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

NCT ID: NCT07164807

Last Updated: 2025-09-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 177 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-30
• Study Completion Date: 2026-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

High-Concentration Methylene Blue with Ropivacaine Group

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).

Group Type: EXPERIMENTAL

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

Intervention Type: 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).

Low-Concentration Methylene Blue with Ropivacaine

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).

Group Type: EXPERIMENTAL

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

Intervention Type: 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).

Ropivacaine hydrochloride injection Group

Postoperative protocol: No routine preemptive analgesia administered.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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).

Intervention Type: 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).

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Aged between 18 and 75 years.

2. Diagnosed with Grade III-IV hemorrhoids according to the Goligher classification.

3. Scheduled to undergo standard Milligan-Morgan hemorrhoidectomy.

4. Procedure performed under spinal anesthesia alone.

Exclusion Criteria

1. Pregnancy or lactation.

2. Current immunotherapy or coagulopathies.

3. Contraindications to any protocol-specified agents (e.g., history of severe allergic reactions to methylene blue or ropivacaine).

4. Concurrent anorectal pathologies (e.g., perianal abscess, anal fistula, fecal incontinence).

5. Comorbid systemic conditions (e.g., cardiac/hepatic/renal insufficiency, diabetes mellitus, coagulopathy, peptic ulcer disease).

6. Incomplete perioperative documentation.

7. Inability to comply with follow-up protocols.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Affiliated Hospital of Putian University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Affiliated Hospital of Putian University

Putian, , China

Countries

China

Central Contacts

Chenxing Jian, MD.,PHD.

Role: CONTACT

ptyyjcx@126.com

+86-13959538950

Other Identifiers

AHPuTianU-011

Identifier Type: -

Identifier Source: org_study_id