Clinical trial
NSAID Use After Robotic Partial Nephrectomy (No-PAIN): a Randomized, Controlled Trial
Name
20220783
Description
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.
Trial arms
Trial start
2023-09-15
Estimated PCD
2025-09-30
Trial end
2025-09-30
Status
Recruiting
Phase
Early phase I
Treatment
Ketorolac
15-30mg Ketorolac administered via injection during intraoperative period every six (6) hours during post-surgery (inpatient) period.
Arms:
Group 1: NSAID
Other names:
Ketorolac tromethamine, Toradol, Biorolac
Acetaminophen
1000mg Acetaminophen administered orally during preoperative period. Standardized regimen of Acetaminophen administered during post-surgery (inpatient) period, during postoperative follow-up period.
Arms:
Group 1: NSAID, Group 2: No-NSAID
Other names:
Tylenol
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.
Arms:
Group 1: NSAID, Group 2: No-NSAID
Other names:
Oxycontin, Roxicodone
Hydromorphone
Standardized regimen of Hydromorphone administered intravenously (IV) on demand for severe pain during post-surgery (inpatient) period.
Arms:
Group 1: NSAID, Group 2: No-NSAID
Other names:
Dihydromorphinone, Dilaudid, Hydromorph Contin, Palladone
Ibuprofen
400mg Ibuprofen tablets administered orally (PO) every eight (8) hours for 5 days.
Arms:
Group 1: NSAID
Other names:
Advil, Motrin
Size
110
Primary endpoint
Rate of Opioid Use in Postoperative Period
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'After study recruitment, the patient will be randomized to the NSAID group (group 1) vs. the no-NSAID group (group 2). Randomization will be masked until after the renorrhaphy is completed and the surgical team will administer versus not administer ketorolac based on group assignment.', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 110, 'type': 'ESTIMATED'}}
Updated at
2023-11-07
1 organization
5 products
2 indications
Organization
University of MiamiProduct
KetorolacIndication
Renal Cell CarcinomaIndication
Kidney TumorProduct
AcetaminophenProduct
OxycodoneProduct
HydromorphoneProduct
Ibuprofen