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Enrolling by invitation NCT06660680

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

Phase III Interventional Mixed Hemorrhoids

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Methylene Blue.
Who it may be relevant to
Registry conditions: Mixed Hemorrhoids. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

the Ethics Committee of the Second Hospital of Chinese Medicine

Overview

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.

Interventions

  • Drug Methylene Blue
    Received MBI treatment to their surgical incisions upon completion of surgery

Primary outcome measures

  • Pain [Time frame: pain scores at 6, 24, 48, and 72 hours postoperatively]

Eligibility criteria

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.

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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.

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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Second hospital affiliated Anhui University of Chinese Medicine — Hefei

Publications

  • Anorectal Branch of Chinese Medical Doctor A, Colorectal Surgery Group SSoCMA.

Identifiers

NCT: NCT06660680 · HFBH2021011 · (No. 2023AH050848)

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗