Analgesic efficacy of continuous wound infiltration compared with continuous intravenous fentanyl after gynaecological surgery: a non‐inferiority, randomised controlled trial

Abstract

AbstractObjectiveThe present trial aimed to prove the non‐inferiority of the analgesic efficacy of continuous wound infiltration (CWI) to that of continuous intravenous fentanyl (IV) and to compare the safety of the two methods.MethodsThis trial was a prospective, single‐centre, two‐arm, non‐inferiority, randomised controlled trial. Patients participating in the trial were randomised to a CWI group or an IV group. The VAS (visual analogue scale), additional analgesic usage and side effects were then compared between the groups.ResultsIn total, 61 patients were enrolled; two in CWI were excluded, leaving 59 (30 in the CWI group and 29 in the IV group) for analysis. The difference in the VAS score at 24 h (CWI group – IV group) was −3.2 (95% confidence interval [CI] −14.7 to 8.2), which was less than the non‐inferiority margin of 15. The mean amount of total fentanyl use at postoperative hour 48 was 1395 (95% CI 886–1903) µg in the CWI group and 3186 (95% CI 2716–3658) µg in the IV group. The amount of other analgesics and the incidence of adverse effects did not differ significantly between the groups.ConclusionCWI was non‐inferior to IV in terms of its analgesic effect, and has an opioid sparing effect in open gynaecological surgery.