The analgesic efficacy and pharmacokinetics of epidural oxycodone after gynaecological laparotomy: a randomized, double‐blind, double‐dummy comparison with intravenous administration

摘要

Aim The aim of the present study was to compare the analgesic efficacy of epidural and intravenous (i.v.) oxycodone at the same dose. Methods In this randomized, double‐blind, double‐dummy clinical trial, 30 women, aged 24–67?years, undergoing elective gynaecological laparotomy, were administrated either i.v. saline and epidural oxycodone 0.1?mg·kg ?1 (EPI group; n = 15) or i.v. oxycodone 0.1?mg·kg ?1 and epidural saline (IV group; n = 15). For multimodal analgesia, patients received i.v. paracetamol and dexketoprofen, and a triple‐mixture epidural infusion after the first 4?h postoperatively. The primary outcome was the total dose of i.v. fentanyl for rescue analgesia during the first 4?h postoperatively. Results All patients required fentanyl during the first 4?h. The median number of fentanyl doses were three (quartiles 1, 8) in the EPI group and seven (6, 9) in the IV group (mean difference 3.1; 95% confidence interval 0.9, 5.2; P = 0.01). After the first 4?h, the two groups needed a similar total dose of epidural infusion. Patient satisfaction was similarly high in both groups, and both administration routes were well tolerated. Conclusions The data support the superiority of epidural oxycodone compared with that of i.v. administration in pain management after laparotomy.