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

T

The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine

Status and phase

Invitation-only
Phase 3

Conditions

Mixed Hemorrhoids

Treatments

Drug: Methylene Blue

Study type

Interventional

Funder types

Other

Identifiers

NCT06660680
HFBH2021011
(No. 2023AH050848) (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 2 patient groups

Study Group
Experimental group
Description:
received MBI treatment to their surgical incisions upon completion of surgery
Treatment:
Drug: Methylene Blue
Control group
No Intervention group
Description:
administered lornoxicam on an as-needed basis for analgesia.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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