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
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 177
- 试验地点
- 1
- 主要终点
- Postoperative Numerical Rating Scale (NRS) Pain Scores
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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).
干预措施: Methylene Blue (0.3%) with Ropivacaine Hydrochloride (0.75%) (Drug)
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).
干预措施: Methylene Blue (0.1%) with Ropivacaine Hydrochloride (0.75%) (Drug)
结局指标
主要结局
Postoperative Numerical Rating Scale (NRS) Pain Scores
时间窗: 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.
Total Postoperative Analgesic Consumption
时间窗: Within 30 days after surgery
Metric: Cumulative dosage of rescue analgesics (e.g., NSAIDs or opioids) administered during the follow-up period.
Postoperative Quality of Life (QoL) Metrics
时间窗: 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).
次要结局
- Incidence of Postoperative Complications(Within 30 days after surgery)