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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 is a Phase 3 study that has completed, run by The Cleveland Clinic. The registered enrollment target is 580 participants.
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.
Interventions
- DRUG Intravenous Acetaminophen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 580 participants |
| Start Date | 2014-12 |
| Est. Completion | 2020-10 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02156154
The ClinicalTrials.gov registry entry for NCT02156154 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 580 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The Cleveland Clinic, which has 688 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Intravenous Acetaminophen is the first listed.
NCT02156154 reports 0 study locations.
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.
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