Using Methylene Blue to Improve Recovery After Hemorrhoid Surgery
The Impact of Intradermal Methylene Blue Injection on the Quality of Recovery in Patients Undergoing Hemorrhoidectomy: a Multicenter Prospective Cohort Study
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 |
|---|---|
| Enrollment | 290 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Qilu Hospital of Shandong University Academic / other |
| Locations | 3 sites (Heze, Shandong and 2 other locations) |
| Trial ID | NCT06747195 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 with grade III/IV mixed hemorrhoids undergoing hemorrhoidectomy under spinal anesthesia.
Not a fit: Patients with diabetes, mental health issues, or those taking certain medications may not benefit from this study.
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 performed: Previous studies in Singapore and China have shown promising results regarding the analgesic effects of Methylene Blue in similar surgical contexts.
Eligibility criteria
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 this trial is running
Heze, Shandong and 2 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.