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
- 214
- 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 Total Opioid Dose (MME) Used in 24 Hours 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 Average Surgical Pain Intensity 1-2 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. A larger NRS score means the patient is experiencing more pain, with 0 representing "no pain" and 10 representing "the worst possible pain".
Mean Inspiratory Capacity 20-24 hours post-operatively The mean inspiratory capacity is presented as a percentage of the subject's baseline (pre-operative) inspiratory capacity, recorded at the time of pain intensity assessments between 20-24 hours postoperatively. Inspiratory capacity is measured using a Voldyne 5000 incentive spirometer (Hudson RCI, Teleflex Medical) and recorded in milliliters to the nearest 250 cc mark on the incentive spirometer. Higher percentages reflect better recovery of inspiratory function.
Dynamic Pain Score During Incentive Spirometer Use 20-24 hours post-operatively Dynamic pain score on a 0-10 numeric rating scale (NRS) with incentive spirometer use taken during pain intensity assessments at 20-24 hours post-operatively. A larger NRS score means the patient is experiencing more pain, with 0 representing "no pain" and 10 representing "the worst possible pain".
Surgical Pain Score During the 20-24 Hour Assessment 20-24 hours post-operatively Pain intensity on a 0-10 numeric rating scale (NRS) prior to incentive spirometry use was taken during pain intensity assessments at 20-24 hours post-operatively. A larger NRS score means the patient is experiencing more pain, with 0 representing "no pain" and 10 representing "the worst possible pain".
Time to First Narcotic Use 24 hours post-operatively Time to first postoperative narcotic use, measured in hours (range: 1 to 24).
Number of Participants With Nausea 24 hours post-operatively Number of participants with nausea was assessed based on the administration of anti-emetic medications, with a value of 0 indicating no nausea and 1 indicating the presence of nausea.
Time to Discharge From Post-anesthesia Care Unit 24 hours Length of time in minutes from PACU(post-anesthesia care unit) arrival to discharge.
Time to Hospital Discharge 30 days Number of days to discharge from hospital
Trial Locations
- Locations (1)
University of Rochester Medical Center
🇺🇸Rochester, New York, United States
University of Rochester Medical Center🇺🇸Rochester, New York, United States