Efficacy of IV Acetaminophen Versus Oral Acetaminophen

University of Rochester214 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

214

Conditions

Nephrectomy

Interventions

acetaminophenDRUG

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.

AcetaminophenDRUG

500mg acetaminophen tablet ,2 capsules oral every six hours for 24 hours

PlacebosDRUG

Placebo Intravenous doses will consist of 100ml of normal saline transferred to an empty sterile IV bag.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 89 Years

Medical Language ↔ Plain English

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.

Locations (1)

University of Rochester Medical Center

Rochester, New York, United States

Outcomes

Primary Outcomes

Total Opioid Dose (MME) Used in 24 Hours

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.

Time frame: 20 to 24 hours post-operatively

Secondary Outcomes

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. A larger NRS score means the patient is experiencing more pain, with 0 representing "no pain" and 10 representing "the worst possible pain".

Time frame: 20-24 hours post-operatively

Average Surgical Pain Intensity

Time frame: 1-2 hours post-operatively

Mean Inspiratory Capacity

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 1-2 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.

Time frame: 1-2 hours post-operatively

Mean Inspiratory Capacity

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.

Data from ClinicalTrials.gov

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