Trial reportPloS one2026
Efficacy of different doses of oliceridine for Patient-Controlled Intravenous Analgesia in patients undergoing Total Laparoscopic Hysterectomy.
Trial report in PloS one, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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7 authors.
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Abstract
objectiveTo evaluate the efficacy and safety of three oliceridine different doses for oliceridine for patient-controlled analgesia (PCIA) in patients undergoing during total laparoscopic hysterectomy, following the premature termination of the planned sufentanil control arm.
methodsThis prospective, randomized, double-blind trial was originally designed as a four-arm study. Due to operational challenges in patient recruitment and randomization within the single-center setting-specifically, significant reluctance among eligible patients to be randomized to receive a traditional opioid regimen when oliceridine was available, leading to unsustainable enrollment timelines-the sufentanil control arm was prematurely terminated. The final analysis therefore focused on three oliceridine doses: 0.1, 0.35, and 0.5 mg/kg, diluted to 100 ml with normal saline for 48-hour PCIA. The primary endpoint for sample size calculation was the incidence of postoperative nausea and vomiting (PONV) at 24 h. Efficacy and safety outcomes analyzed included: NRS pain scores (at rest and during cough), Ramsay sedation scores, incidence of rescue analgesia, various recovery indicators (time to first flatus, time to ambulation, QoR-15 scores), and opioid-related adverse events.
resultsCompared to the low-dose group, the moderate- and high-dose groups demonstrated significant improvements in cough-pain scores and bolus press attempts ("Bolus press attempts" were defined as the total number of patient-initiated demands for a supplemental dose, including attempts made within the lockout interval) (p < 0.0083). Further comparison revealed that the moderate-dose group showed the best recovery outcomes, including shorter time to first flatus and ambulation, and higher QoR-15 scores. In contrast, although the high-dose group provided more potent analgesia, it was associated with a higher incidence of nausea, delayed flatus, and a significantly lower quality of recovery (QoR-15) score at 48 hours postoperatively compared to the moderate-dose group (p < 0.0083).
conclusionWithin the investigated PCA oliceridine dose range, the 0.35 mg/kg dose promotes early recovery in patients undergoing laparoscopic total hysterectomy through effective analgesia and reduced nausea, representing the best balance between efficacy and safety among the tested oliceridine-specific regimens.
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