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

NCTNCT07164807Other idAHPuTianU-011

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Overview

Status: Not yet recruiting
Phase: Phase 4
Enrollment: 177 participants (estimated)
Sponsor: The Affiliated Hospital of Putian University · Other
Design: Randomized · Open label (no masking)
Countries: 1 country
China
Start: 30 Aug 2025 (estimated)
Primary completion: Aug 2026 (estimated)
Completion: Dec 2026 (estimated)
First posted: 10 Sept 2025
Last update posted: 10 Sept 2025
Conditions: Mixed Hemorrhoids · Milligan-Morgan Hemorrhoidectomy · Methylene Blue

Timeline

1 trial · 1 not yet recruiting

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

202520262027

Ph 4
Efficacy of Methylene Blue Plus Ropivacaine for Post-Hemorrhoidectomy Pain.
NCT07164807
est. 30 Aug 2025 to est. Dec 2026

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Methylene Blue (0.3%) with Ropivacaine Hydrochloride (0.75%)Drug
Methylene Blue (0.1%) with Ropivacaine Hydrochloride (0.75%)Drug

Arms3

Experimental
High-Concentration Methylene Blue with Ropivacaine Group
Intervention: Perianal subcutaneous injection of 0.1% methylene blue solution (Formulation: 0.5 mL of 1% methylene blue with 4.5 mL ropivacaine hydrochloride injection).
Experimental
Low-Concentration Methylene Blue with Ropivacaine
Intervention: Perianal subcutaneous injection of 0.3% methylene blue solution (Formulation: 1.5 mL of 1% methylene blue with 3.5 mL ropivacaine hydrochloride injection).
No intervention
Ropivacaine hydrochloride injection Group
Postoperative protocol: No routine preemptive analgesia administered.

Primary outcomes3

Outcomes the sponsor listed as primary.

Postoperative Numerical Rating Scale (NRS) Pain Scores
Time frame · Within 30 days after surgery
Registry description
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
Time frame · Within 30 days after surgery
Registry description
Metric: Cumulative dosage of rescue analgesics (e.g., NSAIDs or opioids) administered during the follow-up period.
Postoperative Quality of Life (QoL) Metrics
Time frame · Within 30 days after surgery
Registry description
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 outcomes(1)

Incidence of Postoperative Complications
Time frame · Within 30 days after surgery
Registry description
Documented adverse events:urinary retention,secondary hemorrhage,perianal edema,secondary infection,pruritus and other procedure-related morbidities.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 75 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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.

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