Methylene Blue, Milligan-Morgan Hemorrhoidectomy, Mixed Hemorrhoids
Conditions
Brief summary
Revised Translation (Academic English): As one of the most prevalent anorectal disorders, mixed hemorrhoids continue to rely on the Milligan-Morgan hemorrhoidectomy as the gold-standard surgical approach. While this technique demonstrates well-established efficacy, managing acute postoperative pain-particularly during the critical 24-72-hour peak pain window-remains a persistent clinical challenge. Recent advancements in multimodal analgesia have highlighted the potential of local nerve blockers, with methylene blue (MB) gaining scientific interest due to its prolonged analgesic properties. This randomized controlled study systematically evaluates the synergistic analgesic effects of gradient concentrations of MB combined with ropivacaine (ROP) following Milligan-Morgan procedures. Therapeutic safety profiles were validated through dual-dimensional monitoring of Visual Analog Scale (VAS) scores and complication rates, aiming to establish evidence-based optimal dosing protocols and refine perioperative pain management strategies.
Interventions
DRUGMethylene Blue (0.3%) with Ropivacaine Hydrochloride (0.75%)
Perianal subcutaneous injection of 0.3% methylene blue solution (Formulation: 1.5 mL of 1% methylene blue with 3.5 mL ropivacaine hydrochloride injection).
DRUGMethylene Blue (0.1%) with Ropivacaine Hydrochloride (0.75%)
Perianal subcutaneous injection of 0.1% methylene blue solution (Formulation: 0.5 mL of 1% methylene blue with 4.5 mL ropivacaine hydrochloride injection).
Sponsors
The Affiliated Hospital of Putian University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Aged between 18 and 75 years. 2. Diagnosed with Grade III-IV hemorrhoids according to the Goligher classification. 3. Scheduled to undergo standard Milligan-Morgan hemorrhoidectomy. 4. Procedure performed under spinal anesthesia alone.
Exclusion criteria
1. Pregnancy or lactation. 2. Current immunotherapy or coagulopathies. 3. Contraindications to any protocol-specified agents (e.g., history of severe allergic reactions to methylene blue or ropivacaine). 4. Concurrent anorectal pathologies (e.g., perianal abscess, anal fistula, fecal incontinence). 5. Comorbid systemic conditions (e.g., cardiac/hepatic/renal insufficiency, diabetes mellitus, coagulopathy, peptic ulcer disease). 6. Incomplete perioperative documentation. 7. Inability to comply with follow-up protocols.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Numerical Rating Scale (NRS) Pain Scores | Within 30 days after surgery | Assessment timepoints: At postoperative days 1, 2, 3, 4, 5days, 2 weeks, and 1 month.0 usually means no pain.10 means the worst pain imaginable. |
| Total Postoperative Analgesic Consumption | Within 30 days after surgery | Metric: Cumulative dosage of rescue analgesics (e.g., NSAIDs or opioids) administered during the follow-up period. |
| Postoperative Quality of Life (QoL) Metrics | Within 30 days after surgery | Postoperative QoL metrics are standardized tools (questionnaires, surveys) used to measure a patient's overall well-being and functional status after a surgical procedure.patients rate their overall health from 0 (worst) to 100 (best). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Postoperative Complications | Within 30 days after surgery | Documented adverse events:urinary retention,secondary hemorrhage,perianal edema,secondary infection,pruritus and other procedure-related morbidities. |
Countries
China
Contacts
Primary ContactChenxing Jian, MD.,PHD.
Outcome results
None listed