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No-PAIN: NSAID Use After Robotic Partial Nephrectomy

Sponsor
University of Miami (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05842044
Collaborator
(none)
110
Enrollment
1
Location
2
Arms
24
Anticipated Duration (Months)
4.6
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
110 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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.
Primary Purpose:
Treatment
Official Title:
NSAID Use After Robotic Partial Nephrectomy (No-PAIN): a Randomized, Controlled Trial
Anticipated Study Start Date :
Jul 31, 2023
Anticipated Primary Completion Date :
Jul 31, 2025
Anticipated Study Completion Date :
Jul 31, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group 1: NSAID

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
15-30mg Ketorolac administered via injection during intraoperative period every six (6) hours during post-surgery (inpatient) period.
Other Names:
  • Ketorolac tromethamine
  • Toradol
  • Biorolac

    • Drug: Acetaminophen
    1000mg Acetaminophen administered orally during preoperative period. Standardized regimen of Acetaminophen administered during post-surgery (inpatient) period, during postoperative follow-up period.
    Other Names:
  • Tylenol

    • 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.
    Other Names:
  • Oxycontin
  • Roxicodone

    • Drug: Hydromorphone
    Standardized regimen of Hydromorphone administered intravenously (IV) on demand for severe pain during post-surgery (inpatient) period.
    Other Names:
  • Dihydromorphinone
  • Dilaudid
  • Hydromorph Contin
  • Palladone

    • Drug: Ibuprofen
    400mg Ibuprofen tablets administered orally (PO) every eight (8) hours for 5 days.
    Other Names:
  • Advil
  • Motrin

    		•
    Active Comparator: Group 2: No-NSAID

    Participants in this group will follow standard of care treatment. Participants will be in this group for approximately 21 days.

    Drug: Acetaminophen
    1000mg Acetaminophen administered orally during preoperative period. Standardized regimen of Acetaminophen administered during post-surgery (inpatient) period, during postoperative follow-up period.
    Other Names:
  • Tylenol

    • 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.
    Other Names:
  • Oxycontin
  • Roxicodone

    • Drug: Hydromorphone
    Standardized regimen of Hydromorphone administered intravenously (IV) on demand for severe pain during post-surgery (inpatient) period.
    Other Names:
  • Dihydromorphinone
  • Dilaudid
  • Hydromorph Contin
  • Palladone

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Rate of Opioid Use in Postoperative Period [Up to 21 days]

      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

    1. Rate of Opioid Medication Use during Hospitalization [Up to 24 hours]

      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.

    2. Pain Score Assessed by Standardized Script [Up to 21 days]

      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.

    3. Pain Score Assessed by International Pain Outcome Questionnaire [Up to 21 days]

      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.

    4. Number of Treatment-Related Adverse Events [Up to 21 days]

      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.

    5. Change in Rate of Acute Kidney Injury [Baseline, Up to 21 days]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Miami Miami Florida United States 33136

    Sponsors and Collaborators

    • University of Miami

    Investigators

    • Principal Investigator: Mark L Gonzalgo, MD, PhD, University of Miami

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mark L. Gonzalgo, MD, PhD, Professor of Clinical, University of Miami
    ClinicalTrials.gov Identifier:
    NCT05842044
    Other Study ID Numbers:
    • 20220783
    First Posted:
    May 3, 2023
    Last Update Posted:
    May 3, 2023
    Last Verified:
    Apr 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by Mark L. Gonzalgo, MD, PhD, Professor of Clinical, University of Miami
    Non-steroidal anti-inflammatory drugs (NSAIDs)
    Additional relevant MeSH terms:
    Kidney Neoplasms
    Acetaminophen
    Ibuprofen
    Ketorolac
    Ketorolac Tromethamine
    Oxycodone
    Hydromorphone

    Study Results

    No Results Posted as of May 3, 2023