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NCT02043704 · ClinicalTrials.gov registry record · Phase 4
RCT (Randomized Controlled Trial) of IV Acetaminophen for Post Operative Vaginal Reconstruction Pain
A Phase 4 study, sponsored by TriHealth.
- Completed
- Registry status
- Phase 4
- Development phase
- 100
- Enrollment target
NCT02043704: Completed Phase 4 study, sponsored by TriHealth.
NCT02043704 is a Phase 4 study that has completed, run by TriHealth. The registered enrollment target is 100 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02043704, a Phase 4 study, has completed, sponsored by TriHealth.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 100 participants
- Enrollment target
Study 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.
Primary Outcome
Post operative pain will be assessed 18 hours after surgery. Pain will be self reported by patients using a 0-100 mm visual analog scale (VAS) with 0 indicating no pain and 100 indicating the worst pain imaginable. A pain score will be collected for pain while active.
Interventions
- DRUG IV Acetaminophen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2014-01 |
| Est. Completion | 2016-08 |
| Phase | Phase 4 |
What the finished NCT02043704 record still lists
NCT02043704 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 1 intervention - of which IV Acetaminophen is the first listed.
NCT02043704 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02043704 about?
NCT02043704 is a clinical study titled "RCT (Randomized Controlled Trial) of IV Acetaminophen for Post Operative Vaginal Reconstruction Pain". 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...
What is the current status of trial NCT02043704?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 100 participants. The study started on 2014-01. Estimated completion is 2016-08.
What interventions are being tested in trial NCT02043704?
The interventions under investigation include: IV Acetaminophen (DRUG).
Who is sponsoring clinical trial NCT02043704?
This trial is sponsored by TriHealth, which has 81 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02043704's enrollment target sits among peer trials
100 770th of 2000 higher than 1,148 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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