Skip to main content
OpenTrials
Completed

NCT Number: NCT03365622

Efficacy of IV Acetaminophen Versus Oral Acetaminophen

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Nephrectomy

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Acetaminophen

Drug

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.

Placebos

Drug

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

Placebo oral tablet

Drug

Placebo, opaque capsules that have been filled with inert powder (lactose USP), 2 capsules oral every six hours for 24 hours

Primary outcomes

  1. Total Opioid Dose (MME) Used in 24 Hours

    Time frame: 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 outcomes

  1. Average Surgical Pain Intensity

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

  2. Average Surgical Pain Intensity

    Time frame: 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".

  3. Mean Inspiratory Capacity

    Time frame: 1-2 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 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.

  4. Mean Inspiratory Capacity

    Time frame: 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.

  5. Dynamic Pain Score During Incentive Spirometer Use

    Time frame: 1-2 hours post-operatively

    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".

  6. Dynamic Pain Score During Incentive Spirometer Use

    Time frame: 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".

  7. Surgical Pain Score During the 20-24 Hour Assessment

    Time frame: 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".

  8. Time to First Narcotic Use

    Time frame: 24 hours post-operatively

    Time to first postoperative narcotic use, measured in hours (range: 1 to 24).

  9. Number of Participants With Nausea

    Time frame: 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.

  10. Time to Discharge From Post-anesthesia Care Unit

    Time frame: 24 hours

    Length of time in minutes from PACU(post-anesthesia care unit) arrival to discharge.

  11. Time to Hospital Discharge

    Time frame: 30 days

    Number of days to discharge from hospital

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Dec 7, 2017
Registry last updated
Jun 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.