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NOT YET RECRUITING
NCT07164807
PHASE4

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

Sponsor: The Affiliated Hospital of Putian University

View on ClinicalTrials.gov

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.

Official title: Comparative Efficacy of Varying Concentrations of Methylene Blue Combined With Ropivacaine for Postoperative Analgesia Following Milligan-Morgan Hemorrhoidectomy: A Single-Center, Prospective, Open-Label, Randomized, Parallel-Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

177

Start Date

2025-08-30

Completion Date

2026-12

Last Updated

2025-09-10

Healthy Volunteers

No

Interventions

DRUG

Methylene Blue (0.3%) with Ropivacaine Hydrochloride (0.75%)

Perianal subcutaneous injection of 0.3% methylene blue solution (Formulation: 1.5 mL of 1% methylene blue with 3.5 mL ropivacaine hydrochloride injection).

DRUG

Methylene Blue (0.1%) with Ropivacaine Hydrochloride (0.75%)

Perianal subcutaneous injection of 0.1% methylene blue solution (Formulation: 0.5 mL of 1% methylene blue with 4.5 mL ropivacaine hydrochloride injection).

Locations (1)

Affiliated Hospital of Putian University

Putian, China