RCT (Randomized Controlled Trial) of IV Acetaminophen for Post Operative Vaginal Reconstruction Pain
| Status: | Completed |
|---|---|
| Conditions: | Post-Surgical Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 8/18/2018 |
| Start Date: | January 2014 |
| End Date: | August 2016 |
The Effect of Intravenous Acetaminophen on Post-operative Pain and Narcotic Consumption in Vaginal Reconstructive Surgery Patients: A Randomized Controlled Trial
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.
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.
see brief summary
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
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