标准偏差（SD） 16的术后QoR-15评分，共纳入252例接受乳腺癌手术的患者。患者被分配到阿片类药物麻醉（OA）组或OFA组。主要观察指标为术后24 h QoR-15评分。次要结局包括48 h时QoR-15评分、PACU休息和活动时疼痛评分、术后6、12、24和48 h、术后镇痛抢救、恶心、呕吐等不良反应的发生、首次排尿时间和住院时间。主要结果术后24 h， OFA组QoR-15评分的均数和标准误差（SE）为139.12(0.72)，显著高于OA组132.48(0.84)[差异为6.6,95%可信区间（CI）， 4.87 ~ 8.40, P <；0.001]。OFA在48 h的QoR-15评分[145.31(0.67)]也高于OA[142.18(0.88)]。OFA组术后6 h静息NRS评分及术后12 h活动NRS评分均显著低于OA组(P <；0.001)。OFA组术后出现恶心和干呕的患者较少(P <；0.001)。OFA组与OA组在首次排尿时间和住院时间上无统计学差异(P >；0.05)。结论基于TPVB的ofa提高了乳腺癌手术患者的术后恢复质量。试验注册http://www.chictr.org.cn，标识符：ChiCTR2300072501，主要研究员：赖仁春，注册日期：2023-06-15。临床试验注册chictr2300072501。

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Opioid-free anaesthesia protocol based on thoracic paravertebral block enhances postoperative recovery after breast cancer surgery: A two-center, prospective, randomized, controlled trial

Study objective

To evaluate whether the implementation of an opioid-free anaesthesia (OFA) protocol based on thoracic paravertebral block (TPVB) could improve early postoperative recovery quality in patients undergoing breast cancer surgery. We hypothesized that opioid-free anaesthesia with TPVB would improve the 15-item quality of recovery (QoR-15) at 24 h relative to conventional anaesthesia protocol.

Design

A prospective, randomized and controlled trial.

Setting

Sun Yat-Sen University Cancer Center and Gansu Provincial Cancer Hospital.

Patients

Based on a minimal clinically important difference (MCID) of 6.0 and an assumed standard deviation (SD) of 16 for postoperative QoR-15 score, a total of 252 patients undergoing breast cancer surgery were enrolled.

Interventions

Patients were allocated to either opioid-based anaesthesia (OA) group or OFA group.

Measurements

The primary outcome was QoR-15 score at 24 h postoperatively. Secondary outcomes included QoR-15 score at 48 h, numerical rating scale (NRS) pain scores at rest and during activity at PACU, 6, 12, 24, and 48 h postoperatively, postoperative analgesic rescue, the occurrence of adverse effects such as nausea and vomiting, the time to first urination and the length of hospital stay.

Main results

At 24 h postoperatively, means and standard errors (SE) of QoR-15 score were 139.12 (0.72) in the OFA group significantly higher than those in the OA group 132.48 (0.84) [difference of 6.6, 95 % Confidence Interval (CI), 4.87–8.40, P < 0.001]. The QoR-15 score of OFA [145.31 (0.67)] at 48 h is also higher than that of OA [142.18 (0.88)]. The resting NRS score at 6 h and the active NRS score within 12 h after surgery in the OFA group were significantly lower than those in the OA group (P < 0.001). Fewer patients suffered from postoperative nausea and retching in the OFA group (P < 0.001). There were no statistical differences in the time to first urination and length of stay between OFA and OA groups (P > 0.05).

Conclusion

OFA based on TPVB improved the postoperative quality of recovery in patients undergoing breast cancer surgery.

Trial registration

http://www.chictr.org.cn, Identifier: ChiCTR2300072501, principal investigator: Renchun Lai, date of registration: 2023-06-15.

Clinical trial registration

ChiCTR2300072501.

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来源期刊

Journal of Clinical Anesthesia 医学-麻醉学

CiteScore

7.40

自引率

4.50%

发文量

346

审稿时长

23 days

期刊介绍： The Journal of Clinical Anesthesia (JCA) addresses all aspects of anesthesia practice, including anesthetic administration, pharmacokinetics, preoperative and postoperative considerations, coexisting disease and other complicating factors, cost issues, and similar concerns anesthesiologists contend with daily. Exceptionally high standards of presentation and accuracy are maintained. The core of the journal is original contributions on subjects relevant to clinical practice, and rigorously peer-reviewed. Highly respected international experts have joined together to form the Editorial Board, sharing their years of experience and clinical expertise. Specialized section editors cover the various subspecialties within the field. To keep your practical clinical skills current, the journal bridges the gap between the laboratory and the clinical practice of anesthesiology and critical care to clarify how new insights can improve daily practice.