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Recruiting NCT05842044

NSAID Use After Robotic Partial Nephrectomy

Phase II Interventional Kidney Cancer Renal Cancer Renal Neoplasm

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ketorolac, Acetaminophen, Oxycodone, Hydromorphone.
Who it may be relevant to
Registry conditions: Kidney Cancer, Renal Cancer, Renal Neoplasm. Basic parameters: 18 years — 99 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Rate of Opioid Use in Postoperative Period [Time frame: Up to 20 days]
Secondary outcome measures (5)
  • 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

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Miami — Miami

Identifiers

NCT: NCT05842044 · 20220783

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗