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经皮耳迷走神经刺激对腹腔镜胆囊切除术患者术后疼痛的影响:一项单中心、前瞻性、随机、双盲、对照研究的研究方案

Effect of transcutaneous auricular vagus nerve stimulation on postoperative pain in patients undergoing laparoscopic cholecystectomy: study protocol for a single-centre, prospective, randomised, double-blind, controlled study.

作者信息

Zhang Qin, Zhang Ling, Wang Dongxu, Cao Ya, Yu Liang, Li Zhonghua, Fan Keyu, Liu Mingxia, Wei Jingqiu, Wang Qianrong, Liu He

机构信息

The Fifth School of Clinical Medicine of Zhejiang Chinese Medical University, Huzhou Central Hospital, Huzhou, Zhejiang, China.

The Fifth School of Clinical Medicine of Zhejiang Chinese Medical University, Huzhou Central Hospital, Huzhou, Zhejiang, China

出版信息

BMJ Open. 2025 Aug 1;15(7):e098506. doi: 10.1136/bmjopen-2024-098506.


DOI:10.1136/bmjopen-2024-098506
PMID:40750272
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12315001/
Abstract

INTRODUCTION: Pain after laparoscopic cholecystectomy (LC) is different from open cholecystectomy, characterised by visceral pain, parietal pain and shoulder pain, which affects postoperative recovery in patients undergoing LC. Recent studies have demonstrated the clinical efficacy of transcutaneous auricular vagus nerve stimulation (taVNS) in both acute and chronic pain treatment. The objective of this study protocol is to investigate the efficacy of taVNS in alleviating postoperative pain following LC. METHODS AND ANALYSIS: In this single-centre, prospective, randomised, double-blind and controlled study, we will enrol 88 participants, aged between 18 and 65 years, who are scheduled for elective LC, and they will be randomly assigned to either the taVNS group (group T) or the control group (group C). For the primary outcome, we will compare the difference in pain score 6 hours after LC assessed using the Numeric Rating Scale. For the secondary outcomes, we will compare the difference including Quality of Recovery-15, Self-rating Depression Scale, Pittsburgh Sleep Quality Index and Postoperative Nausea and Vomiting score. ETHICS AND DISSEMINATION: The Ethics Committee of Huzhou Central Hospital granted approval for the study with approval number: 202301007-01. Dissemination will be via national anaesthesia conferences and publication in the peer-reviewed literature. TRIAL REGISTRATION NUMBER: ChiCTR2300068410.

摘要

引言:腹腔镜胆囊切除术(LC)后的疼痛与开腹胆囊切除术不同,其特点为内脏痛、腹壁痛和肩部疼痛,这会影响接受LC患者的术后恢复。最近的研究表明,经皮耳迷走神经刺激(taVNS)在急性和慢性疼痛治疗中均具有临床疗效。本研究方案的目的是探讨taVNS在减轻LC术后疼痛方面的疗效。 方法与分析:在这项单中心、前瞻性、随机、双盲和对照研究中,我们将招募88名年龄在18至65岁之间、计划进行择期LC的参与者,他们将被随机分配到taVNS组(T组)或对照组(C组)。对于主要结局,我们将比较使用数字评分量表评估的LC术后6小时疼痛评分的差异。对于次要结局,我们将比较包括恢复质量-15、自评抑郁量表、匹兹堡睡眠质量指数和术后恶心呕吐评分在内的差异。 伦理与传播:湖州市中心医院伦理委员会批准了本研究,批准号:202301007-01。传播将通过全国麻醉会议以及在同行评审文献上发表。 试验注册号:ChiCTR2300068410。

相似文献

[1]
Effect of transcutaneous auricular vagus nerve stimulation on postoperative pain in patients undergoing laparoscopic cholecystectomy: study protocol for a single-centre, prospective, randomised, double-blind, controlled study.

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本文引用的文献

[1]
Efficacy and Safety of Different Preemptive Analgesia Measures in Pain Management after Laparoscopic Cholecystectomy: A Systematic Review and Network Meta-Analysis of Randomized Controlled Trials.

Pain Ther. 2024-12

[2]
Analgesic efficacy of erector spinae plane block versus transversus abdominis plane block for laparoscopic cholecystectomy: a systematic review and meta-analysis of randomized controlled trial.

Front Med (Lausanne). 2024-7-29

[3]
Pain management after laparoscopic cholecystectomy: A systematic review and procedure-specific postoperative pain management (PROSPECT) recommendations.

Eur J Anaesthesiol. 2024-11-1

[4]
Preoperative Bilateral External Oblique Intercostal Plus Rectus Sheath Block for Postoperative Pain Management Following Laparoscopic Cholecystectomy: A Noninferior Double-Blind Placebo-Controlled Trial.

Clin J Pain. 2024-10-1

[5]
A novel comparison of erector spinae plane block and paravertebral block in laparoscopic cholecystectomy.

Rev Assoc Med Bras (1992). 2024-4-22

[6]
Cutaneous sensory block area of the ultrasound-guided subcostal transversus abdominis plane block: an observational study.

Reg Anesth Pain Med. 2024-4-2

[7]
Opioid Prescribing Variation After Laparoscopic Cholecystectomy in the US Military Health System.

J Surg Res. 2024-5

[8]
Efficacy of intravenous lidocaine for post-laparoscopic cholecystectomy analgesia: A systematic review and meta-analysis.

Asian J Surg. 2023-12

[9]
International Consensus Based Review and Recommendations for Minimum Reporting Standards in Research on Transcutaneous Vagus Nerve Stimulation (Version 2020).

Front Hum Neurosci. 2021-3-23

[10]
Transcutaneous Auricular Vagus Nerve Stimulation: From Concept to Application.

Neurosci Bull. 2021-6

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