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

NCT07164807 | Not Yet Recruiting Phase 4

• 1 other identifier: AHPuTianU-011
• Study Type: interventional
• Target: 177
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (3)

• Postoperative Numerical Rating Scale (NRS) Pain Scores

  Assessment timepoints: At postoperative days 1, 2, 3, 4, 5days, 2 weeks, and 1 month.0 usually means "no pain."10 means "the worst pain imaginable.

  Within 30 days after surgery

• Total Postoperative Analgesic Consumption

  Metric: Cumulative dosage of rescue analgesics (e.g., NSAIDs or opioids) administered during the follow-up period.

  Within 30 days after surgery

• Postoperative Quality of Life (QoL) Metrics

  Postoperative QoL metrics are standardized tools (questionnaires, surveys) used to measure a patient's overall well-being and functional status after a surgical procedure.patients rate their overall health from 0 (worst) to 100 (best).

  Within 30 days after surgery

Secondary Outcomes (1)

• Incidence of Postoperative Complications

  Within 30 days after surgery

Study Arms (3)

High-Concentration Methylene Blue with Ropivacaine Group

EXPERIMENTAL

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

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

Low-Concentration Methylene Blue with Ropivacaine

EXPERIMENTAL

Intervention: 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%)

Ropivacaine hydrochloride injection Group

NO INTERVENTION

Postoperative protocol: No routine preemptive analgesia administered.

Interventions

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

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

High-Concentration Methylene Blue with Ropivacaine Group

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

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

Low-Concentration Methylene Blue with Ropivacaine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged between 18 and 75 years.
• Diagnosed with Grade III-IV hemorrhoids according to the Goligher classification.
• Scheduled to undergo standard Milligan-Morgan hemorrhoidectomy.
• Procedure performed under spinal anesthesia alone.

You may not qualify if:

• Pregnancy or lactation.
• Current immunotherapy or coagulopathies.
• Contraindications to any protocol-specified agents (e.g., history of severe allergic reactions to methylene blue or ropivacaine).
• Concurrent anorectal pathologies (e.g., perianal abscess, anal fistula, fecal incontinence).
• Comorbid systemic conditions (e.g., cardiac/hepatic/renal insufficiency, diabetes mellitus, coagulopathy, peptic ulcer disease).
• Incomplete perioperative documentation.
• Inability to comply with follow-up protocols.

Sponsors & Collaborators

• The Affiliated Hospital of Putian University: lead

Study Sites (1)

Affiliated Hospital of Putian University

Putian, China

Location

MeSH Terms

Interventions

Methylene Blue; Ropivacaine

Intervention Hierarchy (Ancestors)

Phenothiazines; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Anilides; Amides; Aniline Compounds; Amines

Central Study Contacts

Chenxing Jian, MD.,PHD.

CONTACT

+86-13959538950; ptyyjcx@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2025
• First Posted: September 10, 2025
• Study Start: August 30, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 10, 2025

Record last verified: 2025-09

Locations

CN (1)