This phase II trial tests how effective non-steroidal anti-inflammatory drugs (NSAIDs) are at controlling pain without side effects in patients after robotic-assisted partial nephrectomy. To address the continued opioid problem in the United States, multiple institutions have successfully implemented minimal/no-opioid post-operative pain regimens after robotic surgery without worsening pain ratings or increased complications. These protocols rely on a combination of acetaminophen, non-steroidal anti-inflammatories (NSAIDs), and patient counseling. NSAIDs are cyclo-oxygenase (COX) inhibitors and are efficacious in reducing opioid use after surgery. Giving NSAIDs after robotic-assisted partial nephrectomy may work better at controlling pain without side effects.
Additional locations may be listed on ClinicalTrials.gov for NCT05842044.
Locations matching your search criteria
United States
Florida
Miami
University of Miami Miller School of Medicine-Sylvester Cancer CenterStatus: Active
Contact: Mark L. Gonzalgo
Phone: 305-243-3246
PRIMARY OBJECTIVE:
I. To assess the effect of NSAID use after partial nephrectomy on pain control and opioid use during the outpatient post-operative (post-op) period.
SECONDARY OBJECTIVES:
I. To compare rate of opioid use during hospitalization between two groups.
II. To compare pain scores during admission between two groups.
III. To assess pain level at post-operative visit (7-20 days post-op) for each group and compare between two groups.
IV. To assess adverse events (bleeding, cardiac events, poor pain control, etc.) requiring phone call or emergency room (ER) visit for each group.
V. To assess the rate of acute kidney injury (creatinine [Cr] rise > 0.3 above baseline) at post-op visit.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo standard of care (SOC) robotic-assisted partial nephrectomy and receive ketorolac injection at the time of surgery and then every 6 hours during hospital stay. Patients then receive ibuprofen orally (PO) every 8 hours at home for 5 days. Patients also receive standard pain medication as needed around the time of surgery and undergo pain score assessment on study.
ARM II: Patients undergo SOC robotic-assisted partial nephrectomy and receive standard pain medication as needed around the time of surgery. Patients also undergo pain score assessment on study.
After completion of study treatment, patients are followed up 7-20 days post-operatively.
Trial PhasePhase II
Trial Typesupportive care
Lead OrganizationUniversity of Miami Miller School of Medicine-Sylvester Cancer Center
Principal InvestigatorMark L. Gonzalgo
