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NCT02156154 · ClinicalTrials.gov registry record · Phase 3
Effect of Intravenous Acetaminophen on Postoperative Opioid-related Complications
A Phase 3 study, sponsored by The Cleveland Clinic.
- Completed
- Registry status
- Phase 3
- Development phase
- 580
- Enrollment target
NCT02156154: Completed Phase 3 study, sponsored by The Cleveland Clinic.
NCT02156154 is a Phase 3 study that has completed, run by The Cleveland Clinic. The registered enrollment target is 580 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (25% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02156154, a Phase 3 study, has completed, sponsored by The Cleveland Clinic.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 580 participants
- Enrollment target
Study Summary
Some patients have respiratory depression (decreased breaths per minute) after surgery. Acetaminophen, an FDA approved pain medication, may prevent this problem. The purpose of this study is to determine if acetaminophen decreases respiratory depression after surgery. The investigators will also evaluate the cost effectiveness of acetaminophen. Patients having elective major abdominal surgery are being asked to participate in this research study. If eligible, a patient will have their baseline tidal volume (amount of air moved into or out of the lungs) and vital capacity (how much air the lungs are capable of holding) measured using a spirometer (apparatus for measuring the volume of air inspired and expired by the lungs) measured before surgery. Three questionnaires will also need to be completed before surgery. The patient will then be randomized, like flipping a coin, to receive either Acetaminophen or placebo (inactive substance) as an infusion throughout surgery and for the first two days thereafter. Neither the patient nor his or her physician will know if the patient is assigned to study drug or placebo. Regardless of study assignment, both groups will receive standard pain management medications and sedation. After surgery, the patient's blood pressure, activity, posture, respiratory rate, the electrical activity of the heart, oxygen saturation, tidal volume, minute ventilation and respiratory rate will be continuously monitored and recorded for 48 hours using a wireless pulse-oximeter and a respiratory volume monitor. 48 hours after surgery the patient will be asked to complete a patient satisfaction questionnaire, which will allow the patient to rate the satisfaction with the treatment received for pain. The patient will also be asked to complete a questionnaire about recovery. At discharge, the patient will be given two questionnaires about pain and quality of life.
Primary Outcome
Hypoxemia is measured as minutes with hypoxemia (Spo2 \<90%) per hour of successful Spo2 monitoring. Patients will have nearly continuous pulseoximeter monitoring and recording. Data from the monitor will be downloaded daily for 48 hours postoperatively.
Interventions
- DRUG Intravenous Acetaminophen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 580 participants |
| Start Date | 2014-12 |
| Est. Completion | 2020-10 |
| Phase | Phase 3 |
What the finished NCT02156154 record still lists
NCT02156154 is an interventional study that assigns participants to a tested intervention. The registered 580 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (25% lower).
The record links to 0 conditions, and to 1 intervention - of which Intravenous Acetaminophen is the first listed.
NCT02156154 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02156154 about?
NCT02156154 is a clinical study titled "Effect of Intravenous Acetaminophen on Postoperative Opioid-related Complications". Some patients have respiratory depression (decreased breaths per minute) after surgery. Acetaminophen, an FDA approved pain medication, may prevent this problem. The purpose of this study is to determine if acetaminophen decreases respiratory depression after surgery. The investigators will also eva...
What is the current status of trial NCT02156154?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 580 participants. The study started on 2014-12. Estimated completion is 2020-10.
What interventions are being tested in trial NCT02156154?
The interventions under investigation include: Intravenous Acetaminophen (DRUG).
Who is sponsoring clinical trial NCT02156154?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02156154's enrollment target sits among peer trials
580 656th of 2000 higher than 1,342 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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