Effect of Intravenous Acetaminophen on Postoperative Opioid-related Complications



Status:Active, not recruiting
Conditions:Post-Surgical Pain
Therapuetic Areas:Musculoskeletal
Healthy:No
Age Range:18 - 85
Updated:2/3/2019
Start Date:December 2014
End Date:March 2019

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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.


Inclusion Criteria:

- Written informed consent

- 18-85 years old

- above 50 kg

- ASA Physical Status 1-3

- Scheduled for elective open or laparoscopic abdominal surgery, including colorectal,
prostate, and hysterectomy surgeries

- Patients with anticipated hospitalization of two nights

- Expected to require parenteral opioids for at least 48 hours for postoperative pain

- Able to use IV PCA systems

Exclusion Criteria:

- Hepatic disease, e.g. twice the normal levels of liver enzymes

- Kidney disease, e.g. twice the normal level of serum creatinine

- Epidural analgesia or regional blocks (including TAP block)

- Acetaminophen sensitivity or known allergy

- Female patients who are pregnant or breastfeeding

- Patients taking warfarin
We found this trial at
2
sites
2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Principal Investigator: Alparslan Turan, M.D.
Phone: 216-445-9857
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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Cleveland, OH
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
?
mi
from
Cleveland, OH
Click here to add this to my saved trials