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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03365622
Other study ID # 70162
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date August 8, 2018
Est. completion date July 31, 2024

Study information

Verified date January 2024
Source University of Rochester
Contact Tammy Ortiz
Phone 585-273-2972
Email tammy_ortiz@urmc.rochester.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 cancer at the University of Rochester Medical Center. The standard surgical and post-operative care, including post-operative pain management will not be altered.


Recruitment information / eligibility

Status Recruiting
Enrollment 265
Est. completion date July 31, 2024
Est. primary completion date July 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 89 Years
Eligibility 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 - Epidural use - History of known liver disease. - Patient unable to take enteral medications. - Be taking opioid medications chronically.

Study Design


Related Conditions & MeSH terms


Intervention

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.
Acetaminophen
500mg acetaminophen tablet ,2 capsules oral every six hours for 24 hours
Placebos
Placebo Intravenous doses will consist of 100ml of normal saline transferred to an empty sterile IV bag.
Placebo Oral Tablet
Placebo, opaque capsules that have been filled with inert powder (lactose USP), 2 capsules oral every six hours for 24 hours

Locations

Country Name City State
United States University of Rochester Medical Center Rochester New York

Sponsors (1)

Lead Sponsor Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Compare pain control for oral and intravenous acetaminophen for post-operative pain control. This will include opiates administered intra-operatively. Total opiate dose used from the study start (when the first dose of acetaminophen is administered in the pre-anesthesia holding area) to 24 hours post-operatively (in morphine milligram equivalents (MME)).This will include opiates administered intra-operatively. 20 to 24 hours post-operatively
Secondary Average surgical pain intensity Average surgical pain intensity on a 0-10 numeric rating scale (NRS) administered between 20 and 24 hours post-operatively, with gatekeeping used to control for multiplicity. 20-24 hours post-operatively
Secondary Mean Inspiratory capacity 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 1-2 hours post-operatively
Secondary Mean total opioid dose (MME) used in 24 hours 24 hours
Secondary Mean dynamic pain score during incentive spirometer use Pain intensity will be measured using a numeric rating scale of 0 to 10, with 10 being worst pain. 20-24 hours post-operatively
Secondary Mean dynamic pain score during incentive spirometer use Pain intensity will be measured using a numeric rating scale of 0 to 10, with 10 being worst pain. 1-2 hours post-operatively
Secondary Mean time to first narcotic use 24 hours
Secondary Mean incidence of nausea post-operatively 24 hours
Secondary Mean time to discharge from post-anesthesia care unit 24 hours
Secondary Mean time to hospital discharge 24 hours
Secondary Average surgical pain intensity on a 0-10 numeric rating scale (NRS) Pain intensity will be measured using a numeric rating scale of 0 to 10, with 10 being worst pain. 1-2 hours post-operatively
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