RCT (Randomized Controlled Trial) of IV Acetaminophen for Post Operative Vaginal Reconstruction Pain (NCT02043704) | Clinical Trial Compass
CompletedPhase 4
RCT (Randomized Controlled Trial) of IV Acetaminophen for Post Operative Vaginal Reconstruction Pain
United States100 participantsStarted 2014-01
Plain-language summary
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.
Who can participate
Age range
18 Years – 70 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pain While Active - 18 hr
Timeframe: 18 hours
2
Total Amount of Narcotic Consumption in the First 24 Hours Post Surgery