Background Intrathecal morphine (ITM) provides effective postoperative analgesia in living donor hepatectomy but has significant adverse effects. Studies support the efficacy of erector spinae plane (ESP) blocks in laparoscopic abdominal surgery; we therefore hypothesized that they would provide non-inferior postoperative analgesia compared with ITM and reduce postoperative nausea/vomiting and pruritus. We conducted a randomized, controlled, non-inferiority trial to compare the analgesic efficacy of ITM and bilateral single-injection ESP blocks in laparoscopic donor hepatectomy.
Methods Fifty-four donors were randomized to receive bilateral ESP blocks with 20 mL 0.5% ropivacaine (n=27) or 400 µg ITM (n=27). Primary outcome was resting pain score 24 hours postoperatively measured on an 11-point numeric rating scale. The prespecified non-inferiority limit was 1. Incidences of postoperative nausea/vomiting and pruritus were assessed.
Results The mean treatment difference (ESP–ITM) in the primary outcome was 1.2 (95% CI 0.7 to 1.8). The 95% CI upper limit exceeded the non-inferiority limit. Opioid consumption and all other pain measurements were similar between groups up to 72 hours postoperatively. The ESP group had significantly lower incidences of postoperative vomiting (p=0.002) and pruritus (p<0.001).
Conclusions Bilateral single-injection ESP blocks resulted in higher resting pain scores 24 hours postoperatively compared with ITM and thus did not meet the study definition of non-inferiority. However, the pain intensity with ESP blocks was mild (mean pain scores <3/10) and associated with reduced incidence of postoperative vomiting and pruritus. It warrants further investigation as an analgesic option after laparoscopic living donor hepatectomy.
Trial registration number KCT0003191.
- regional anesthesia
- pain outcome measurement
- opioids, adverse effects
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RK and KJC are joint first authors.
Contributors RAK, KJC, and JSK: planning, conception and design of the study, analyzed the data, interpretation of data, wrote the manuscript, and revised the manuscript. MSG, GSK, and SJC: planning and conducting the study, reporting and acquisition of data, analyzed the data, and gave critical comments. JMK and GSC: performed all surgeries, postoperative management, interpretation of data, and gave critical comments.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests None declared.
Patient consent for publication Not required.
Ethics approval This study received approval from the Samsung Medical Center Research Ethics Board (SMC 2018-05-117-001). Written informed consent was obtained from all participants.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement Data are available upon reasonable request.