Efficacy of Methylene Blue Plus Ropivacaine for Post-Hemorrhoidectomy Pain.

Phase 4Not Yet RecruitingNCT07164807

The Affiliated Hospital of Putian University177 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

177

Conditions

Mixed Hemorrhoids Milligan-Morgan Hemorrhoidectomy Methylene Blue

Interventions

Methylene Blue (0.3%) with Ropivacaine Hydrochloride (0.75%)DRUG

Perianal subcutaneous injection of 0.3% methylene blue solution (Formulation: 1.5 mL of 1% methylene blue with 3.5 mL ropivacaine hydrochloride injection).

Methylene Blue (0.1%) with Ropivacaine Hydrochloride (0.75%)DRUG

Perianal subcutaneous injection of 0.1% methylene blue solution (Formulation: 0.5 mL of 1% methylene blue with 4.5 mL ropivacaine hydrochloride injection).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Postoperative Numerical Rating Scale (NRS) Pain Scores

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.

Time frame: Within 30 days after surgery

Total Postoperative Analgesic Consumption

Metric: Cumulative dosage of rescue analgesics (e.g., NSAIDs or opioids) administered during the follow-up period.

Time frame: Within 30 days after surgery

Postoperative Quality of Life (QoL) Metrics

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).

Time frame: Within 30 days after surgery

Secondary Outcomes

Incidence of Postoperative Complications

Documented adverse events:urinary retention,secondary hemorrhage,perianal edema,secondary infection,pruritus and other procedure-related morbidities.

Time frame: Within 30 days after surgery

Efficacy of Methylene Blue Plus Ropivacaine for Post-Hemorrhoidectomy Pain.

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts