Clinical trial Recruiting at 3 sites Observational Ages 18 to 65

Using Methylene Blue to Improve Recovery After Hemorrhoid Surgery

Official title: The Impact of Intradermal Methylene Blue Injection on the Quality of Recovery in Patients Undergoing Hemorrhoidectomy: a Multicenter Prospective Cohort Study

Run by Qilu Hospital of Shandong University · NCT06747195 · Data updated 2026-11-12

This study tests if using Methylene Blue can help people recover better after hemorrhoid surgery by looking at their pain levels and overall well-being.

Quick facts

Study typeObservational
Ages18 Years to 65 Years
SexAll
Enrollment290 (estimated)
SponsorQilu Hospital of Shandong University
Academic / other
Locations3 sites (Heze, Shandong and 2 other locations)
StatusRecruiting
StartedJanuary 1, 2025
Main results expectedMay 31, 2026
Study endsDecember 31, 2026
Registry record updatedFebruary 17, 2025
Trial IDNCT06747195 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 18 to 65 with grade III/IV mixed hemorrhoids undergoing hemorrhoidectomy under spinal anesthesia.

Probably not a fit

Patients with diabetes, mental health issues, or those taking certain medications may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study investigates the effects of Methylene Blue (MB) on the quality of recovery in patients undergoing hemorrhoidectomy. It utilizes the Quality of Recovery (QOR-15) score to objectively measure various aspects of patient recovery, including pain management and overall well-being. The study focuses on patients diagnosed with grade III/IV mixed hemorrhoids who are treated under spinal anesthesia. Previous research has indicated that MB may provide temporary pain relief by disrupting anal sensory nerve terminals, making this an important area of exploration for postoperative care.

Why it matters

Potential benefit: If successful, this study could lead to improved pain management and enhanced recovery experiences for patients undergoing hemorrhoidectomy.

How similar studies have gone: Previous studies in Singapore and China have shown promising results regarding the analgesic effects of Methylene Blue in similar surgical contexts.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Diagnosed with mixed hemorrhoids, grade III/ IV hemorrhoids (Goligher's classification), and underwent hemorrhoidectomy under spinal anesthesia; and
* Aged between 18 and 65 years; and
* ASA I or II.

Exclusion Criteria:

* Patients who experienced any ill-effects from previous use of MB or other medications in the protocol (ketorolac, ropivacaine); or
* Patients with diabetes; or
* Alcohol or other addictive drug dependence; or
* Illiteracy, combined with mental system or severe mental illness that prevented completion of the assessment; or
* Patients who are pregnant or breast-feeding; or
* Aspirin and analgesic drugs taken within 2 weeks before surgery; or
* Patients taking selective serotonin reuptake inhibitors (SSRIs); or
* Concurrent additional anorectal diseases (e.g., perianal abscess, anal fistula, fissures, anal incontinence); or
* Patients who are participating in other clinical trials and have not reached the endpoint.

Where it's running

  • Heze Hospital of Traditional Chinese Medicine
    Heze, Shandong, China
    Recruiting
  • Qilu hospital of Shandong University
    Jinan, Shandong, China
    Recruiting
  • Weifang People's Hospital
    Weifang, Shandong, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.