ClinicalTrials.gg
Active, not recruitingNCT05842044No-PAINUpdated Oct 23, 2026

NSAID Use After Robotic Partial Nephrectomy

A Phase 2 interventional study of Ketorolac and Acetaminophen in Kidney Cancer, Renal Cancer and Renal Neoplasm, sponsored by University of Miami. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-10-23.

Sponsored by University of Miami · Phase 2, Interventional, and Treatment

Updated Oct 23, 2026Now Active, not recruitingPrimary completion moved+1 moreGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
137
Allocation
Randomized
Ages
18 Years to 99 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 551 studies in Kidney Neoplasms with a site in United States — 67 open to participants now, 109 under way, 4 of them phase 3. Kidney Neoplasms · United States.

Enrollment
77th of 443
137 · median 37
Started
2023
with 14 others
Phase 2
206 of 551
13 open now
Primary completion
2026-10
later than 26 of 103 live
Registered
496th of 551
by date

Among the 551 studies in Kidney Neoplasms with a site in United States, this one is the 77th largest by enrollment of the 443 interventional ones, is one of 15 that started in 2023, is one of 206 in phase 2, reaches primary completion later than 26 of the 103 other live ones, and was the 496th registered.

By phase

551 studies; the count open now beside each. This study's row is marked.

Phase 2this study206 · 13 open
Phase 1136 · 14 open
Observational62 · 20 open
No phase58 · 10 open
Phase 1/252 · 7 open
Phase 330 · 1 open
Phase 46 · 2 open
Phase 2/31 · 0 open

By the year they started

First in 1990; this study’s year is marked. 15 started in 2023.

Size and results

Median enrollment 37 across the 443 interventional studies, 350 across the 62 observational. Of the 410 that completed or were terminated, 156 (38%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 551 studies in Kidney Neoplasms with a site in United States, or all of them as a file.
02

Study summary

The purpose of this study is to see how effective non-steroidal anti-inflammatory drugs (NSAIDs) are at controlling pain without side effects in participants after robotic-assisted partial nephrectomy.

03

Conditions studied

  • Kidney Cancer
  • Renal Cancer
  • Renal Neoplasm

Browse trials for

Keywords

  • Non-steroidal anti-inflammatory drugs (NSAIDs)
04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients undergoing uncomplicated robotic assisted laparoscopic partial nephrectomy for renal mass at the University of Miami Hospital and Network Sites (Deerfield Beach, Plantation, Lennar (Coral Gables), and Kendal).
  • Age 18-99.
  • Ability to understand and the willingness to sign a written document.

Exclusion criteria

Exclusion Criteria:

  • Allergy to NSAIDs
  • Myocardial infarction or unstable angina within 12 months.
  • Any history of coronary artery bypass graft surgery.
  • History or active peptic ulcer disease, gastrointestinal (GI) bleeding, GI perforation. History of bleeding disorder. (GFR) \< 60 mL/min/1.73m2 (Modification of Diet in Renal Disease (MDRD) equation).
  • Taking any anti- or anti-coagulation medications concurrently (e.g. warfarin, aspirin, clopidogrel, rivaroxaban etc.)
  • Chronic opioid use (use within 12 weeks) or history of opioid use disorder.
  • Solitary kidney.
  • Pregnancy.
  • Inability to give or unable to meet requirement of the study for any reason.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Care provider, Investigator)
Enrollment
137 participants (actual)

Study arms

  • Experimental
    Group 1: NSAID

    Participants in this group will be prescribed NSAIDs instead of the standard of care treatment. Participants will be in this group for approximately 21 days.

    Drug: Ketorolac · Drug: Acetaminophen · Drug: Oxycodone · Drug: Hydromorphone · Drug: Ibuprofen

  • Active comparator
    Group 2: No-NSAID

    Participants in this group will follow standard of care treatment. Participants will be in this group for approximately 21 days.

    Drug: Acetaminophen · Drug: Oxycodone · Drug: Hydromorphone

Interventions

  • 15-30mg Ketorolac administered via injection during intraoperative period every six (6) hours during post-surgery (inpatient) period.

    Also known as: Ketorolac tromethamine, Toradol, Biorolac

  • 1000mg Acetaminophen administered orally during preoperative period. Standardized regimen of Acetaminophen administered during post-surgery (inpatient) period, during postoperative follow-up period.

    Also known as: Tylenol

  • Standardized regimen of Oxycodone administered orally (PO) on demand for moderate pain during post-surgery (inpatient) period. At discharge 5mg Oxycodone will be administered to participants on demand if pain score is greater than 7, or if participant required greater than 25mg Oxycodone during the hospitalization.

    Also known as: Oxycontin, Roxicodone

  • Standardized regimen of Hydromorphone administered intravenously (IV) on demand for severe pain during post-surgery (inpatient) period.

    Also known as: Dihydromorphinone, Dilaudid, Hydromorph Contin, Palladone

  • 400mg Ibuprofen tablets administered orally (PO) every eight (8) hours for 5 days.

    Also known as: Advil, Motrin

06

What researchers measure

Primary outcomes

  1. Rate of Opioid Use in Postoperative Period

    Rate of opioid use is defined as the number of participants who used opioid medications during the post-operative period (defined as end of surgery to post-operative follow up visit) divided by total number of participants in the group at postoperative visit.

    Time frame: Up to 20 days

Secondary outcomes

  1. Rate of Opioid Medication Use during Hospitalization

    Rate of opioid medication use among study participants during hospitalization, defined as the number of participants who use opioid medication divided by total number of participants in the group during the time between surgery and discharge.

    Time frame: Up to 24 hours

  2. Pain Score Assessed by Standardized Script

    At 24 hours post-surgery and during the postoperative follow-up period, pain score will be elicited from study participants using a standardized script, and scored on scale of 0 to 10, with 0 being no pain and 10 being the worst pain.

    Time frame: Up to 20 days

  3. Pain Score Assessed by International Pain Outcome Questionnaire

    Participants will complete the International Pain Outcome questionnaire during the postoperative and follow-up periods. Scores range from 0 to 10, with higher scores indicating more pain.

    Time frame: Up to 20 days

  4. Number of Treatment-Related Adverse Events

    The number of treatment-related of adverse events among study participants will be assessed by treating physician, post-surgery and after discharge during the postoperative period.

    Time frame: Up to 20 days

  5. Change in Rate of Acute Kidney Injury

    Rate of acute kidney injury at postoperative follow-up visit. Acute kidney injury is defined as a rise of Creatinine greater than (\>) 0.3 from baseline.

    Time frame: Baseline, Up to 20 days

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2023 to primary completion in Oct 2026, 36 months.

Of 64 non-industry phase 2 interventional studies under Kidney Neoplasms, half reached primary completion within 67 months of starting (the median), counting those still running; a quarter within 41 and three quarters within 112. This study's 36 months is below that.

Counting every sponsor, half of 74 studies reached it within 67 months; a quarter within 36 and three quarters within 112.

Primary completion moved once since we started tracking on Sep 25, 2026: Sep 2026 → Oct 2026, on Oct 23, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Apr 24, 2023
First posted
May 3, 2023
StartActual
Sep 15, 2023
Primary completionActual
Oct 9, 2026was Sep 2026
CompletionEst.
Dec 31, 2026
Last update
Oct 23, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Recruiting→Active, not recruiting
changed Oct 23, 2026
Primary completion
Sep 30, 2026→Oct 9, 2026 (actual)
Oct 23, 2026
Enrollment
110 (estimated)→137 (actual)
Oct 23, 2026
Show all 1 update
  1. Oct 23, 2026
    Recruiting→Active, not recruiting
    Primary completion Sep 30, 2026→Oct 9, 2026 (now actual)
    Enrollment 110 (estimated)→137 (actual)
    + 2 other changes: contact details and site details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT05842044
Responsible party
Mark L. Gonzalgo, MD, PhD (Professor of Clinical, University of Miami) — Principal investigator
First posted
May 3, 2023
Start date
Sep 15, 2023
Primary completion
Oct 9, 2026
Completion
Dec 31, 2026 (estimated)
Last update
Oct 23, 2026

Study contacts

Mark L Gonzalgo, MD, PhD
principal investigator · University of Miami

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: Ketorolac · Ibuprofen

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