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Trial · Interventional

Enrolling by invitationPhase 3Registry data

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

Short name MBI

NCTNCT06660680 (opens ClinicalTrials.gov in a new tab)Other idHFBH2021011Other id(No. 2023AH050848)
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Enrolling by invitation
Phase
Phase 3
Enrollment
60 participants (estimated)
Sponsor
The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine · Other
Design
Randomized · Open label (no masking)
Countries
1 country

China

Start
25 Oct 2024
Primary completion
1 Oct 2025 (estimated)
Completion
1 Oct 2025 (estimated)
First posted
28 Oct 2024
Last update posted
28 Oct 2024
Conditions
Mixed Hemorrhoids

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202420252026
  1. Ph 3

    MBI

    NCT06660680

    25 Oct 2024 to est. 1 Oct 2025

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

  • Methylene BlueDrug

Arms2

  • Experimental

    Study Group

    received MBI treatment to their surgical incisions upon completion of surgery

  • No intervention

    Control group

    administered lornoxicam on an as-needed basis for analgesia.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Pain

    Time frame · pain scores at 6, 24, 48, and 72 hours postoperatively

    Registry description

    Visual Analog Scale (VAS) scores

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

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

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 75 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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. \-

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