To hear about similar clinical trials, please enter your email below
Trial Title:
NSAID Use After Robotic Partial Nephrectomy
NCT ID:
NCT05842044
Condition:
Kidney Cancer
Renal Cancer
Renal Neoplasm
Conditions: Official terms:
Kidney Neoplasms
Acetaminophen
Ibuprofen
Ketorolac
Ketorolac Tromethamine
Oxycodone
Hydromorphone
Conditions: Keywords:
Non-steroidal anti-inflammatory drugs (NSAIDs)
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Double (Care Provider, Investigator)
Masking description:
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.
Intervention:
Intervention type:
Drug
Intervention name:
Ketorolac
Description:
15-30mg Ketorolac administered via injection during intraoperative period every six (6)
hours during post-surgery (inpatient) period.
Arm group label:
Group 1: NSAID
Other name:
Ketorolac tromethamine
Other name:
Toradol
Other name:
Biorolac
Intervention type:
Drug
Intervention name:
Acetaminophen
Description:
1000mg Acetaminophen administered orally during preoperative period. Standardized regimen
of Acetaminophen administered during post-surgery (inpatient) period, during
postoperative follow-up period.
Arm group label:
Group 1: NSAID
Arm group label:
Group 2: No-NSAID
Other name:
Tylenol
Intervention type:
Drug
Intervention name:
Oxycodone
Description:
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.
Arm group label:
Group 1: NSAID
Arm group label:
Group 2: No-NSAID
Other name:
Oxycontin
Other name:
Roxicodone
Intervention type:
Drug
Intervention name:
Hydromorphone
Description:
Standardized regimen of Hydromorphone administered intravenously (IV) on demand for
severe pain during post-surgery (inpatient) period.
Arm group label:
Group 1: NSAID
Arm group label:
Group 2: No-NSAID
Other name:
Dihydromorphinone
Other name:
Dilaudid
Other name:
Hydromorph Contin
Other name:
Palladone
Intervention type:
Drug
Intervention name:
Ibuprofen
Description:
400mg Ibuprofen tablets administered orally (PO) every eight (8) hours for 5 days.
Arm group label:
Group 1: NSAID
Other name:
Advil
Other name:
Motrin
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
99 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Miami
Address:
City:
Miami
Zip:
33136
Country:
United States
Status:
Recruiting
Contact:
Last name:
Mark L Gonzalgo, MD
Phone:
305-243-3246
Email:
m.gonzalgo@med.miami.edu
Investigator:
Last name:
Mark L Gonzalgo, MD
Email:
Principal Investigator
Start date:
September 15, 2023
Completion date:
September 30, 2025
Lead sponsor:
Agency:
University of Miami
Agency class:
Other
Source:
University of Miami
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05842044
