Cutaneous Sensory Function After Wound Instillation of Capsaicin During Groin Hernia Repair
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- changes in sensory function before and 2 years after groin hernia repair in patients with and without capsaicin instillation, evaluated by quantitative sensory testing
研究概览
简要总结
The use of capsaicin as a potential analgesic drug for postoperative pain relies on the ability of capsaicin to induce membrane lysis of c-nerve fibers. In a previous randomized placebo controled blinded study of this effect we found a significant effect of capsaicin versus placebo. Before surgery all patients were examined by quantitative sensory testing to evaluate sensory function. In this study an identical sensory testing will examine if changes to the sensory function in capsaicin treated patients is identical to placebo treated patients.No new intervention will be performed
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Primary groin hernia planned to undergo Lichtenstein mesh repair
- •Ability to use pain scales
- •American Society of Anesthesiologist class I or II based upon medical history, physical examination, and screening laboratory results
- •Willing to take oral pain medication (acetaminophen, ibuprofen) for the first week
- •Willing to fill out a diary for four weeks following surgery.
排除标准
- •A previous lower abdominal surgical procedure
- •Bupivacaine, acetaminophen, ibuprofen, or tramadol
- •A medical condition likely to alter wound healing or pain ratings
- •Systolic blood pressure greater than 150 or diastolic greater than 95 mm Hg
- •Contraindication to general anesthesia
- •Bilateral hernia repair
- •A history of drug or alcohol abuse within the past two years
- •Use of antihypertensive, antidepressant, or psychotropic drug that has not been stable for 3 months
- •Use of an investigational drug within 3 months or scheduled to receive an investigational drug other than ALGRX 4975 during the study period.
研究组 & 干预措施
A
Capsaicin treated patients
干预措施: Capsaicin (Drug)
结局指标
主要结局
changes in sensory function before and 2 years after groin hernia repair in patients with and without capsaicin instillation, evaluated by quantitative sensory testing
时间窗: 2 years
次要结局
- Frequency of chronic pain(2 years)