Status and phase
Conditions
Treatments
About
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.
Full description
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.
Enrollment
Sex
Ages
Volunteers
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.
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:
History of chronic pelvic pain receiving medical care
Daily use of medication for pain: NSAID, Tylenol, opioid, gabapentin, and/or amitriptyline
Pregnancy
Primary purpose
Allocation
Interventional model
Masking
130 participants in 2 patient groups, including a placebo group
Loading...
Central trial contact
Eunsun Yook, MS; Emily Aldrich, MD
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal