Tegileridine versus Sufentanil for Patient-Controlled Intravenous Analgesia After Cesarean Delivery: A Randomized Double-Blind Trial

Abstract

Background Postoperative nausea and vomiting (PONV) remains one of the most common opioid-related adverse events after cesarean delivery despite multimodal analgesia. Tegileridine, a biased μ-opioid receptor agonist, may offer effective analgesia with fewer opioid-related adverse events. This randomized, double-blind trial compared tegileridine versus sufentanil for patient-controlled intravenous analgesia (PCIA) after cesarean delivery. Methods Chinese Clinical Trial Registry number: ChiCTR2600123056. Ninety-four parturients scheduled for elective cesarean were randomized to receive PCIA with tegileridine 5 mg or sufentanil 100 μg. The primary outcome was the 48-hour incidence of PONV. Secondary outcomes included other opioid-related adverse events (ORAEs), pain scores, PCIA bolus counts, rescue analgesia, Quality of Recovery 15 (QoR-15) scores, ambulation time, and hospital stay. Results Ninety-two participants completed the study. Compared with the sufentanil group, the tegileridine group had a lower incidence of PONV (6.5% vs 23.9%; RR = 0.27 (95% CI: 0.08–0.91); OR = 0.22 (95% CI: 0.06–0.86); ARD = −17.4% (95% CI: −31.6 to −3.1%); P=0.039) and dizziness (6.5% vs 26.1%; P=0.022). Postoperative pain scores, PCIA bolus counts, rescue analgesic requirements, ambulation time, and hospital stay showed no statistically significant differences between groups. QoR-15 scores at 48 h were higher in the tegileridine group (median 125 vs 113; P<0.001). Conclusion Among women undergoing cesarean delivery, tegileridine-based PCIA was associated with a lower incidence of PONV and dizziness and improved postoperative recovery quality compared with sufentanil, while postoperative analgesic outcomes were not significantly different between groups. These findings warrant confirmation in larger multicenter studies before routine clinical adoption.