NSAID Use After Robotic Partial Nephrectomy

NCT05842044 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 20220783
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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

Keywords

Non-steroidal anti-inflammatory drugs (NSAIDs)

Outcome Measures

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.

  Up to 20 days

Secondary Outcomes (5)

• Rate of Opioid Medication Use during Hospitalization

  Up to 24 hours

• Pain Score Assessed by Standardized Script

  Up to 20 days

• Pain Score Assessed by International Pain Outcome Questionnaire

  Up to 20 days

• Number of Treatment-Related Adverse Events

  Up to 20 days

• Change in Rate of Acute Kidney Injury

  Baseline, Up to 20 days

Study Arms (2)

Group 1: NSAID

EXPERIMENTAL

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

Group 2: No-NSAID

ACTIVE COMPARATOR

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

Ketorolac DRUG

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

Group 1: NSAID

Acetaminophen DRUG

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

Group 1: NSAID; Group 2: No-NSAID

Oxycodone DRUG

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

Group 1: NSAID; Group 2: No-NSAID

Hydromorphone DRUG

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

Group 1: NSAID; Group 2: No-NSAID

Ibuprofen DRUG

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

Also known as: Advil, Motrin

Group 1: NSAID

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

RECRUITING

MeSH Terms

Conditions

Kidney Neoplasms

Interventions

Ketorolac; Ketorolac Tromethamine; Acetaminophen; Oxycodone; Hydromorphone; Ibuprofen

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids

Study Officials

• Mark L Gonzalgo, MD, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mark L Gonzalgo, MD, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Masking Details: After study recruitment, the patient will be randomized to the NSAID group (group 1) vs. the no-NSAID group (group 2). Randomization will be masked until after the renorrhaphy is completed and the surgical team will administer versus not administer ketorolac based on group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical

Study Record Dates

• First Submitted: April 24, 2023
• First Posted: May 3, 2023
• Study Start: September 15, 2023
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: September 5, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)