NSAID Use After Robotic Partial Nephrectomy

Study Overview
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Brief Summary
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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.

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

Conditions
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Kidney Cancer, Renal Cancer, Renal Neoplasm

Intervention / Treatment
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* Drug: Ketorolac
* Drug: Acetaminophen
* Drug: Oxycodone
* Drug: Hydromorphone
* Drug: Ibuprofen


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1: NSAID<br>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. | Drug: Ketorolac<br>* 15-30mg Ketorolac administered via injection during intraoperative period every six (6) hours during post-surgery (inpatient) period.<br>* Other names: Biorolac;Drug: Acetaminophen<br>* 1000mg Acetaminophen administered orally during preoperative period. Standardized regimen of Acetaminophen administered during post-surgery (inpatient) period, during postoperative follow-up period.<br>* Other names: Tylenol;Drug: Oxycodone<br>* 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.<br>* Other names: Roxicodone;Drug: Hydromorphone<br>* Standardized regimen of Hydromorphone administered intravenously (IV) on demand for severe pain during post-surgery (inpatient) period.<br>* Other names: Palladone;Drug: Ibuprofen<br>* 400mg Ibuprofen tablets administered orally (PO) every eight (8) hours for 5 days.<br>* Other names: Motrin;|
| Active Comparator: Group 2: No-NSAID<br>Participants in this group will follow standard of care treatment. Participants will be in this group for approximately 21 days. | Drug: Acetaminophen<br>* 1000mg Acetaminophen administered orally during preoperative period. Standardized regimen of Acetaminophen administered during post-surgery (inpatient) period, during postoperative follow-up period.<br>* Other names: Tylenol;Drug: Oxycodone<br>* 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.<br>* Other names: Roxicodone;Drug: Hydromorphone<br>* Standardized regimen of Hydromorphone administered intravenously (IV) on demand for severe pain during post-surgery (inpatient) period.<br>* Other names: Palladone;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Opioid Use in Postoperative Period | Rate of opioid use is defined as the number of participants who used opioid medications during the post-operative period (defined as end of surgery to post-operative follow up visit) divided by total number of participants in the group at postoperative visit. | Up to 20 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Opioid Medication Use during Hospitalization | Rate of opioid medication use among study participants during hospitalization, defined as the number of participants who use opioid medication divided by total number of participants in the group during the time between surgery and discharge. | Up to 24 hours | 
| Pain Score Assessed by Standardized Script | At 24 hours post-surgery and during the postoperative follow-up period, pain score will be elicited from study participants using a standardized script, and scored on scale of 0 to 10, with 0 being no pain and 10 being the worst pain. | Up to 20 days | 
| Pain Score Assessed by International Pain Outcome Questionnaire | Participants will complete the International Pain Outcome questionnaire during the postoperative and follow-up periods. Scores range from 0 to 10, with higher scores indicating more pain. | Up to 20 days | 
| Number of Treatment-Related Adverse Events | The number of treatment-related of adverse events among study participants will be assessed by treating physician, post-surgery and after discharge during the postoperative period. | Up to 20 days | 
| Change in Rate of Acute Kidney Injury | Rate of acute kidney injury at postoperative follow-up visit. Acute kidney injury is defined as a rise of Creatinine greater than (>) 0.3 from baseline. | Baseline, Up to 20 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-steroidal anti-inflammatory drugs (NSAIDs)