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NCT Number: NCT07164807

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

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.

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Key information

Conditions

Mixed Hemorrhoids Methylene Blue Milligan-Morgan Hemorrhoidectomy

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Affiliated Hospital of Putian University

Putian, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged between 18 and 75 years.
  • Diagnosed with Grade III-IV hemorrhoids according to the Goligher classification.
  • Scheduled to undergo standard Milligan-Morgan hemorrhoidectomy.
  • Procedure performed under spinal anesthesia alone.

Exclusion criteria

  • Pregnancy or lactation.
  • Current immunotherapy or coagulopathies.
  • Contraindications to any protocol-specified agents (e.g., history of severe allergic reactions to methylene blue or ropivacaine).
  • Concurrent anorectal pathologies (e.g., perianal abscess, anal fistula, fecal incontinence).
  • Comorbid systemic conditions (e.g., cardiac/hepatic/renal insufficiency, diabetes mellitus, coagulopathy, peptic ulcer disease).
  • Incomplete perioperative documentation.
  • Inability to comply with follow-up protocols.

Treatment and study plan

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).

Primary outcomes

  1. Postoperative Numerical Rating Scale (NRS) Pain Scores

    Time frame: 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.

  2. Total Postoperative Analgesic Consumption

    Time frame: Within 30 days after surgery

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

  3. Postoperative Quality of Life (QoL) Metrics

    Time frame: 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 outcomes

  1. Incidence of Postoperative Complications

    Time frame: Within 30 days after surgery

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

Study contacts

Contact information is provided by the study sponsor or research team.

Chenxing Jian, MD.,PHD.

CONTACT

[email protected]

+86-13959538950

Sponsors and collaborators

Lead sponsor

The Affiliated Hospital of Putian University

Other

Registry information

Official study title

Comparative Efficacy of Varying Concentrations of Methylene Blue Combined With Ropivacaine for Postoperative Analgesia Following Milligan-Morgan Hemorrhoidectomy: A Single-Center, Prospective, Open-Label, Randomized, Parallel-Controlled Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 10, 2025
Registry last updated
Sep 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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