术前与术后超声引导下腹直肌鞘阻滞对改善经腹妇科手术中线开放切口患者疼痛、睡眠质量及细胞因子水平的影响：一项随机对照试验的研究方案
Preoperative versus postoperative ultrasound-guided rectus sheath block for improving pain, sleep quality and cytokine levels of patients with open midline incisions undergoing transabdominal gynaecological operation: study protocol for a randomised controlled trial.
作者信息
Jin Feng, Li Xiao-Qian, Tan Wen-Fei, Ma Hong, Lu Huang-Wei
机构信息
Department of Anaesthesiology, the First Hospital of China Medical University, Shenyang, China.
出版信息
Trials. 2015 Dec 10;16:568. doi: 10.1186/s13063-015-1096-0.
BACKGROUND
Rectus sheath block (RSB) is used for postoperative pain relief in patients undergoing abdominal surgery with midline incision. Preoperative RSB has been shown to be effective, but it has not been compared with postoperative RSB. The aim of the present study is to evaluate postoperative pain, sleep quality and changes in the cytokine levels of patients undergoing gynaecological surgery with RSB performed preoperatively versus postoperatively.
METHODS/DESIGN: This study is a prospective, randomised, controlled (randomised, parallel group, concealed allocation), single-blinded trial. All patients undergoing transabdominal gynaecological surgery will be randomised 1:1 to the treatment intervention with general anaesthesia as an adjunct to preoperative or postoperative RSB. The objective of the trial is to evaluate postoperative pain, sleep quality and changes in the cytokine levels of patients undergoing gynaecological surgery with RSB performed preoperatively (n = 32) versus postoperatively (n = 32). All of the patients, irrespective of group allocation, will receive patient-controlled intravenous analgesia (PCIA) with oxycodone. The primary objective is to compare the interval between leaving the post-anaesthesia care unit and receiving the first PCIA bolus injection on the first postoperative night between patients who receive preoperative versus postoperative RSB. The secondary objectives will be to compare (1) cumulative oxycodone consumption at 24 hours after surgery; (2) postoperative sleep quality, as measured using a BIS-Vista monitor during the first night after surgery; and (3) cytokine levels (interleukin-1, interleukin-6, tumour necrosis factor-α and interferon-γ) during surgery and at 24 and 48 hours postoperatively.
DISCUSSION
Clinical experience has suggested that RSB is a very effective postoperative analgesic technique, and we will answer the following questions with this trial. Do preoperative block and postoperative block have the same duration of analgesic effects? Can postoperative block extend the analgesic time? The results of this study could have actual clinical applications that could help to reduce postoperative pain and shorten hospital stays.
TRIAL REGISTRATION
Current Controlled Trials NCT02477098 15 June 2015.
背景
腹直肌鞘阻滞（RSB）用于经中线切口行腹部手术患者的术后镇痛。术前RSB已被证明有效，但尚未与术后RSB进行比较。本研究的目的是评估术前与术后行RSB的妇科手术患者的术后疼痛、睡眠质量及细胞因子水平变化。
方法/设计：本研究为一项前瞻性、随机、对照（随机、平行组、隐匿分配）、单盲试验。所有经腹妇科手术患者将按1:1随机分为治疗干预组，在全身麻醉基础上辅助术前或术后RSB。试验目的是评估术前（n = 32）与术后（n = 32）行RSB的妇科手术患者的术后疼痛、睡眠质量及细胞因子水平变化。所有患者，无论分组如何，均接受羟考酮患者自控静脉镇痛（PCIA）。主要目的是比较术前与术后行RSB患者在术后第一晚离开麻醉后恢复室至首次接受PCIA推注之间的时间间隔。次要目的将是比较：（1）术后24小时羟考酮累计用量；（2）术后第一晚使用BIS-Vista监测仪测量的术后睡眠质量；（3）手术期间及术后24小时和48小时的细胞因子水平（白细胞介素-1、白细胞介素-6、肿瘤坏死因子-α和干扰素-γ）。
讨论
临床经验表明RSB是一种非常有效的术后镇痛技术，我们将通过本试验回答以下问题。术前阻滞和术后阻滞的镇痛效果持续时间是否相同？术后阻滞能否延长镇痛时间？本研究结果可能具有实际临床应用价值，有助于减轻术后疼痛并缩短住院时间。
试验注册
Current Controlled Trials NCT02477098，2015年6月15日。
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