NephrectomyPhase 4NCT03365622
Efficacy of IV Acetaminophen Versus Oral Acetaminophen
A Phase 4 study testing acetaminophen in people with Nephrectomy, run by University of Rochester at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Nephrectomy
- What is being tested?
- acetaminophen
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 214 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Aug 2018to 10 Apr 2024
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester Medical Center
Rochester, New York, 14642
About this study
Official title: 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.
- Conditions
- Nephrectomy
- Being tested
- acetaminophen, Placebos, Placebo Oral Tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
AcetaminophenDrug
500mg acetaminophen tablet ,2 capsules oral every six hours for 24 hours
PlacebosDrug
Placebo Intravenous doses will consist of 100ml of normal saline transferred to an empty sterile IV bag.
Placebo Oral TabletDrug
Placebo, opaque capsules that have been filled with inert powder (lactose USP), 2 capsules oral every six hours for 24 hours
| Study group | Role | What they receive |
|---|---|---|
| IV acetaminophen and placebo pills | Active comparator | Not described Receives: Drug: acetaminophen; Drug: Placebo Oral Tablet |
| placebo IV (normal saline) + oral acetaminophen | Placebo comparator | Not described Receives: Drug: Acetaminophen; Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 20 to 24 hours post-operatively
Secondary outcomes (11)
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".
Measured: 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".
Measured: 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.
Measured: 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.
Measured: 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".
Measured: 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".
Measured: 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".
Measured: 20-24 hours post-operatively
Time to First Narcotic Use
Time to first postoperative narcotic use, measured in hours (range: 1 to 24).
Measured: 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.
Measured: 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.
Measured: 24 hours
Time to Hospital Discharge
Number of days to discharge from hospital
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2017
- Study start8 Aug 2018
- Primary completion10 Apr 2024
- Study completion10 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for NephrectomyStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph W Dooley, MD, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03365622
- Sponsor's protocol ID
- 70162
- Status last verified
- Jun 2025
- First submitted
- 30 Nov 2017
- Last updated
- 29 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind Clinical Study Evaluating Efficacy of Intravenous Versus Enteric Acetaminophen in Donor Nephrectomy and Robot-Assisted, Laparoscopic Nephrectomy.
- ClinicalTrials.gov ID
- NCT03365622
- Acronym / sponsor ID
- 70162
- Conditions
- Nephrectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- 8 Aug 2018 (actual)
- Primary completion
- 10 Apr 2024 (actual)
- Study completion
- 10 Apr 2024 (actual)
- First posted
- 7 Dec 2017 (actual)
- Results
- Posted 29 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IV acetaminophen and placebo pills | Active comparator | Drug: acetaminophen, Drug: Placebo Oral Tablet |
| placebo IV (normal saline) + oral acetaminophen | Placebo comparator | Drug: Acetaminophen, Drug: Placebos |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acetaminophenActive 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 | IV acetaminophen and placebo pills |
| Acetaminophen500mg acetaminophen tablet ,2 capsules oral every six hours for 24 hours | Drug | placebo IV (normal saline) + oral acetaminophen |
| PlacebosPlacebo Intravenous doses will consist of 100ml of normal saline transferred to an empty sterile IV bag. | Drug | placebo IV (normal saline) + oral acetaminophen |
| Placebo Oral TabletPlacebo, opaque capsules that have been filled with inert powder (lactose USP), 2 capsules oral every six hours for 24 hours | Drug | IV acetaminophen and placebo pills |
Primary outcome
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.
11 secondary outcomes
Average Surgical Pain Intensity
Time frame: 20-24 hours post-operatively
Average Surgical Pain Intensity
Time frame: 1-2 hours post-operatively
Mean Inspiratory Capacity
Time frame: 1-2 hours post-operatively
Mean Inspiratory Capacity
Time frame: 20-24 hours post-operatively
Dynamic Pain Score During Incentive Spirometer Use
Time frame: 1-2 hours post-operatively
Dynamic Pain Score During Incentive Spirometer Use
Time frame: 20-24 hours post-operatively
Surgical Pain Score During the 20-24 Hour Assessment
Time frame: 20-24 hours post-operatively
Time to First Narcotic Use
Time frame: 24 hours post-operatively
Number of Participants With Nausea
Time frame: 24 hours post-operatively
Time to Discharge From Post-anesthesia Care Unit
Time frame: 24 hours
Time to Hospital Discharge
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing acetaminophen in people with Nephrectomy, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Opioid Dose (MME) Used in 24 Hours (time frame: 20 to 24 hours post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2025.