Using NSAIDs for pain control after robotic kidney surgery
NSAID Use After Robotic Partial Nephrectomy (No-PAIN): a Randomized, Controlled Trial
PHASE2 · University of Miami · NCT05842044
This study is testing whether common pain relievers can help people manage pain after robotic kidney surgery for cancer.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | University of Miami (other) |
| Locations | 1 site (Miami, Florida) |
| Trial ID | NCT05842044 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of non-steroidal anti-inflammatory drugs (NSAIDs) in managing pain for patients who have undergone robotic-assisted partial nephrectomy for kidney cancer. Participants will receive various pain management medications, including ketorolac and ibuprofen, to determine their efficacy and side effects. The study aims to improve postoperative pain control while minimizing adverse effects associated with traditional pain medications. It is conducted at the University of Miami and its affiliated sites.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-99 undergoing uncomplicated robotic-assisted laparoscopic partial nephrectomy for renal mass.
Not a fit: Patients with allergies to NSAIDs, significant cardiovascular issues, or those with a history of gastrointestinal complications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies for patients recovering from kidney surgery.
How similar studies have performed: Other studies have shown promising results in using NSAIDs for postoperative pain management, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Miami, Florida
- University of Miami — Miami, Florida, United States (RECRUITING)
Study contacts
- Principal investigator: Mark L Gonzalgo, MD, PhD — University of Miami
- Study coordinator: Mark L Gonzalgo, MD, PhD
- Email: m.gonzalgo@med.miami.edu
- Phone: 305-243-3246
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Kidney Cancer, Renal Cancer, Renal Neoplasm, Non-steroidal anti-inflammatory drugs