RCT (Randomized Controlled Trial) of IV Acetaminophen for Post Operative Vaginal Reconstruction Pain
Completed · Phase 4
Conditions studied: Post Operative Pain
In brief
This randomized controlled trial will evaluate the effects of perioperative intravenous (IV) acetaminophen on postoperative narcotic consumption and pain scores in subjects undergoing vaginal reconstructive surgery. One hundred subjects will be randomly assigned to receive either IV acetaminophen or IV placebo. Those in the IV acetaminophen group will receive 1000mg IV every 6 hours for 24 hours beginning prior to anesthesia induction. The control group will receive placebo saline infusions at the same time intervals. All subjects will receive as needed (prn) IV narcotic for additional pain relief. Visual analog scales (VAS) regarding pain will be evaluated at 18 and 24 hours postoperative and immediately prior to discharge. We will also collect total IV narcotic consumption. We hypothesize that subjects receiving IV acetaminophen will have lower VAS scores and decreased total narcotic consumption in comparison to the control group.
Key facts
- Study ID
- NCT02043704
- Run by
- TriHealth Inc.
- People needed
- 100
- Starts
- 2014-01-01
- Expected to finish
- 2016-08-01
- Last updated by the study team
- 2018-08-16
Who can join
Age: 18 and older, up to 70. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Women between the ages of 18 and 70 years
- Patients of the Division of Urogynecology at Good Samaritan and Bethesda North Hospitals in Cincinnati, Ohio
- Scheduled to undergo major vaginal reconstruction
- Must undergo total vaginal hysterectomy, anterior repair, posterior repair, enterocele repair, and intraperitoneal vault suspension. The addition of suburethral sling is not a cause for exclusion.
You may not qualify if…
- Allergy to acetaminophen
- Liver disease (chronic or active)
- Chronic alcohol use (>1 drink/day)
- Bleeding diathesis
- Renal disease
- Opiate dependent or daily use
- History of chronic pain
- Mental or cognitive disorder preventing patient to accurately verbalize pain levels
- Undergoing abdominal or laparoscopic procedures at the time of surgery
- Allergy to hydromorphone
- Surgery is not performed under general anesthesia
Where it is running
- TriHealth - Good Samaritan and Bethesda North Hospitals — Cincinnati, Ohio, United States
Full record on ClinicalTrials.gov
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