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

NCT ID: NCT06660680

Last Updated: 2024-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-25

Study Completion Date

2025-10-01

Brief Summary

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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

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Conditions

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Mixed Hemorrhoids

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Study Group

received MBI treatment to their surgical incisions upon completion of surgery

Group Type EXPERIMENTAL

Methylene Blue

Intervention Type DRUG

Received MBI treatment to their surgical incisions upon completion of surgery

Control group

administered lornoxicam on an as-needed basis for analgesia.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Methylene Blue

Received MBI treatment to their surgical incisions upon completion of surgery

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

\-

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine

OTHER

Sponsor Role lead

Responsible Party

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Heng Deng

the second Hospital of Chinese Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Second hospital affiliated Anhui University of Chinese Medicine

Hefei, Anhui, China

Site Status

Countries

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China

References

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

Reference Type BACKGROUND

Other Identifiers

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(No. 2023AH050848)

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

HFBH2021011

Identifier Type: -

Identifier Source: org_study_id

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