根据临床试验方法、测量与疼痛评估倡议标准，比较挥发性麻醉与全静脉麻醉对心脏手术后慢性术后疼痛的影响：一项前瞻性随机对照试验的研究方案

Influence of volatile anesthesia versus total intravenous anesthesia on chronic postsurgical pain after cardiac surgery using the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials criteria: study protocol for a prospective randomized controlled trial.

作者信息

Yu Hong, Zheng Jian-Qiao, Hua Yu-Si, Ren Shuo-Fang, Yu Hai

机构信息

Department of Anesthesiology, West China Hospital, Sichuan University & The Research Units of West China (2018RU012), Chinese Academy of Medical Sciences, Chengdu, 610041, People's Republic of China.

Department of Cardiovascular surgery, West China Hospital, Sichuan University & The Research Units of West China (2018RU012), Chinese Academy of Medical Sciences, Chengdu, 610041, People's Republic of China.

出版信息

Trials. 2019 Nov 27;20(1):645. doi: 10.1186/s13063-019-3742-4.

DOI:10.1186/s13063-019-3742-4

PMID:31775854

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6880356/

Abstract

BACKGROUND

Many patients develop chronic postsurgical pain (CPSP) after cardiac surgery, which interferes with their sleep, mood, and quality of life. Studies have suggested that propofol improves postoperative analgesia compared with volatile anesthetics, but its preventive effect on CPSP following cardiac surgery is still unknown. This study compares the incidence of CPSP following cardiac surgery for those receiving volatile anesthesia and those receiving propofol-based total intravenous anesthesia (TIVA) using criteria recommended by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT).

METHODS/DESIGN: This is a prospective randomized controlled trial. In total, 500 adults undergoing cardiac surgery will be randomly allocated to the volatile or the TIVA group. The volatile group will receive sevoflurane or desflurane during surgery as general anesthesia. The TIVA group will receive propofol-based intravenous agents and no volatile agents during surgery. The primary outcomes will be the frequency of CPSP at 3 months, 6 months, and 1 year after surgery. In this case, CPSP is sternal or thoracic pain. It is defined as either (1) numerical rating scale (NRS) > 0 or (2) meeting all six IMMPACT criteria for CPSP. The IMMPACT criteria are validated pain instruments.

DISCUSSION

To our knowledge, this is the first prospective randomized controlled trial to investigate the prevention of CPSP following cardiac surgery for patients receiving volatile anesthesia compared to those receiving propofol-based TIVA using validated pain instruments in accordance with the IMMPACT recommendations. This study will provide important information on which of these two anesthetic regimens is better for preventing CPSP after cardiac surgery.

TRIAL REGISTRATION

Chictr.org.cn, ChiCTR1900020747. Registered on 16 January 2019.

摘要

背景

许多患者在心脏手术后会出现慢性术后疼痛（CPSP），这会干扰他们的睡眠、情绪和生活质量。研究表明，与挥发性麻醉剂相比，丙泊酚可改善术后镇痛效果，但其对心脏手术后CPSP的预防作用仍不清楚。本研究使用临床试验方法、测量与疼痛评估倡议组织（IMMPACT）推荐的标准，比较接受挥发性麻醉和接受丙泊酚全静脉麻醉（TIVA）的患者心脏手术后CPSP的发生率。

方法/设计：这是一项前瞻性随机对照试验。总共500名接受心脏手术的成年人将被随机分配到挥发性麻醉组或TIVA组。挥发性麻醉组在手术期间将接受七氟醚或地氟醚作为全身麻醉。TIVA组在手术期间将接受基于丙泊酚的静脉用药且不使用挥发性麻醉剂。主要结局将是术后3个月、6个月和1年时CPSP的发生频率。在本研究中，CPSP指胸骨或胸部疼痛。其定义为：（1）数字评分量表（NRS）>0；或（2）符合IMMPACT关于CPSP的所有六项标准。IMMPACT标准是经过验证的疼痛评估工具。