Efficacy of IV Acetaminophen Versus Oral Acetaminophen

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

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 Overview

• Status: Completed
• Conditions: Nephrectomy
• Intervention / Treatment: Drug: acetaminophen; Drug: Placebo Oral Tablet; Drug: Acetaminophen; Drug: Placebos

• Study Type: Interventional
• Enrollment (Actual): 214
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14642
      • University of Rochester Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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. A larger NRS score means the patient is experiencing more pain, with 0 representing "no pain" and 10 representing "the worst possible pain".	20-24 hours post-operatively
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".	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.	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.	20-24 hours post-operatively
Dynamic Pain Score During Incentive Spirometer Use	Dynamic pain score on a 0-10 numeric rating scale (NRS) with incentive spirometer use taken during pain intensity assessments at 1-2 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".	1-2 hours post-operatively
Dynamic Pain Score During Incentive Spirometer Use	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".	20-24 hours post-operatively
Surgical Pain Score During the 20-24 Hour Assessment	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".	20-24 hours post-operatively
Time to First Narcotic Use	Time to first postoperative narcotic use, measured in hours (range: 1 to 24).	24 hours post-operatively
Number of Participants With Nausea	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.	24 hours post-operatively
Time to Discharge From Post-anesthesia Care Unit	Length of time in minutes from PACU(post-anesthesia care unit) arrival to discharge.	24 hours
Time to Hospital Discharge	Number of days to discharge from hospital	30 days

Collaborators and Investigators

• Sponsor: University of Rochester

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2018
• Primary Completion (Actual): April 10, 2024
• Study Completion (Actual): April 10, 2024

Study Registration Dates

• First Submitted: November 30, 2017
• First Submitted That Met QC Criteria: December 6, 2017
• First Posted (Actual): December 7, 2017

Study Record Updates

• Last Update Posted (Actual): June 29, 2025
• Last Update Submitted That Met QC Criteria: June 11, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Antipyretics; Acetaminophen
• Other Study ID Numbers: 70162

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No