The Ethics Committee of the Second Hospital of Chinese Medicine
试验速览
- 阶段
- 3 期
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Pain
研究概览
简要总结
A variety of analgesic strategies are available following mixed hemorrhoids surgery, including pharmacological interventions (7), acupuncture, moxibustion, and electroacupuncture . Medications such as opioid analgesics and non-steroidal anti-inflammatory drugs (NSAIDs) are commonly used but can be associated with side effects including nausea, vomiting, and gastrointestinal bleeding, with long-term use potentially leading to addiction (8). Complementary therapies require skilled administration and regular treatment sessions.
Methylene blue (MB), a cationic thiazine dye extensively utilized as a biological stain and chemical indicator, has been increasingly recognized for its potential analgesic properties (9). In the present study, methylene blue infiltrating injection (MBI) was administered to treat anal pain resulting from Milligan-Morgan surgery, with the aim of assessing its analgesic efficacy and safety profile.
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
- •①Alignment with the diagnostic criteria for mixed hemorrhoids as outlined in the "American Society of Colon and Rectal Surgeons Clinical Practice Guidelines for the Management of Hemorrhoids" ; ②Provision of informed consent following a thorough comprehension of the study's aims; ③An age bracket of 18 to 75 years; ④Satisfaction of surgical indications.
排除标准
- •①Presence of anal fistula, anal fissure, perianal abscess, enteritis, or other intestinal pathologies; ②Patients with known allergies; ③Impaired liver or kidney function; ④Pregnancy or lactation.
研究组 & 干预措施
Study Group
received MBI treatment to their surgical incisions upon completion of surgery
干预措施: Methylene Blue (Drug)
结局指标
主要结局
Pain
时间窗: pain scores at 6, 24, 48, and 72 hours postoperatively
Visual Analog Scale (VAS) scores
次要结局
未报告次要终点
研究者
Heng Deng
the second Hospital of Chinese Medicine
The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine