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 type | Observational |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 290 (estimated) |
| Sponsor | Qilu Hospital of Shandong University Academic / other |
| Locations | 3 sites (Heze, Shandong and 2 other locations) |
| Status | Recruiting |
| Started | January 1, 2025 |
| Main results expected | May 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | February 17, 2025 |
| Trial ID | NCT06747195 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
- Study coordinator: Liang Li, MD
- Email: liliang675@126.com
- Phone: +8618560083822
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.