drugset / Trial / NCT07164807

Efficacy of Methylene Blue Plus Ropivacaine for Post-Hemorrhoidectomy Pain.

NCT07164807

Phase 4 Not yet recruiting 177 enrolled The Affiliated Hospital of Putian University
RandomizedParallel-groupOpen-labelTreatment

Summary

Revised Translation (Academic English): As one of the most prevalent anorectal disorders, mixed hemorrhoids continue to rely on the Milligan-Morgan hemorrhoidectomy as the gold-standard surgical approach. While this technique demonstrates well-established efficacy, managing acute postoperative pain-particularly during the critical 24-72-hour peak pain window-remains a persistent clinical challenge. Recent advancements in multimodal analgesia have highlighted the potential of local nerve blockers, with methylene blue (MB) gaining scientific interest due to its prolonged analgesic properties. This randomized controlled study systematically evaluates the synergistic analgesic effects of gradient concentrations of MB combined with ropivacaine (ROP) following Milligan-Morgan procedures. Therapeutic safety profiles were validated through dual-dimensional monitoring of Visual Analog Scale (VAS) scores and complication rates, aiming to establish evidence-based optimal dosing protocols and refine perioperative pain management strategies.

Timeline

Start
2025-08-30
Primary completion
2026-08
Completion
2026-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Methylene Blue Diagnostic / imaging agent 0.1 % Subcutaneous
Subject Methylene Blue Diagnostic / imaging agent 0.3 % Subcutaneous
Background Ropivacaine Other / unclassified 0.75 % Subcutaneous

Indications