NCT06660680

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2024

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 25, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

October 25, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 28, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

October 28, 2024

Status Verified

October 1, 2024

Enrollment Period

11 months

First QC Date

October 25, 2024

Last Update Submit

October 25, 2024

Conditions

Mixed Hemorrhoids

Keywords

Milligan-Morgan surgery

Outcome Measures

Primary Outcomes (1)

  • Pain

    Visual Analog Scale (VAS) scores

    pain scores at 6, 24, 48, and 72 hours postoperatively

Study Arms (2)

Study Group

EXPERIMENTAL

received MBI treatment to their surgical incisions upon completion of surgery

Drug: Methylene Blue

Control group

NO INTERVENTION

administered lornoxicam on an as-needed basis for analgesia.

Interventions

Methylene BlueDRUG

Received MBI treatment to their surgical incisions upon completion of surgery

Study Group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Second hospital affiliated Anhui University of Chinese Medicine

Hefei, Anhui, 230000, China

Location

Related Publications (1)

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

    BACKGROUND

MeSH Terms

Interventions

Methylene Blue

Intervention Hierarchy (Ancestors)

PhenothiazinesSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
the second Hospital of Chinese Medicine

Study Record Dates

First Submitted

October 25, 2024

First Posted

October 28, 2024

Study Start

October 25, 2024

Primary Completion

October 1, 2025

Study Completion

October 1, 2025

Last Updated

October 28, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)