A Phase 4 interventional study of Diazepam and Placebos in Postoperative Pain, sponsored by TriHealth Inc.. Status unknown at 1 site in United States. Open to female participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-07-23.
Sponsored by TriHealth Inc. · Phase 4, Interventional, and Supportive care
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.
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.
5,089 studies on the registry are indexed under Pain, Postoperative; 1,137 are open to participants now.
This study's planned enrollment of 130 is above the median of 75 across 4,341 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →TriHealth Inc. is the lead sponsor of 99 studies on the registry; 9 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 4 (44%) have results posted.
Counted across the registry records on this site, refreshed daily.
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:
Contraindication to use of Diazepam:
Rectal Diazepam suppository
Drug: Diazepam
Placebo suppository
Drug: Placebos
Diazepam 10 mg compounded suppository
Placebo suppository
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.
Time frame: between 3.5 and 6 hours postoperatively
This study is status unknown, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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TriHealth Inc.