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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-12

Study Completion Date

2022-12-31

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.

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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.

Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

All surgeons, patients and research staff will be blinded.

Study Groups

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Diazepam group

Rectal Diazepam suppository

Group Type EXPERIMENTAL

Diazepam

Intervention Type DRUG

Diazepam 10 mg compounded suppository

Placebo group

Placebo suppository

Group Type PLACEBO_COMPARATOR

Placebos

Intervention Type DRUG

Placebo suppository

Interventions

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Diazepam

Diazepam 10 mg compounded suppository

Intervention Type DRUG

Placebos

Placebo suppository

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No