Efficacy of IV Acetaminophen Versus Oral Acetaminophen

Study Overview
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Brief Summary
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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.

Official Title
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Randomized, Double-Blind Clinical Study Evaluating Efficacy of Intravenous Versus Enteric Acetaminophen in Donor Nephrectomy and Robot-Assisted, Laparoscopic Nephrectomy.

Conditions
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Nephrectomy

Intervention / Treatment
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* Drug: acetaminophen
* Drug: Acetaminophen
* Drug: Placebos
* Drug: Placebo Oral Tablet


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: IV acetaminophen and placebo pills<br> | Drug: acetaminophen<br>* 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.<br>Drug: Placebo Oral Tablet<br>* Placebo, opaque capsules that have been filled with inert powder (lactose USP), 2 capsules oral every six hours for 24 hours<br>|
| Placebo Comparator: placebo IV (normal saline) + oral acetaminophen<br> | Drug: Acetaminophen<br>* 500mg acetaminophen tablet ,2 capsules oral every six hours for 24 hours<br>Drug: Placebos<br>* Placebo Intravenous doses will consist of 100ml of normal saline transferred to an empty sterile IV bag.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Mean total opioid dose (MME) used in 24 hours |  | 24 hours | 
| 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 | 
| 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 | 
| Mean time to first narcotic use |  | 24 hours | 
| Mean incidence of nausea post-operatively |  | 24 hours | 
| Mean time to discharge from post-anesthesia care unit |  | 24 hours | 
| Mean time to hospital discharge |  | 24 hours | 
| 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 |