腹腔镜腹疝修补术后疼痛：布比卡因溶液与生理盐水溶液浸泡补片的效果比较：一项随机对照试验（HAPPIEST试验）

Post-operative pain after laparoscopic ventral hernia repair, the impact of mesh soakage with bupivacaine solution versus normal saline solution: A randomised controlled trial (HAPPIEST Trial).

作者信息

Chawla Tabish, Shahzad Noman, Ahmad Khabir, Ali Jehangir Farman

机构信息

Department of Surgery, Aga Khan University Hospital, Karachi, Pakistan.

Department of Surgery, Queen Elizabeth the Queen Mother Hospital, East Kent Hospitals University NHS Foundation Trust, United Kingdom.

出版信息

J Minim Access Surg. 2020 Oct-Dec;16(4):328-334. doi: 10.4103/jmas.JMAS_50_19.

DOI:10.4103/jmas.JMAS_50_19

PMID:32978352

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7597881/

Abstract

BACKGROUND AND AIMS

Early postoperative pain after laparoscopic ventral hernia repair remains a concern for patients. Local application of anaesthetic agent in the surgical dissection area can potentially overcome this problem. The objective of this study was to evaluate the impact of soaking mesh in 0.5% bupivacaine solution as compared to normal saline solution on the post-operative pain.

METHODOLOGY

We conducted a parallel-design double-blind randomised controlled trial. Adult patients with uncomplicated ventral abdominal wall hernias were included in the trial. Mesh was soaked in 0.5% solution of bupivacaine before application in patients in the intervention arm, whereas it was soaked in normal saline solution for patients in the control arm. Post-operative pain was assessed by trained staff at 6 h and 24 h from surgery. It was graded on visual analogue scale (VAS) from 0 to 10.

RESULTS

Trial was conducted from 16 November, 2015, to 15 September, 2017. During the study period, a total of 114 patients were randomised. Nine patients were excluded after randomisation. A total of 55 patients were analysed in the intervention arm and 50 patients were analysed in the control arm. Mean pain score at VAS at 6 h after laparoscopic ventral hernia repair in the intervention arm was 5.05 ± 1.2, whereas in the control arm, it was 5.54 ± 1.1 and the difference was statistically significant (P = 0.03-independent sample t-test). Mean pain score at VAS at 24 h after laparoscopic ventral hernia repair in the intervention arm was 3.16 ± 1.2, whereas in the control arm, it was 3.58 ± 1.4 and the difference was not statistically significant (P = 0.11-independent sample t-test).

CONCLUSION

Soakage of mesh in 0.5% bupivacaine solution before application in laparoscopic ventral hernia repair significantly reduces early post-operative pain.

TRIAL REGISTRATION

Trial was registered with clinicaltrials. gov (NCT03035617)URL: https://clinicaltrials. gov.

摘要

背景与目的

腹腔镜腹疝修补术后早期疼痛仍是患者关注的问题。在手术解剖区域局部应用麻醉剂可能会解决这一问题。本研究的目的是评估与生理盐水相比，将补片浸泡在0.5%布比卡因溶液中对术后疼痛的影响。

方法

我们进行了一项平行设计的双盲随机对照试验。纳入患有单纯性腹前壁疝的成年患者。干预组患者在应用补片前将其浸泡在0.5%布比卡因溶液中，而对照组患者的补片浸泡在生理盐水中。术后疼痛由经过培训的工作人员在术后6小时和24小时进行评估。采用视觉模拟评分法（VAS）从0至10分进行分级。

结果

试验于2015年11月16日至2017年9月15日进行。在研究期间，共有114例患者被随机分组。随机分组后9例患者被排除。干预组共分析了55例患者，对照组共分析了50例患者。腹腔镜腹疝修补术后6小时，干预组VAS平均疼痛评分为5.05±1.2，而对照组为5.54±1.1，差异有统计学意义（P=0.03，独立样本t检验）。腹腔镜腹疝修补术后24小时，干预组VAS平均疼痛评分为3.16±1.2，而对照组为3.58±1.4，差异无统计学意义（P=0.11，独立样本t检验）。