NCT03365622

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
214

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Aug 2018

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 30, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 7, 2017

Completed
8 months until next milestone

Study Start

First participant enrolled

August 8, 2018

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2024

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

June 29, 2025

Completed
Last Updated

June 29, 2025

Status Verified

June 1, 2025

Enrollment Period

5.7 years

First QC Date

November 30, 2017

Results QC Date

April 10, 2025

Last Update Submit

June 11, 2025

Conditions

Nephrectomy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (11)

  • Average Surgical Pain Intensity

    20-24 hours post-operatively

  • Average Surgical Pain Intensity

    1-2 hours post-operatively

  • Mean Inspiratory Capacity

    1-2 hours post-operatively

  • Mean Inspiratory Capacity

    20-24 hours post-operatively

  • Dynamic Pain Score During Incentive Spirometer Use

    1-2 hours post-operatively

  • +6 more secondary outcomes

Study Arms (2)

IV acetaminophen and placebo pills

ACTIVE COMPARATOR
Drug: acetaminophenDrug: Placebo Oral Tablet

placebo IV (normal saline) + oral acetaminophen

PLACEBO COMPARATOR
Drug: AcetaminophenDrug: Placebos

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.

IV acetaminophen and placebo pills
PlacebosDRUG

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

placebo IV (normal saline) + oral acetaminophen
Placebo Oral TabletDRUG

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

IV acetaminophen and placebo pills

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

MeSH Terms

Interventions

Acetaminophen

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Limitations and Caveats

The main limitation was the addition of TAP blocks mid-study for laparoscopic nephrectomy patients. This change likely didn't affect results, as both groups had similar exposure. Variability in gastric drainage, delayed PACU dosing due to lethargy, and prolonged procedures may have influenced outcomes. Lastly, no control group without acetaminophen was included due to ethical concerns over withholding standard pain management.

Results Point of Contact

Title
Joseph Dooley, MD
Organization
University of Rochester Medical Center
joseph_dooley@urmc.rochester.edu
5852752141

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 30, 2017

First Posted

December 7, 2017

Study Start

August 8, 2018

Primary Completion

April 10, 2024

Study Completion

April 10, 2024

Last Updated

June 29, 2025

Results First Posted

June 29, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)