The Use of Low Dose Metronidazole to Decrease Postoperative Pain After Endometriosis Surgery: A Prospective, Randomized, Placebo-Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- Self-reported pain persistence
研究概览
简要总结
The purpose of this study is to determine a difference in participant reported pain after endometriosis surgery in participants given oral metronidazole versus placebo.
详细描述
The study is a prospective, randomized, placebo-controlled trial. Women scheduled for endometriosis surgery between 18-50 years of age will be invited to participate in the study.
Participants with surgically staged endometriosis will be randomized to the metronidazole plus routine postoperative care arm or the placebo plus routine postoperative care arm. Participants will take study or placebo drug for a total of 14 days.
Participants will complete surveys at baseline and postoperatively at 6 weeks, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years reporting intensity of endometriosis associated pain on a visual analog scale, pregnancy outcomes, quality of life, and sexual health.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Able to give informed consent
- •Women aged 18-50 years old
- •Scheduled to undergo excision of endometriosis
- •Able to read and write in English and or Spanish
- •Pain score > 2 on a 10 point visual analogue scale at baseline
- •Negative screening by CAGE questionnaire
排除标准
- •Refusal to surgery
- •Contraindication to surgery
- •Known allergy to metronidazole
- •Known allergy to any component in gelatin placebo capsules
- •Scheduled hysterectomy
- •Endometriosis excision surgery within the last 3 months
- •Elevated serum creatinine
- •Abnormal liver function test greater than 2 times the normal
- •Current pregnancy
- •Breastfeeding
- •Use of Disulfiram within the last 2 weeks
- •History of Cockayne syndrome
- •Inability to abstain from alcohol during the use of study drug
研究组 & 干预措施
Placebo
Halal and Kosher certified gelatin placebo capsules
干预措施: Placebo (Drug)
Metronidazole
Metronidazole
干预措施: Metronidazole Oral (Drug)
结局指标
主要结局
Self-reported pain persistence
时间窗: 6 weeks postoperatively.
The outcome of binary, subject pain persistence, assessed as yes or no, will be compared between groups using the Fisher exact test.
次要结局
- Quality of life scores(5 years postoperatively.)
- Sexual health(5 year postoperatively.)
- Self-reported pain persistence(6 months postoperatively.)
研究者
Resad Pasic
Director, Fellowship in Advanced Gynecologic Endoscopy, Department of Obstetrics and Gynecology and Woman's Health, University of Louisville School of Medicine
University of Louisville