Impact of Placement of a Diazepam Suppository on Early Postoperative Pain Following Pelvic Reconstructive Surgery
Status unconfirmed · Phase 4 · Has a placebo group
Conditions studied: Postoperative Pain
In brief
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.
Key facts
- Study ID
- NCT04198233
- Run by
- TriHealth Inc.
- People needed
- 130
- Starts
- 2020-02-12
- Expected to finish
- 2022-12-01
- Last updated by the study team
- 2020-07-23
Who can join
Age: 18 and older, up to 80. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Trihealth (Good Samaritan Hospital, Bethesda North Hospital) — Cincinnati, Ohio, United States (enrolling)
Full record on ClinicalTrials.gov
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