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)

摘要

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.