Efficacy of Methylene Blue Plus Ropivacaine for Post-Hemorrhoidectomy Pain.
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-75
SponsorThe Affiliated Hospital of Putian University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Methylene Blue (0.3%) with Ropivacaine Hydrochloride (0.75%)
DrugPerianal 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%)
DrugPerianal subcutaneous injection of 0.1% methylene blue solution (Formulation: 0.5 mL of 1% methylene blue with 4.5 mL ropivacaine hydrochloride injection).
Treatment groups
177 Participants
are divided into 3 treatment groupsGroup A: High-Concentration Methylene Blue with Ropivacaine GroupExperimental treatment 1 intervention
Group B: Low-Concentration Methylene Blue with RopivacaineExperimental treatment 1 intervention
Group C: Ropivacaine hydrochloride injection GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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 surgery2
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 surgery3
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 surgerySecondary outcomes
1
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 surgerySponsors and contacts
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Source ClinicalTrials.gov
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