Impact of Placement of a Diazepam Suppository on Early Postoperative Pain Following Pelvic Reconstructive Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Impact of Placement of a Diazepam Suppository Intraoperatively on Early Postoperative Pain Following Pelvic Reconstructive Surgery: a Double-Blind, Randomized Placebo-Controlled Trial

Conditions
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Postoperative Pain

Intervention / Treatment
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* Drug: Diazepam
* Drug: Placebos


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diazepam group<br>Rectal Diazepam suppository | Drug: Diazepam<br>* Diazepam 10 mg compounded suppository<br>|
| Placebo Comparator: Placebo group<br>Placebo suppository | Drug: Placebos<br>* Placebo suppository<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaginal/Rectal pain in Visual Analogue Scale (VAS) score | 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. | between 3.5 and 6 hours postoperatively |