Efficacy and safety of oliceridine versus sufentanil for patient-controlled intravenous analgesia following gynecological laparoscopic surgery: a randomized, double-blind, parallel-group trial
Background To compare the efficacy and incidence of adverse reactions of oliceridine versus sufentanil in patient-controlled intravenous analgesia (PCIA) for postoperative pain management following gynecological laparoscopic surgery. Methods In this randomized, double-blind trial, 152 patients undergoing elective gynecological laparoscopic surgery were randomly assigned to receive PCIA with either oliceridine (Group O, 0.4 mg/kg, n = 76) or sufentanil (Group S, 2 μg/kg, n = 76). The primary outcome was the Visual Analog Scale (VAS) score at rest at 2, 4, 8, 12, 18, 24, 36, and 48 h postoperatively. Secondary outcomes included postoperative Mini-Mental State Examination (MMSE) scores, number of PCIA demands, rescue analgesic use, adverse events, time to first flatus and defecation, patient satisfaction, and length of hospital stay. Results Resting VAS scores were comparable between groups except at 4 h (p < 0.05). No significant differences were observed in MMSE scores, PCIA demands, rescue analgesia, time to first defecation, or other adverse events (pruritus, dizziness, fever, headache, cough, and abdominal distension) (all p > 0.05). Group O had higher body weight and body mass index (BMI) than Group S (p = 0.028 and p = 0.041, respectively). Group O demonstrated lower postoperative nausea and vomiting (PONV) incidence (19.48% vs. 36.14%; relative risk (RR), 0.54; 95% confidence interval (CI), 0.32–0.92; p = 0.019), prolonged time to first flatus (27.16 ± 9.33 h vs. 23.23 ± 9.36 h; p = 0.014), and higher patient satisfaction (4.09 ± 0.81 vs. 3.74 ± 0.72; p = 0.006). Conclusion For postoperative analgesia following gynecological laparoscopic surgery, oliceridine provides effective analgesia comparable to sufentanil while significantly reducing the risk of opioid-related PONV, demonstrating a favorable safety profile. Clinical trial registration http://www.chictr.org.cn/, ChiCTR2400089648.