Efficacy of IV Acetaminophen Versus Oral Acetaminophen

Nephrectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03365622
• Other study ID #: 70162
• Status: Recruiting
• Phase: Phase 4
• Start date: August 8, 2018
• Est. completion date: July 31, 2024

Study information

• Verified date: January 2024
• Source: University of Rochester
• Contact: Tammy Ortiz
• Phone: 585-273-2972
• Email: tammy_ortiz[@]urmc.rochester.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 265
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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.

Related Conditions & MeSH terms

• Nephrectomy

Intervention

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.
• Acetaminophen
500mg acetaminophen tablet ,2 capsules oral every six hours for 24 hours
• Placebos
Placebo Intravenous doses will consist of 100ml of normal saline transferred to an empty sterile IV bag.
• Placebo Oral Tablet
Placebo, opaque capsules that have been filled with inert powder (lactose USP), 2 capsules oral every six hours for 24 hours

Locations

Country	Name	City	State
United States	University of Rochester Medical Center	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Mean total opioid dose (MME) used in 24 hours		24 hours
Secondary	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
Secondary	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
Secondary	Mean time to first narcotic use		24 hours
Secondary	Mean incidence of nausea post-operatively		24 hours
Secondary	Mean time to discharge from post-anesthesia care unit		24 hours
Secondary	Mean time to hospital discharge		24 hours
Secondary	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