Effect of Intravenous Acetaminophen on Postoperative Opioid-related Complications
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|ClinicalTrials.gov Identifier: NCT02156154|
Recruitment Status : Active, not recruiting
First Posted : June 5, 2014
Last Update Posted : April 17, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Postoperative Pain||Drug: Intravenous Acetaminophen||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||528 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Effect of Intravenous Acetaminophen on Postoperative Opioid-related Complications|
|Study Start Date :||December 2014|
|Actual Primary Completion Date :||March 2019|
|Estimated Study Completion Date :||June 2020|
Placebo Comparator: Intravenous 0.9% sodium chloride
0.9% sodium chloride infusion will be initiated before the surgical incision with 100 ml and repeated every 6 hours for the earlier of 48 postoperative hours of hospital discharge.
Drug: Intravenous Acetaminophen
Experimental: Intravenous Acetaminophen
Acetaminophen infusion will be initiated before the surgical incision with 1 g and repeated every 6 hours for the earlier of 48 postoperative hours of hospital discharge.
Drug: Intravenous Acetaminophen
- Pulseoxymeter [ Time Frame: 2 days ]Patients will have nearly continuous pulseoxymeter monitoring and recording. Data from the monitor will be downloaded daily for 48 hours postoperatively, incidence of hypoxia and the time spent hypoxic will be determined.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02156154
|United States, Ohio|
|Cleveland Clinic Foundation|
|Cleveland, Ohio, United States, 44195|
|Principal Investigator:||Alparslan Turan, M.D.||The Cleveland Clinic|