Impact of Placement of a Diazepam Suppository Intraoperatively on Early Postoperative Pain Following Pelvic Reconstructive Surgery: a Double-Blind, Randomized Placebo-Controlled Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Vaginal/Rectal pain in Visual Analogue Scale (VAS) score
研究概览
简要总结
This is a randomized double-blinded placebo controlled trial to examine the use of rectal diazepam suppositories after major vaginal pelvic organ prolapse surgery will decrease postoperative pain in the interval between 3.5 and 6 hours postoperative compared to placebo.
详细描述
Hysterectomy is the most common major surgery performed in gynecology. Minimally invasive techniques for hysterectomy including vaginal and laparoscopic routes are preferred over the more invasive abdominal procedures, which are associated with more pain, longer hospital stays, and increased rates of complications.
Research has continued to provide evidence that same day discharge (SDD) after hysterectomy is safe, cost effective, and well received by patients. Pain is a common concern for patients undergoing major pelvic surgery and pain must be well controlled prior to discharge home.
Rectal administrations of medications are an attractive option postoperatively in patients desiring SDD. Rectal analgesia avoids 1st pass metabolism in the liver, leading to increased bioavailability of many medications and fewer side effects such as nausea and vomiting.
The purpose of the study is to investigate whether perioperative administration of a rectally administered diazepam suppository results in improved pain scores between 3.5 and 6 hours postoperatively in patients undergoing major vaginal pelvic reconstructive surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
All surgeons, patients and research staff will be blinded.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •English speaking, able to understand informed consent and questionnaires
- •Vaginal hysterectomy with vaginal vault suspension by one of the providers in the Division of Urogynecology and Reconstructive Pelvic Surgery at TriHealth, Inc.
- •With or without anterior and posterior repairs
- •With or without concomitant procedure for stress urinary incontinence
- •With or without removal of fallopian tubes or ovaries
排除标准
- •Use of mesh for prolapse repair
- •Robotic, laparoscopic, or open technique used for prolapse repair and/or hysterectomy
- •Concomitant procedure done by an additional surgeon
- •Concomitant anal sphincteroplasty or rectovaginal fistula repair
- •Contraindication to use of Diazepam:
- •Allergy to Diazepam or other benzodiazepines
- •Acute narrow-angle glaucoma
- •Untreated open-angle glaucoma
- •Myasthenia gravis
- •Severe respiratory impairment
- •Severe hepatic impairment
- •History of chronic pelvic pain receiving medical care
- •Daily use of medication for pain: NSAID, Tylenol, opioid, gabapentin, and/or amitriptyline
- •Pregnancy
研究组 & 干预措施
Diazepam group
Rectal Diazepam suppository
干预措施: Diazepam (Drug)
Placebo group
Placebo suppository
干预措施: Placebos (Drug)
结局指标
主要结局
Vaginal/Rectal pain in Visual Analogue Scale (VAS) score
时间窗: between 3.5 and 6 hours postoperatively
VAS is a validated 100 millimeter scale with no pain as 0 mm and worst pain as 100 mm. Subjects draw a vertical line on the scale corresponding to their pain level.
次要结局
未报告次要终点