Efficacy of IV Acetaminophen Versus Oral Acetaminophen
- Conditions
- Nephrectomy
- Interventions
- Registration Number
- NCT03365622
- Lead Sponsor
- 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 cancer at the University of Rochester Medical Center. The standard surgical and post-operative care, including post-operative pain management will not be altered.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 265
- 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).
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description placebo IV (normal saline) + oral acetaminophen Placebos - IV acetaminophen and placebo pills Placebo Oral Tablet - IV acetaminophen and placebo pills Acetaminophen - placebo IV (normal saline) + oral acetaminophen Acetaminophen -
- Primary Outcome Measures
Name Time Method Compare pain control for oral and intravenous acetaminophen for post-operative pain control. This will include opiates administered intra-operatively. 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 Outcome Measures
Name Time Method Mean time to hospital discharge 24 hours Average surgical pain intensity on a 0-10 numeric rating scale (NRS) 1-2 hours post-operatively Pain intensity will be measured using a numeric rating scale of 0 to 10, with 10 being worst pain.
Mean incidence of nausea post-operatively 24 hours Mean time to discharge from post-anesthesia care unit 24 hours Average surgical pain intensity 20-24 hours post-operatively 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.
Mean Inspiratory capacity 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
Mean total opioid dose (MME) used in 24 hours 24 hours Mean dynamic pain score during incentive spirometer use 1-2 hours post-operatively Pain intensity will be measured using a numeric rating scale of 0 to 10, with 10 being worst pain.
Mean time to first narcotic use 24 hours
Trial Locations
- Locations (1)
University of Rochester Medical Center
🇺🇸Rochester, New York, United States