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The Impact of Methylene Blue on the Quality of Recovery in Patients Undergoing Hemorrhoidectomy

Recruitingn/aAges 18 Years - 65 YearsAllQilu Hospital of Shandong University
NCT06747195 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Classical hemorrhoidectomy is known to be linked with significant postoperative pain, which can result in patient discomfort, extended hospital stays, and increased costs. The Quality of Recovery (QOR) score serves as an objective measure of patient-centered general health status following surgery and anesthesia. The latest version, QOR-15, is known for its time-efficiency, high rate of response, and completion, and has been validated in patients undergoing a range of surgical procedures. Methylene blue (MB) is a water-soluble thiazine dye used to treat various conditions and has been found to have a unique analgesic property through the temporary disruption of anal sensory nerve terminals in patients. Studies conducted in Singapore and China have shown that perianal intradermal injection of MB provides temporary pain relief after hemorrhoidectomy and lateral anal sphincterotomy. Howeve

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📋 Eligibility rules (as published)
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.
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What it tests

  • Not listed
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Where

3 sites
Heze Hospital of Traditional Chinese Medicine
Heze, China
Qilu hospital of Shandong University
Jinan, China
Weifang People's Hospital
Weifang, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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