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Trial record 1 of 1 for:    NCT02156154
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Effect of Intravenous Acetaminophen on Postoperative Opioid-related Complications

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ClinicalTrials.gov Identifier: NCT02156154
Recruitment Status : Recruiting
First Posted : June 5, 2014
Last Update Posted : January 17, 2018
Sponsor:
Information provided by (Responsible Party):
Alparslan Turan, The Cleveland Clinic

Brief 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.


Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: Intravenous Acetaminophen Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 528 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Intravenous Acetaminophen on Postoperative Opioid-related Complications
Study Start Date : December 2014
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

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


Contacts
Contact: Alparslan Turan, M.D. 1-216-445-9857 turana@ccf.org

Locations
United States, Ohio
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Alparslan Turan, M.D.    216-445-9857    turana@ccf.org   
Contact: Roberta Johnson, BA    216-444-9950    johnsor13@ccf.org   
Principal Investigator: Alparslan Turan, M.D.         
Cleveland Clinic Foundation Not yet recruiting
Cleveland, Ohio, United States, 44195
Contact: Alparslan Turan, M.D.    216-445-9857    turana@ccf.org   
Contact: Roberta Johnson, BA    216-444-9950    johnsor13@ccf.org   
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: Alparslan Turan, M.D. The Cleveland Clinic

Responsible Party: Alparslan Turan, Associate Staff Anesthesiologist, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT02156154     History of Changes
Other Study ID Numbers: 14-241
First Posted: June 5, 2014    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics