NCT05842044

NSAID Use After Robotic Partial Nephrectomy

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: University of Miami · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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

Interventions

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

Timeline

• Start date: 2023-09-15
• Primary completion: 2026-09-30
• Completion: 2026-09-30
• First posted: 2023-05-03
• Last updated: 2025-09-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study