随机对照试验研究方案，旨在探讨胸椎硬膜外和椎旁阻滞对减少慢性开胸术后疼痛的效果：2（TOPIC 2）。

Study protocol for a randomised controlled trial to investigate the effectiveness of thoracic epidural and paravertebral blockade in reducing chronic post-thoracotomy pain: 2 (TOPIC 2).

机构信息

School of Medicine, University of Glasgow, Glasgow, UK.

Institute of Translational Medicine, University of Liverpool, Liverpool, UK.

出版信息

Trials. 2023 Nov 23;24(1):748. doi: 10.1186/s13063-023-07463-1.

DOI:10.1186/s13063-023-07463-1

PMID:37996898

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10666334/

Abstract

BACKGROUND

Thoracotomy is considered one of the most painful surgical procedures and can cause debilitating chronic post-surgical pain lasting months or years postoperatively. Aggressive management of acute pain resulting from thoracotomy may reduce the likelihood of developing chronic pain. This trial compares the two most commonly used modes of acute analgesia provision at the time of thoracotomy (thoracic epidural blockade (TEB) and paravertebral blockade (PVB)) in terms of their clinical and cost-effectiveness in preventing chronic post-thoracotomy pain.

METHODS

TOPIC 2 is a multi-centre, open-label, parallel group, superiority, randomised controlled trial, with an internal pilot investigating the use of TEB and PVB in 1026 adult (≥ 18 years old) patients undergoing thoracotomy in up to 20 thoracic centres throughout the UK. Patients (N = 1026) will be randomised in a 1:1 ratio to receive either TEB or PVB. During the first year, the trial will include an integrated QuinteT (Qualitative Research Integrated into Trials) Recruitment Intervention (QRI) with the aim of optimising recruitment and informed consent. The primary outcome is the incidence of chronic post-surgical pain at 6 months post-randomisation defined as 'worst chest pain over the last week' equating to a visual analogue score greater than or equal to 40 mm indicating at least a moderate level of pain. Secondary outcomes include acute pain, complications of regional analgesia and surgery, health-related quality of life, mortality and a health economic analysis.

DISCUSSION

Both TEB and PVB have been demonstrated to be effective in the prevention of acute pain following thoracotomy and nationally practice is divided. Identification of which mode of analgesia is both clinically and cost-effective in preventing chronic post-thoracotomy pain could ameliorate the debilitating effects of chronic pain, improving health-related quality of life, facilitating return to work and caring responsibilities and resulting in a cost saving to the NHS.

TRIAL REGISTRATION

NCT03677856 [ClinicalTrials.gov] registered September 19, 2018. https://clinicaltrials.gov/ct2/show/NCT03677856 . First patient recruited 8 January 2019.

摘要

背景

开胸手术被认为是最疼痛的外科手术之一，可导致术后数月甚至数年的衰弱性慢性术后疼痛。积极管理开胸手术后的急性疼痛可能会降低发生慢性疼痛的可能性。本试验比较了开胸手术时最常用的两种急性镇痛方式（胸段硬膜外阻滞（TEB）和椎旁阻滞（PVB））在预防慢性开胸手术后疼痛方面的临床和成本效益。

方法

TOPIC 2 是一项多中心、开放标签、平行组、优效性、随机对照试验，内部试验调查了在英国多达 20 个胸科中心的 1026 例成年（≥18 岁）开胸手术患者中使用 TEB 和 PVB 的情况。患者（N=1026）将以 1:1 的比例随机分为 TEB 或 PVB 组。在第一年，试验将包括一个综合 QuinteT（临床试验中的定性研究）招募干预（QRI），旨在优化招募和知情同意。主要结局是 6 个月时慢性术后疼痛的发生率，定义为“过去一周最严重的胸痛”，相当于视觉模拟评分大于或等于 40mm，表明至少有中度疼痛。次要结局包括急性疼痛、区域镇痛和手术并发症、健康相关生活质量、死亡率和卫生经济学分析。