The Effect of Methylene Blue Infiltrating Injection on Anal Pain After Milligan-Morgan Surgery: a Randomized Controlled Clinical Study

Phase 3

• Conditions: Mixed Hemorrhoids
• Interventions: Drug: Methylene Blue

• Registration Number: NCT06660680
• Lead Sponsor: The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine

Brief Summary

A variety of analgesic strategies are available following mixed hemorrhoids surgery, including pharmacological interventions (7), acupuncture, moxibustion, and electroacupuncture . Medications such as opioid analgesics and non-steroidal anti-inflammatory drugs (NSAIDs) are commonly used but can be associated with side effects including nausea, vomiting, and gastrointestinal bleeding, with long-term use potentially leading to addiction (8). Complementary therapies require skilled administration and regular treatment sessions.

Methylene blue (MB), a cationic thiazine dye extensively utilized as a biological stain and chemical indicator, has been increasingly recognized for its potential analgesic properties (9). In the present study, methylene blue infiltrating injection (MBI) was administered to treat anal pain resulting from Milligan-Morgan surgery, with the aim of assessing its analgesic efficacy and safety profile.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-10
• Study Start: 2024-10-25
• Study First Submitted: 2024-10-25
• Study First Submitted QC: 2024-10-25
• Last Update Submitted: 2024-10-25
• Study First Posted: 2024-10-28
• Last Update Posted: 2024-10-28
• Primary Completion: 2025-10-01
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

①Alignment with the diagnostic criteria for mixed hemorrhoids as outlined in the "American Society of Colon and Rectal Surgeons Clinical Practice Guidelines for the Management of Hemorrhoids" ; ②Provision of informed consent following a thorough comprehension of the study's aims; ③An age bracket of 18 to 75 years; ④Satisfaction of surgical indications.

Exclusion Criteria

①Presence of anal fistula, anal fissure, perianal abscess, enteritis, or other intestinal pathologies; ②Patients with known allergies; ③Impaired liver or kidney function; ④Pregnancy or lactation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study Group	Methylene Blue	received MBI treatment to their surgical incisions upon completion of surgery

Primary Outcome Measures

Name	Time	Method
Pain	pain scores at 6, 24, 48, and 72 hours postoperatively	Visual Analog Scale (VAS) scores

Trial Locations

Locations (1)

Second hospital affiliated Anhui University of Chinese Medicine; 🇨🇳 Hefei, Anhui, China