NSAID Use After Robotic Partial Nephrectomy

Part of paid clinical trials in Miami, Florida.

Sponsor
University of Miami
Study ID
NCT05842044
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Sep 15, 2023
Status verified
Sep 2025
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
110 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.

Primary Outcome Measure

Rate of Opioid Use in Postoperative Period [ Time Frame: Up to 20 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MiamiMiamiFlorida33136
Mark L Gonzalgo, MD
[email protected]
305-243-3246
Mark L Gonzalgo, MD (PRINCIPAL_INVESTIGATOR)

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