Randomized, Double-Blind Clinical Study Evaluating Efficacy of Intravenous Versus Enteric Acetaminophen in Donor Nephrectomy and Robot-Assisted, Laparoscopic Nephrectomy.
Overview
- Phase
- Phase 4
- Intervention
- Acetaminophen
- Conditions
- Nephrectomy
- Sponsor
- University of Rochester
- Enrollment
- 214
- Locations
- 1
- Primary Endpoint
- Total Opioid Dose (MME) Used in 24 Hours
- Status
- Completed
- Last Updated
- 10 months ago
Overview
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 cancer at the University of Rochester Medical Center. The standard surgical and post-operative care, including post-operative pain management will not be altered.
Investigators
Joseph W Dooley, MD
Associate Professor
University of Rochester
Eligibility 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
- •Epidural use
- •History of known liver disease.
- •Patient unable to take enteral medications.
- •Be taking opioid medications chronically.
Arms & Interventions
placebo IV (normal saline) + oral acetaminophen
Intervention: Acetaminophen
IV acetaminophen and placebo pills
Intervention: Acetaminophen
IV acetaminophen and placebo pills
Intervention: Placebo Oral Tablet
placebo IV (normal saline) + oral acetaminophen
Intervention: Placebos
Outcomes
Primary Outcomes
Total Opioid Dose (MME) Used in 24 Hours
Time Frame: 20 to 24 hours post-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.
Secondary Outcomes
- Average Surgical Pain Intensity(1-2 hours post-operatively)
- Mean Inspiratory Capacity(20-24 hours post-operatively)
- Dynamic Pain Score During Incentive Spirometer Use(20-24 hours post-operatively)
- Surgical Pain Score During the 20-24 Hour Assessment(20-24 hours post-operatively)
- Time to First Narcotic Use(24 hours post-operatively)
- Number of Participants With Nausea(24 hours post-operatively)
- Time to Discharge From Post-anesthesia Care Unit(24 hours)
- Time to Hospital Discharge(30 days)