Effect of Oliceridine on the Acute Postoperative Pain Management After Elective Cesarean Delivery: A Randomized Non-Inferiority Trial.

PURPOSE: Effective postoperative analgesia following cesarean delivery is crucial for maternal recovery. Sufentanil, commonly administered via patient-controlled intravenous analgesia (PCIA), is associated with dose-dependent adverse effects, particularly gastrointestinal disturbances. Oliceridine, a novel G protein-biased μ-opioid receptor agonist, offers the dual advantage of potent analgesia and a reduced risk of opioid-related adverse events. This study aimed to compare the analgesic efficacy and the incidence of side effects between the G protein-biased μ-opioid receptor agonist oliceridine and the conventional opioid sufentanil.

PATIENTS AND

METHODS

In this single-center, randomized, double-blind, non-inferiority trial, women undergoing elective cesarean delivery under combined spinal-epidural anesthesia (CSEA) were randomly assigned to receive either oliceridine or sufentanil via patient-controlled intravenous analgesia (PCIA) for 48 hours postoperatively. The primary outcome was the sum of pain intensity differences over 48 hours (SPID48), calculated from resting Numerical Rating Scale (NRS) scores (0-10) assessed at 0, 12, 24, 36, and 48 hours postoperatively. Secondary outcomes included the sum of pain intensity differences at 12 h, 24 h, and 36 h, total PCIA demand, rescue analgesia utilization, time to first lactation, maternal satisfaction, and incidence of adverse events.

RESULTS

160 participants were included in the final analysis. The primary outcome, SPID48, showed an adjusted mean of 172.50 (95% CI, 163.37-181.63) in the oliceridine group and 147.90 (95% CI, 137.59-158.21) in the sufentanil group (mean difference 24.60; 95% CI, 10.83-38.37). The lower limit of the 95% CI for the difference exceeded the pre-specified non-inferiority margin of -20, establishing non-inferiority of oliceridine.

CONCLUSION

Oliceridine provides non-inferior postoperative analgesic efficacy compared with sufentanil in women undergoing cesarean delivery. Exploratory observations suggested a lower incidence of nausea and higher patient satisfaction in the oliceridine group; these findings are hypothesis-generating and require further validation.