Efficacy of IV Acetaminophen Versus Oral Acetaminophen

• Sponsor: University of Rochester (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03365622
• Collaborator: (none)
• Enrollment: 275
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 52.8
• Patients Per Site Per Month: 5.2

Study Details

Study Description

Brief 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 renal cancer at the University of Rochester Medical Center. The standard surgical and post-operative care, including post-operative pain management will not be altered.

Condition or Disease	Intervention/Treatment	Phase
Nephrectomy	Drug: acetaminophen; Drug: Acetaminophen; Drug: Placebos; Drug: Placebo Oral Tablet	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 275 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Randomized, Double-Blind Clinical Study Evaluating Efficacy of Intravenous Versus Enteric Acetaminophen in Donor Nephrectomy and Robot-Assisted, Laparoscopic Nephrectomy.
• Actual Study Start Date: Aug 8, 2018
• Anticipated Primary Completion Date: Dec 31, 2022
• Anticipated Study Completion Date: Dec 31, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Compare pain control for oral and intravenous acetaminophen for post-operative pain control. This will include opiates administered intra-operatively. [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 equivalents).This will include opiates administered intra-operatively.

Secondary Outcome Measures

1. Average surgical pain intensity [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.

2. Mean Inspiratory capacity [1-2 hours post-operatively]

   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

3. Mean total opioid dose used in 24 hours [24 hours]

4. Mean dynamic pain score during incentive spirometer use [20-24 hours post-operatively]

   Pain intensity will be measured using a numeric rating scale of 0 to 10, with 10 being worse pain.

5. Mean dynamic pain score during incentive spirometer use [1-2 hours post-operatively]

   Pain intensity will be measured using a numeric rating scale of 0 to 10, with 10 being worse pain.

6. Mean time to first narcotic use [24 hours]

7. Mean incidence of nausea post-operatively [24 hours]

8. Mean time to discharge from post-anesthesia care unit [24 hours]

9. Mean time to hospital discharge [24 hours]

10. Average surgical pain intensity on a 0-10 numeric rating scale (NRS) [1-2 hours post-operatively]

    Pain intensity will be measured using a numeric rating scale of 0 to 10, with 10 being worse pain.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 89 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Rochester Medical Center	Rochester	New York	United States	14642

Sponsors and Collaborators

• University of Rochester

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Joseph W Dooley, MD, Associate Professor, University of Rochester
• ClinicalTrials.gov Identifier: NCT03365622
• Other Study ID Numbers: 70162
• First Posted: Dec 7, 2017
• Last Update Posted: Jul 7, 2022
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Acetaminophen

Study Results

No Results Posted as of Jul 7, 2022