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Efficacy of IV Acetaminophen Versus Oral Acetaminophen

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03365622
Recruitment Status : Recruiting
First Posted : December 7, 2017
Last Update Posted : October 3, 2019
Sponsor:
Information provided by (Responsible Party):
Joseph W Dooley, MD, University of Rochester

Brief Summary:
The aim of this study is to determine whether intravenous acetaminophen compared to enteric acetaminophen offers increased efficacy in patients who are scheduled for laparoscopic donor nephrectomy and for patients scheduled for robot-assisted, laparoscopic nephrectomy for renal cancer at the University of Rochester Medical Center. The standard surgical and post-operative care, including post-operative pain management will not be altered.

Condition or disease Intervention/treatment Phase
Nephrectomy Drug: acetaminophen Drug: Acetaminophen Drug: Placebos Drug: Placebo Oral Tablet Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Double-Blind Clinical Study Evaluating Efficacy of Intravenous Versus Enteric Acetaminophen in Donor Nephrectomy and Robot-Assisted, Laparoscopic Nephrectomy.
Actual Study Start Date : August 8, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: IV acetaminophen and placebo pills Drug: acetaminophen
Active Intravenous doses will consist of a single 1,000mg/100 ml IV dose with contents of commercial vials transferred to an empty sterile IV bag.

Drug: Placebo Oral Tablet
Placebo, opaque capsules that have been filled with inert powder (lactose USP), 2 capsules oral every six hours for 24 hours

Placebo Comparator: placebo IV (normal saline) + oral acetaminophen Drug: Acetaminophen
500mg acetaminophen tablet ,2 capsules oral every six hours for 24 hours

Drug: Placebos
Placebo Intravenous doses will consist of 100ml of normal saline transferred to an empty sterile IV bag.




Primary Outcome Measures :
  1. Average surgical pain intensity on a 0-10 numeric rating scale (NRS) administered . [ Time Frame: 20 to 24 hours post-operatively ]
    Pain intensity will be measured using a numeric rating scale of 0 to 10, with 10 being worse pain.


Secondary Outcome Measures :
  1. Mean Inspiratory capacity [ Time Frame: 20-24 hours post-operatively ]
    The inspiratory capacity will be presented as a percentage of the subject's baseline (pre-operative) inspiratory capacity.Inspiratory capacity is measured using a Voldyne 5000 incentive spirometer (Hudson RCI, Teleflex Medical). Inspiratory capacity will be recorded pre-operatively and at the time of pain assessments (1-2 hours and 20-24 hours post-operatively). Inspiratory capacity will recorded in milliliters to the nearest 250 cc mark on the incentive spirometer. Proper use of the incentive spirometer will be demonstrated to the patient in the pre-anesthesia holding area by a study investigator

  2. Mean Inspiratory capacity [ Time Frame: 1-2 hours post-operatively ]
    The inspiratory capacity will be presented as a percentage of the subject's baseline (pre-operative) inspiratory capacity.Inspiratory capacity is measured using a Voldyne 5000 incentive spirometer (Hudson RCI, Teleflex Medical). Inspiratory capacity will be recorded pre-operatively and at the time of pain assessments (1-2 hours and 20-24 hours post-operatively). Inspiratory capacity will recorded in milliliters to the nearest 250 cc mark on the incentive spirometer. Proper use of the incentive spirometer will be demonstrated to the patient in the pre-anesthesia holding area by a study investigator

  3. Mean total opioid dose used in 24 hours [ Time Frame: 24 hours ]
  4. Mean dynamic pain score during incentive spirometer use [ Time Frame: 20-24 hours post-operatively ]
    Pain intensity will be measured using a numeric rating scale of 0 to 10, with 10 being worse pain.

  5. Mean dynamic pain score during incentive spirometer use [ Time Frame: 1-2 hours post-operatively ]
    Pain intensity will be measured using a numeric rating scale of 0 to 10, with 10 being worse pain.

  6. Mean time to first narcotic use [ Time Frame: 24 hours ]
  7. Mean incidence of nausea post-operatively [ Time Frame: 24 hours ]
  8. Mean time to discharge from post-anesthesia care unit [ Time Frame: 24 hours ]
  9. Mean time to hospital discharge [ Time Frame: 24 hours ]
  10. Average surgical pain intensity on a 0-10 numeric rating scale (NRS) [ Time Frame: 1-2 hours post-operatively ]
    Pain intensity will be measured using a numeric rating scale of 0 to 10, with 10 being worse pain.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Be at least 18 years old
  • Be scheduled for donor nephrectomy or robot-assisted, laparoscopic nephrectomy for cancer at University of Rochester Medical Center
  • Have cognitive ability to verbally rate their pain on the Numeric Rating Scale (NRS).

Exclusion Criteria:

  • Age younger than 18 years old or older than 90 years old
  • Pregnancy (Pre-operative pregnancy test is standard of care for all elective operating room cases)
  • Weight less than 50 kg
  • Anticipated surgical case duration greater than 5 hours
  • Epidural use
  • History of known liver disease.
  • Patient unable to take enteral medications.
  • Be taking opioid medications chronically.

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): NCT03365622


Contacts
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Contact: Nancy Robertson, RN 585-275-1650 nancy_robertson@urmc.rochester.edu
Contact: Tammy Ortiz 585-273-2972 tammy_ortiz@urmc.rochester.edu

Locations
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United States, New York
University of Rochester Medical Center Recruiting
Rochester, New York, United States, 14642
Contact: Nancy Robertson, RN    585-275-1650    nancy_robertson@urmc.rochester.edu   
Contact: Tammy Ortiz    585-273-2972    tammy_ortiz@urmc.rochester.edu   
Sponsors and Collaborators
University of Rochester

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Responsible Party: Joseph W Dooley, MD, Associate Professor, University of Rochester
ClinicalTrials.gov Identifier: NCT03365622    
Other Study ID Numbers: 70162
First Posted: December 7, 2017    Key Record Dates
Last Update Posted: October 3, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics