Back to resultsNSAID Use After Robotic Partial Nephrectomy (No-PAIN)
Primary Purpose
Kidney Cancer, Renal Cancer, Renal Neoplasm
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ketorolac
Acetaminophen
Oxycodone
Hydromorphone
Ibuprofen
Sponsored by
About this trial
This is an interventional treatment trial for Kidney Cancer focused on measuring Non-steroidal anti-inflammatory drugs (NSAIDs)
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.
Sites / Locations
- University of MiamiRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group 1: NSAID
Group 2: No-NSAID
Arm Description
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.
Participants in this group will follow standard of care treatment. Participants will be in this group for approximately 21 days.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05842044
Brief Title
NSAID Use After Robotic Partial Nephrectomy
Acronym
No-PAIN
Official Title
NSAID Use After Robotic Partial Nephrectomy (No-PAIN): a Randomized, Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 5, 2023 (Actual)
Primary Completion Date
September 5, 2025 (Anticipated)
Study Completion Date
September 5, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Cancer, Renal Cancer, Renal Neoplasm
Keywords
Non-steroidal anti-inflammatory drugs (NSAIDs)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
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.
Allocation
Randomized
Enrollment
110 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group 1: NSAID
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 2: No-NSAID
Arm Type
Active Comparator
Arm Description
Participants in this group will follow standard of care treatment. Participants will be in this group for approximately 21 days.
Intervention Type
Drug
Intervention Name(s)
Ketorolac
Other Intervention Name(s)
Ketorolac tromethamine, Toradol, Biorolac
Intervention Description
15-30mg Ketorolac administered via injection during intraoperative period every six (6) hours during post-surgery (inpatient) period.
Intervention Type
Drug
Intervention Name(s)
Acetaminophen
Other Intervention Name(s)
Tylenol
Intervention Description
1000mg Acetaminophen administered orally during preoperative period. Standardized regimen of Acetaminophen administered during post-surgery (inpatient) period, during postoperative follow-up period.
Intervention Type
Drug
Intervention Name(s)
Oxycodone
Other Intervention Name(s)
Oxycontin, Roxicodone
Intervention 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.
Intervention Type
Drug
Intervention Name(s)
Hydromorphone
Other Intervention Name(s)
Dihydromorphinone, Dilaudid, Hydromorph Contin, Palladone
Intervention Description
Standardized regimen of Hydromorphone administered intravenously (IV) on demand for severe pain during post-surgery (inpatient) period.
Intervention Type
Drug
Intervention Name(s)
Ibuprofen
Other Intervention Name(s)
Advil, Motrin
Intervention Description
400mg Ibuprofen tablets administered orally (PO) every eight (8) hours for 5 days.
Primary Outcome Measure Information:
Title
Rate of Opioid Use in Postoperative Period
Description
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.
Time Frame
Up to 21 days
Secondary Outcome Measure Information:
Title
Rate of Opioid Medication Use during Hospitalization
Description
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.
Time Frame
Up to 24 hours
Title
Pain Score Assessed by Standardized Script
Description
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.
Time Frame
Up to 21 days
Title
Pain Score Assessed by International Pain Outcome Questionnaire
Description
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.
Time Frame
Up to 21 days
Title
Number of Treatment-Related Adverse Events
Description
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.
Time Frame
Up to 21 days
Title
Change in Rate of Acute Kidney Injury
Description
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.
Time Frame
Baseline, Up to 21 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mark L Gonzalgo, MD, PhD
Phone
305-243-3246
Email
m.gonzalgo@med.miami.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark L Gonzalgo, MD, PhD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark L Gonzalgo, MD
Phone
305-243-3246
Email
m.gonzalgo@med.miami.edu
First Name & Middle Initial & Last Name & Degree
Mark L Gonzalgo, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
NSAID Use After Robotic Partial Nephrectomy
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