NSAID Use After Robotic Partial Nephrectomy

Phase 2

Recruiting

• Conditions: Renal Neoplasm; Renal Cancer; Kidney Cancer
• Interventions: Drug: Ketorolac; Drug: Acetaminophen; Drug: Oxycodone; Drug: Hydromorphone; Drug: Ibuprofen

• Registration Number: NCT05842044
• Lead Sponsor: University of Miami

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-24
• Study First Submitted QC: 2023-04-24
• Study First Posted: 2023-05-03
• Study Start: 2023-09-15
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-04
• Last Update Posted: 2024-10-08
• Primary Completion: 2025-09-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 110

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1: NSAID	Ketorolac	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.
Group 1: NSAID	Acetaminophen	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.
Group 1: NSAID	Oxycodone	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.
Group 1: NSAID	Hydromorphone	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.
Group 2: No-NSAID	Acetaminophen	Participants in this group will follow standard of care treatment. Participants will be in this group for approximately 21 days.
Group 1: NSAID	Ibuprofen	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.
Group 2: No-NSAID	Oxycodone	Participants in this group will follow standard of care treatment. Participants will be in this group for approximately 21 days.
Group 2: No-NSAID	Hydromorphone	Participants in this group will follow standard of care treatment. Participants will be in this group for approximately 21 days.

Primary Outcome Measures

Name	Time	Method
Rate of Opioid Use in Postoperative Period	Up to 20 days	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States