Effect of preventive precision multimodal analgesia (PPMA) on postoperative acute pain process and rehabilitation in adult patients undergoing thoracoscopic pulmonary resection: protocol for a prospective, multicentre, randomised controlled study

预防性精准多模式镇痛(PPMA)对接受胸腔镜肺切除术的成年患者术后急性疼痛过程及康复的影响:一项前瞻性、多中心、随机对照研究方案

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Abstract

INTRODUCTION: Postoperative acute pain following video-assisted thoracoscopic surgery (VATS) impedes patient rehabilitation. While multimodal analgesia effectively mitigates postoperative acute pain and facilitates the postoperative rehabilitation process, the efficacy of preventive precision multimodal analgesia (PPMA) remains uncertain. This study designs a PPMA strategy targeting incisional pain, inflammatory pain and visceral pain in VATS. It aims to investigate the impact of the PPMA strategy on the postoperative acute pain process and rehabilitation outcomes. METHOD AND ANALYSIS: This multicentre, single-blinded, randomised controlled trial will enrol adult patients scheduled for elective thoracoscopic lobectomy or segmentectomy. A total of 1372 participants will be recruited and randomly allocated in a 1:1 ratio to either the preventive precision multimodal analgesia group (PPMA Group) or the conventional multimodal analgesia group (CMA Group). Patients in the PPMA Group will receive a regimen consisting of local anaesthetic infiltration of surgical incision (for incisional pain), intravenous injection of oxycodone (for visceral pain) and parecoxib sodium (for inflammatory pain) before surgery initiation. Patients in the CMA Group will receive the same regimen after specimen isolation. This trial will be conducted across 13 medical centres in China from 2023 to 2026. The primary outcome is the duration of postoperative acute pain. Secondary outcomes include postoperative analgesic consumption, postoperative pain scores, intraoperative haemodynamic parameters and the Indexes of Consciousness (IoC(1) and IoC(2)), as well as intraoperative arterial blood gas and ventilation parameters, intraoperative dosages of general anaesthesia, inflammatory markers at predefined time points, postoperative rehabilitation process and perioperative adverse events and complications. ETHICS AND DISSEMINATION: This study has been approved by the Ethics Committee of Xuanwu Hospital, Capital Medical University (Linyanshen[2023]-NO.012-003-Revised Vision 1). The results will be published in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: Chinese Clinical Trial Registry (ChiCTR2300072176).

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