NCT07164807

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

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

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 177 (estimated)
• Sponsor: The Affiliated Hospital of Putian University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Mixed Hemorrhoids
• Milligan-Morgan Hemorrhoidectomy
• Methylene Blue

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2025-08-30
• Primary completion: 2026-08-01
• Completion: 2026-12-01
• First posted: 2025-09-10
• Last updated: 2025-09-10

Locations

1 site across 1 country: China