Comparison of oliceridine and sufentanil in postoperative pain management for postoperative nausea and vomiting after bimaxillary orthognathic surgery: an exploratory randomized controlled trial.

BACKGROUND: Postoperative nausea and vomiting (PONV) is a prevalent adverse event following bimaxillary orthognathic surgery, with opioids being a significant contributing factor. Oliceridine, a G protein-biased μ-opioid receptor agonist, reduces activation of the β-arrestin pathway and may decrease gastrointestinal adverse events relative to traditional opioids. This study aimed to evaluate the efficacy and safety of oliceridine relative to sufentanil for postoperative patient-controlled intravenous analgesia (PCIA) in this population, with a particular emphasis on PONV.

METHODS: This prospective, double-blind, randomized controlled exploratory trial was conducted at the Peking University School and Hospital of Stomatology from March to August 2025. A total of 100 eligible patients (ASAI-II, BMI 18-24 kg/m2, aged 18-60 years) were randomly assigned in a 1:1 ratio to receive either oliceridine (0.25 mg/kg combined with tropisetron 10 mg, designated as Group O) or sufentanil (1.25 μg/kg combined with tropisetron 10 mg, designated as Group S) via patient-controlled intravenous analgesia (PCIA), which included a 2 mL/h background infusion, 0.5 mL bolus, 15-min lockout interval. All participants were administered multimodal antiemetic prophylaxis and standardized general anesthesia. The primary outcome measure was the incidence of PONV within 72 h. Secondary outcome measures included the severity of PONV, the use of rescue antiemetics, postoperative pain scores assessed using an 11-point numerical rating scale (NRS), and the occurrence of adverse events. Statistical analyses were conducted using SPSS version 26.0, with a significance threshold set at p < 0.05.

RESULTS: The baseline characteristics were comparable between the groups. The incidence of PONV within 72 h was lower in Group O compared to Group S (40.0% vs. 50.0%; odds ratio [OR] = 0.67, 95% confidence interval [CI]: 0.30-1.47; p = 0.315). Similarly, the incidences of moderate-to-severe PONV (26.0% vs. 36.0%; OR = 0.59, 95% CI: 0.28-1.25; p = 0.108) and the requirement for rescue antiemetics (20.0% vs. 34.0%; OR = 0.49, 95% CI: 0.20-1.20; p = 0.115) were lower in Group O. However, none of these differences reached statistically significance. A repeated-measures analysis of variance (ANOVA) for moderate-to-severe postoperative pain revealed a significant effect of time (F = 17.189, p < 0.001) but no significant group-time interaction (p = 0.142). No serious adverse events, such as respiratory depression or hypotension, were reported in either group, and the incidence of dizziness was similar between the groups (22% vs. 24%, p > 0.05).

CONCLUSION: Oliceridine demonstrated comparable analgesic efficacy and safety to sufentanil, exhibiting numerically lower, albeit not statistically significant, differences in postoperative nausea and vomiting (PONV) and the use of rescue antiemetics. Considering the exploratory nature of this study and the determination of the sample size based primarily on clinical feasibility rather than statistical power, these findings should be regarded as preliminary. Further validation in larger, adequately powered trials incorporating dose-optimization designs is necessary.

CLINICAL TRIAL REGISTRATION: https://www.chictr.org.cn/showproj.html?proj=257554, Identifier: ChiCTR2500096345.