Effect of intravenous lidocaine on nociception level‐directed management in robot‐assisted laparoscopic radical prostatectomy: protocol for a single‐centre, factorial‐randomised controlled trial ( <scp>VALINOR</scp> study)

摘要

Study Objective: ¹) during robot-assisted radical prostatectomy. Design: Single-centre, double-blinded, two-by-two factorial randomised controlled trial. Setting: Operating theatres at Nara Medical University Hospital, Nara, Japan. Participants: Eighty-four adult patients scheduled for elective robot-assisted radical prostatectomy were participated in the study. Interventions: Participants will be randomised into four groups (lidocaine/0.11, lidocaine/0.05, placebo/0.11 and placebo/0.05). All groups will receive nociception level-guided intra-operative opioid management. Measurements: The primary outcome is the numerical rating scale score during movement 2 hours after surgery. Secondary outcomes include plasma concentrations of peri-operative inflammatory biomarkers (interleukin-6, cortisol and C-reactive protein), intra-operative remifentanil consumption, Quality of Recovery-15 scores (pre-operative and postoperative days 1 and 2), postoperative numerical rating scale scores up to postoperative day 7, peri-operative fentanyl consumption and the presence of prolonged postoperative pain at 3 months. Hypothesis: Lidocaine will decrease intra-operative remifentanil requirements and early postoperative pain without increasing the inflammatory biomarker levels and the minimum remifentanil infusion rate limit will not significantly impact clinical outcomes. Conclusion: This trial will evaluate the effects of intra-operative lidocaine administration and minimum remifentanil infusion rate limit based on nociception level-guided opioid management in patients undergoing robot-assisted radical prostatectomy. Trial Registration: Japan Registry of Clinical Trials, jRCTs052240226 (registered on 26 December 2024, https://jrct.mhlw.go.jp/latest-detail/jRCTs052240226). Ethics Approval: This protocol was approved by the Certified Review Board of Nara Medical University on 11 December 2024 (nara0063). Study Period: Recruitment is planned from January 2025 to December 2026, with final follow-up completed in March 2027.