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一项随机对照试验方案:优化单孔电视辅助胸腔镜手术的围手术期镇痛方案。

Protocol for a randomised controlled trial: optimisation of perioperative analgesia protocol for uniportal video-assisted thoracoscopic surgery.

机构信息

Anesthesiology, China-Japan Friendship Hospital, Beijing, China.

Department of Thoracic Surgery, China-Japan Friendship Hospital, Beijing, China.

出版信息

BMJ Open. 2024 Apr 2;14(4):e079434. doi: 10.1136/bmjopen-2023-079434.

Abstract

INTRODUCTION

Postoperative pain after thoracic surgery impairs patients' quality of life and increases the incidence of respiratory complications. Optimised analgesia strategies include minimally invasive incisions, regional analgesia and early chest tube removal. However, little is known about the optimal analgesic regimen for uniportal video-assisted thoracoscopic surgery (uVATS).

METHODS AND ANALYSIS

We will conduct a single-centre, prospective, single-blind, randomised trial. The effects of postoperative analgesia will be tested using thoracic paravertebral block (PVB) in combination with patient-controlled intravenous analgesia (PVB+PCIA), erector spinae plane block (ESPB) in combination with patient-controlled intravenous analgesia (ESPB+PCIA) or PCIA alone; 102 patients undergoing uVATS will be enrolled in this study. Patients will be randomly assigned to the PVB group (30 mL of 0.33% ropivacaine with dexamethasone), ESPB group (40 mL of 0.25% ropivacaine with dexamethasone) or control groups. PCIA with sufentanil will be administered to all patients after surgery. The primary outcome will be total opioid consumption after surgery. Secondary outcomes include postoperative pain score; postoperative chronic pain at rest and during coughing; sensations of touch and pain in the chest wall, non-opioid analgesic consumption; length of stay; ambulation time, the total cost of hospitalisation and long-term postoperative analgesia. Adverse reactions to analgesics and adverse events related to the regional blocks will also be recorded. The statisticians will be blinded to the group allocation. Comparison of the continuous data among the three groups will be performed using a one-way analysis of variance to assess differences among the means.

ETHICS AND DISSEMINATION

The results will be published in patient education courses, academic conferences and peer-reviewed journals.

TRIAL REGISTRATION NUMBER

NCT06016777.

摘要

简介

胸外科手术后的疼痛会降低患者的生活质量,并增加呼吸系统并发症的发生率。优化的镇痛策略包括微创切口、区域镇痛和早期胸腔引流管拔除。然而,对于单孔电视辅助胸腔镜手术(uVATS),我们对于最佳的镇痛方案知之甚少。

方法和分析

我们将开展一项单中心、前瞻性、单盲、随机试验。将通过胸椎旁阻滞(PVB)联合患者自控静脉镇痛(PVB+PCIA)、竖脊肌平面阻滞(ESPB)联合患者自控静脉镇痛(ESPB+PCIA)或单纯 PCIA 来测试术后镇痛的效果,共纳入 102 例接受 uVATS 的患者。患者将被随机分配到 PVB 组(30ml 含地塞米松的 0.33%罗哌卡因)、ESPB 组(40ml 含地塞米松的 0.25%罗哌卡因)或对照组。所有患者术后均给予舒芬太尼 PCIA。主要结局将是术后总阿片类药物消耗量。次要结局包括术后疼痛评分;术后静息和咳嗽时的慢性疼痛;胸壁的触觉和疼痛感觉、非阿片类镇痛药的消耗;住院时间;活动时间、住院总费用和长期术后镇痛。还将记录阿片类药物不良反应和与区域阻滞相关的不良事件。统计人员将对分组情况保持盲态。将使用单因素方差分析比较三组间的连续数据,以评估均值间的差异。

伦理和传播

结果将发表在患者教育课程、学术会议和同行评议期刊上。

试验注册号

NCT06016777。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e3e6/10989176/15aee40dd745/bmjopen-2023-079434f01.jpg

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