NSAID Use After Robotic Partial Nephrectomy (No-PAIN)

NSAID Use After Robotic Partial Nephrectomy (No-PAIN): a Randomized, Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Kidney Cancer; Renal Cancer; Renal Neoplasm
• Intervention / Treatment: Drug: Ketorolac; Drug: Acetaminophen; Drug: Oxycodone; Drug: Hydromorphone; Drug: Ibuprofen

• Study Type: Interventional
• Enrollment (Estimated): 110
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Mark L Gonzalgo, MD, PhD; Phone Number: 305-243-3246; Email: m.gonzalgo@med.miami.edu

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Recruiting
      • University of Miami
      • Contact: Mark L Gonzalgo, MD; Phone Number: 305-243-3246; Email: m.gonzalgo@med.miami.edu
      • Principal Investigator: Mark L Gonzalgo, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 15-30mg Ketorolac administered via injection during intraoperative period every six (6) hours during post-surgery (inpatient) period.; Other Names: Toradol; Biorolac; Ketorolac tromethamine; Drug: Acetaminophen; 1000mg Acetaminophen administered orally during preoperative period. Standardized regimen of Acetaminophen administered during post-surgery (inpatient) period, during postoperative follow-up period.; Other Names: Tylenol; Drug: 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.; Other Names: Oxycontin; Roxicodone; Drug: Hydromorphone; Standardized regimen of Hydromorphone administered intravenously (IV) on demand for severe pain during post-surgery (inpatient) period.; Other Names: Dilaudid; Dihydromorphinone; Hydromorph Contin; Palladone; Drug: Ibuprofen; 400mg Ibuprofen tablets administered orally (PO) every eight (8) hours for 5 days.; Other Names: Advil; Motrin
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; 1000mg Acetaminophen administered orally during preoperative period. Standardized regimen of Acetaminophen administered during post-surgery (inpatient) period, during postoperative follow-up period.; Other Names: Tylenol; Drug: 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.; Other Names: Oxycontin; Roxicodone; Drug: Hydromorphone; Standardized regimen of Hydromorphone administered intravenously (IV) on demand for severe pain during post-surgery (inpatient) period.; Other Names: Dilaudid; Dihydromorphinone; Hydromorph Contin; Palladone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 24 hours
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.	Up to 20 days
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.	Up to 20 days
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.	Up to 20 days
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.	Baseline, Up to 20 days

Collaborators and Investigators

• Sponsor: University of Miami
• Investigators: Principal Investigator: Mark L Gonzalgo, MD, PhD, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2023
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: April 24, 2023
• First Submitted That Met QC Criteria: April 24, 2023
• First Posted (Actual): May 3, 2023

Study Record Updates

• Last Update Posted (Estimated): September 5, 2025
• Last Update Submitted That Met QC Criteria: September 3, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Non-steroidal anti-inflammatory drugs (NSAIDs)
• Additional Relevant MeSH Terms: Urogenital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urologic Neoplasms; Kidney Neoplasms; Organic Chemicals; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Carboxylic Acids; Alkaloids; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Anilides; Amides; Aniline Compounds; Amines; Acetanilides; Indomethacin; Indoles; Heterocyclic Compounds, 4 or More Rings; Acids, Carbocyclic; Morphinans; Opiate Alkaloids; Heterocyclic Compounds, Bridged-Ring; Phenanthrenes; Morphine Derivatives; Codeine; Phenylpropionates; Acetaminophen; Ketorolac; Hydromorphone; Ketorolac Tromethamine; Ibuprofen; Oxycodone
• Other Study ID Numbers: 20220783

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No