Trial reportDrug design, development and therapy2026
Feedback-Regulated versus Constant-Rate Sufentanil Patient-Controlled Analgesia for Postoperative Nausea and Vomiting After Laparoscopic Myomectomy: A Randomized Controlled Trial.
Trial report in Drug design, development and therapy, 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
Background: Postoperative nausea and vomiting (PONV) remains a common and distressing side effect of opioid-based patient-controlled analgesia (PCA). Although continuous background infusion stabilizes analgesia, it often induces excessive opioid exposure and related adverse events. This study evaluates a novel smart PCA system featuring feedback-regulated background infusion (FRBI) designed to dynamically adjust opioid delivery based on real-time pain feedback, aiming to reduce PONV without compromising analgesia. Methods: In this prospective, randomized, controlled, single-center trial, 132 patients undergoing laparoscopic myomectomy were assigned in a 1:1 parallel-group design to either constant-rate background infusion (CRBI) at 2 mL/h (Group A) or FRBI with adjustable rates of 1-4 mL/h (Group B). Both groups received a standardized sufentanil-flurbiprofen solution via PCA. The FRBI algorithm dynamically adjusted the infusion rate: a 20% increase was triggered by ≥2 bolus demands within 30 minutes, and a 20% decrease followed 4 consecutive demand-free hours. The primary outcome was the incidence of PONV (defined as nausea and/or vomiting) within 48 hours postoperatively. Secondary outcomes included pain scores (NRS), total opioid consumption, occurrence of other adverse events, and patient satisfaction. Results: The FRBI group demonstrated a significantly lower incidence of PONV (nausea and/or vomiting) compared to the CRBI group (41.7% vs 62.7%, risk difference: -21.0% [95% CI: -38.1% to -3.9%]; risk ratio: 0.66 [95% CI: 0.46 to 0.96], P = 0.022). Total sufentanil consumption was reduced by approximately 30% in the FRBI group (P < 0.01). Pain scores were comparable between groups at all time points. Patient satisfaction was significantly higher in the FRBI group (P < 0.01). No cases of respiratory depression were observed in either group. Conclusion: The feedback-regulated background infusion mode significantly reduces the incidence of PONV and total opioid consumption while maintaining effective analgesia in patients undergoing laparoscopic myomectomy. This strategy suggests a favorable safety profile in this specific surgical population and may represent a promising strategy for opioid-sparing analgesia. Further studies are needed to validate these findings in broader patient populations and to assess economic feasibility.
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