Recruiting
Phase 2

NSAID

Sponsor:

University of Miami

Code:

NCT05842044

Conditions

Kidney Cancer

Renal Cancer

Renal Neoplasm

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Ketorolac

Acetaminophen

Oxycodone

Hydromorphone

Ibuprofen

Study Details

Brief 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.

Conditions

Kidney Cancer

Renal Cancer

Renal Neoplasm

Study ID

NCT05842044

Start date

Sep 15, 2023

Status verified date

Sep, 2025

Completion date

Sep 30, 2026

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 informed consent document.

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. Glomerular filtration rate (GFR) < 60 mL/min/1.73m2 (Modification of Diet in Renal Disease (MDRD) equation).
  • Taking any anti-platelet 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 informed consent or unable to meet requirement of the study for any reason.

Study Design

Enrollment

110 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

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.

Interventions

Ketorolac

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

Acetaminophen

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

Oxycodone

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.

Hydromorphone

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

Ibuprofen

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

Primary outcome measure

  • Rate of Opioid Use in Postoperative Period [ Time Frame: Up to 20 days ]

Central Contacts and Locations

Central contacts

Mark L Gonzalgo, MD, PhD

305-243-3246m.gonzalgo@med.miami.edu

Locations

University of Miami

Recruiting

Miami, Florida, United States, 33136

Contacts

Mark L Gonzalgo, MD

305-243-3246m.gonzalgo@med.miami.edu

Principal Investigator:

Mark L Gonzalgo, MD

More Information

Sponsor

University of Miami

Last update posted

Sep 5, 2025

Last verified

Sep, 2025

Keywords

  • Non-steroidal anti-inflammatory drugs (NSAIDs)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Miami on 2025-09-05.