RecruitingInterventionalPhase 2

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

NCT ID: NCT05842044Sponsor: University of MiamiLast updated: 2025-09-05

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.

Arms & interventions

DrugKetorolac
15-30mg Ketorolac administered via injection during intraoperative period every six (6) hours during post-surgery (inpatient) period.
DrugAcetaminophen
1000mg Acetaminophen administered orally during preoperative period. Standardized regimen of Acetaminophen administered during post-surgery (inpatient) period, during postoperative follow-up period.
DrugOxycodone
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.
DrugHydromorphone
Standardized regimen of Hydromorphone administered intravenously (IV) on demand for severe pain during post-surgery (inpatient) period.
DrugIbuprofen
400mg Ibuprofen tablets administered orally (PO) every eight (8) hours for 5 days.

Outcome measures

Primary

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

Rate of Opioid Medication Use during Hospitalization
Time frame: Up to 24 hours
Pain Score Assessed by Standardized Script
Time frame: Up to 20 days
Pain Score Assessed by International Pain Outcome Questionnaire
Time frame: Up to 20 days
Number of Treatment-Related Adverse Events
Time frame: Up to 20 days
Change in Rate of Acute Kidney Injury
Time frame: Baseline, Up to 20 days

Eligibility criteria

Sex: AllAge: 18 Years to 99 YearsHealthy volunteers: No

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 locations (1)

University of Miami

Miami, Florida, 33136

Recruiting

Mark L Gonzalgo, MD · Contact

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

Mark L Gonzalgo, MD · Principal Investigator