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

Abstract

ObjectiveThe 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.

Is continuous wound infiltration non‐inferior to continuous intravenous fentanyl for pain control following gynaecological surgery?

“…Dear Dr Papageorghiou, We thank Professor Fu-Shan Xue et al 1 for the insightful response to our article. 2 We appreciate the interest and the valuable questions raised.…”

“…Dear Dr Papageorghiou, We read with great interest the recent article by Kuriyama et al 1 comparing postoperative analgesic efficacy of continuous wound infiltration (CWI) and continuous intravenous fentanyl (IVF) for gynaecological surgery in a non-inferiority, randomised controlled trial. Given that wound infiltration or injection of local anaesthetics is a preferred component of opioid-sparing multimodal analgesia strategies in the current enhanced recovery after surgery (ERAS) practices for gynaecological surgery, 2 their findings have important implications.…”

Continuous wound infiltration can become one effective choice to control postoperative pain: a response to F.S. Xue et. al.

“…Thank you for your insightful response to our article, "Analgesic efficacy of continuous wound infiltration compared with continuous intravenous fentanyl after gynaecological surgery: a non-inferiority randomised controlled trial." 1 We appreciate your interest and the valuable questions you have raised 2 . Please find our responses below.…”