RECRUITING

NSAID Use After Robotic Partial Nephrectomy

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Conditions

Kidney CancerRenal CancerRenal NeoplasmNon-steroidal anti-inflammatory drugs (NSAIDs)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-09-15
Study Completion:2025-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05842044

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 99 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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).
  2. * Age 18-99.
  3. * Ability to understand and the willingness to sign a written informed consent document.
  1. * Allergy to NSAIDs
  2. * Myocardial infarction or unstable angina within 12 months.
  3. * Any history of coronary artery bypass graft surgery.
  4. * 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).
  5. * Taking any anti-platelet or anti-coagulation medications concurrently (e.g. warfarin, aspirin, clopidogrel, rivaroxaban etc.)
  6. * Chronic opioid use (use within 12 weeks) or history of opioid use disorder.
  7. * Solitary kidney.
  8. * Pregnancy.
  9. * Inability to give informed consent or unable to meet requirement of the study for any reason.

Contacts and Locations

Study Contact

Mark L Gonzalgo, MD, PhD
CONTACT
305-243-3246
m.gonzalgo@med.miami.edu

Principal Investigator

Mark L Gonzalgo, MD, PhD
PRINCIPAL_INVESTIGATOR
University of Miami

Study Locations (Sites)

University of Miami
Miami, Florida, 33136
United States

Collaborators and Investigators

Sponsor: University of Miami

  • Mark L Gonzalgo, MD, PhD, PRINCIPAL_INVESTIGATOR, University of Miami

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-15
Study Completion Date2025-09-30

Study Record Updates

Study Start Date2023-09-15
Study Completion Date2025-09-30

Terms related to this study

Keywords Provided by Researchers

  • Non-steroidal anti-inflammatory drugs (NSAIDs)

Additional Relevant MeSH Terms

  • Kidney Cancer
  • Renal Cancer
  • Renal Neoplasm