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Not yet recruiting NCT07164807

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

Phase IV Interventional Mixed Hemorrhoids Milligan-Morgan Hemorrhoidectomy Methylene Blue

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Methylene Blue (0.3%) with Ropivacaine Hydrochloride (0.75%), Methylene Blue (0.1%) with Ropivacaine Hydrochloride (0.75%).
Who it may be relevant to
Registry conditions: Mixed Hemorrhoids, Milligan-Morgan Hemorrhoidectomy, Methylene Blue. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official 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

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.

Interventions

  • Drug Methylene 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).
  • Drug Methylene 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).

Primary outcome measures

  • Postoperative Numerical Rating Scale (NRS) Pain Scores [Time frame: Within 30 days after surgery]
  • Total Postoperative Analgesic Consumption [Time frame: Within 30 days after surgery]
  • Postoperative Quality of Life (QoL) Metrics [Time frame: Within 30 days after surgery]
Secondary outcome measures (1)
  • Incidence of Postoperative Complications [Time frame: Within 30 days after surgery]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Affiliated Hospital of Putian University — Putian

Identifiers

NCT: NCT07164807 · AHPuTianU-011

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗