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Opioid-free versus opioid-based anesthesia for robot-assisted radical prostatectomy: a single-center randomized controlled trial

In brief

Opioid-free anesthesia lowers 24-hour oxycodone use by 6 mg after robotic prostatectomy

In this single-center randomized trial of 149 men, opioid-free anesthesia reduced estimated 24-hour oxycodone use by 6 mg compared with remifentanil-based anesthesia, with median use of 12 versus 19 mg. Pain scores and reported safety outcomes were similar, so the reduction in opioid use did not translate into better pain scores; whether it holds beyond this standardized care setting remains unknown.

Journal
Journal of robotic surgery (Q1)
Published
13 October 2026
Study design
Randomized controlled trial
Evidence level
Level 1, High (CEBM 1b)
Authors
Tomasz Składzień, Aleksandra Żmuda, Michał Cicio, Teresa Kowal, Anna Kwinta, Renata Bugielska, et al.
PMID
42867736
DOI
10.1007/s11701-026-04028-7

Why clinicians should know about it

Abstract

Multimodal, opioid-sparing analgesia is standard in urological surgery, and there is additional interest in eliminating intraoperative opioids in prostate cancer surgery. Randomized evidence for opioid-free anesthesia (OFA) in robot-assisted radical prostatectomy (RARP) is lacking. In this single-center randomized controlled trial, adult men undergoing RARP were allocated 1:1 to OFA (dexmedetomidine plus ketamine, no intraoperative opioids) or a remifentanil-based technique. Both groups received identical multimodal premedication, a bilateral quadratus lumborum block, sevoflurane maintenance and identical oxycodone patient-controlled analgesia (PCA). The primary outcome was cumulative PCA oxycodone consumption over the first 24 postoperative hours. Prespecified secondary outcomes were pain (NRS), postoperative nausea and vomiting (PONV), the demanded-to-delivered PCA bolus ratio, and perioperative changes in serum creatinine and white-cell count. A total of 149 patients were analyzed (OFA n=75, opioid-based n=74). Cumulative 24-h oxycodone consumption was lower with OFA (median 12.0 mg [interquartile range, IQR 6.0-22.0] vs 19.0 mg [10.5-34.0]; p=0.001), with a Hodges-Lehmann location-shift estimate of -6.0 mg (95% confidence interval, CI -10.0 to -2.0). Pain scores did not differ at any time point, and PONV was infrequent, with no significant between-group difference. Intraoperative hemodynamic adverse events (bradycardia, hypotension), perioperative white-cell count and serum creatinine did not differ between groups. In RARP delivered on a standardized multimodal and regional analgesic background, OFA reduced postoperative opioid consumption compared with a remifentanil-based technique, without a detectable difference in pain scores and with a similar safety profile.Trial registration ClinicalTrials.gov NCT06380244, registered 23 April 2024.

Abstract as published, via PubMed.

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For healthcare professionals. The summary is generated by AI from the published abstract, and the evidence level is assigned automatically from the study design on the Oxford CEBM hierarchy. Neither is medical advice. Read the full paper before changing practice.