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NSAIDs for Post-Kidney Surgery Pain Management (No-PAIN Trial)

Phase 2

Recruiting

Led By Mark L Gonzalgo, MD, PhD

Research Sponsored by University of Miami

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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)

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 hours

Awards & highlights

No-PAIN Trial Summary

This trial tests if NSAIDs are effective pain relief with no side-effects after robotic kidney surgery.

Who is the study for?

This trial is for adults aged 18-99 undergoing a specific minimally invasive surgery (robotic-assisted laparoscopic partial nephrectomy) for kidney tumors at select locations. Participants must understand and consent to the study's procedures. Excluded are pregnant individuals, those with allergies to NSAIDs, recent heart issues, history of GI complications or bleeding disorders, poor kidney function, or current/recent use of certain blood thinners and opioids.Check my eligibility

What is being tested?

The study aims to evaluate the effectiveness of non-steroidal anti-inflammatory drugs (NSAIDs), such as Ketorolac and Ibuprofen, in managing post-surgery pain compared to other pain relievers like Acetaminophen, Oxycodone, and Hydromorphone after robotic-assisted surgery on renal masses.See study design

What are the potential side effects?

Potential side effects from NSAIDs may include stomach upset or bleeding, allergic reactions, kidney problems especially if used long-term or in high doses. Other pain medications might cause drowsiness, constipation, nausea/vomiting; opioids carry a risk of dependency.

No-PAIN Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am having a specific kidney surgery without complications at a University of Miami Hospital site.

No-PAIN Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Rate of Opioid Use in Postoperative Period

Secondary outcome measures

Change in Rate of Acute Kidney Injury

Number of Treatment-Related Adverse Events

Pain Score Assessed by International Pain Outcome Questionnaire

+2 more

No-PAIN Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Group 1: NSAIDExperimental Treatment5 Interventions

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.

Group II: Group 2: No-NSAIDActive Control3 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ketorolac

2014

Completed Phase 4

~1760

Acetaminophen

2017

Completed Phase 4

~2030

Oxycodone

2014

Completed Phase 4

~2210

Hydromorphone

2005

Completed Phase 4

~4340

Ibuprofen

2013

Completed Phase 4

~5800

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of MiamiLead Sponsor

902 Previous Clinical Trials

409,966 Total Patients Enrolled

Mark L Gonzalgo, MD, PhDPrincipal InvestigatorUniversity of Miami

1 Previous Clinical Trials

88 Total Patients Enrolled

Media Library

Group 1: NSAID Clinical Trial Eligibility Overview. Trial Name: NCT05842044 — Phase 2

Kidney Cancer Research Study Groups: Group 1: NSAID, Group 2: No-NSAID

Kidney Cancer Clinical Trial 2023: Group 1: NSAID Highlights & Side Effects. Trial Name: NCT05842044 — Phase 2

Group 1: NSAID 2023 Treatment Timeline for Medical Study. Trial Name: NCT05842044 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is Group 1: NSAID a safe treatment option for patients?

"The safety of Group 1: NSAID is estimated to be a 2 because there is evidence that it can produce positive outcomes, but the efficacy has yet to be established."

Answered by AI

What qualifications must a patient meet to be eligible for this experiment?

"Patients from the age of majority to 99 are eligible for this trial if they have been diagnosed with kidney cancer. At present, 110 patients are required in order to fulfill the quota."

Answered by AI

Does this research trial encompass those aged 85 or above?

"This medical trial requires that applicants are between 18 and 99 years old. Those younger than eighteen can look for one of the 21 trials specifically designed for minors, while seniors (over 65) may consider any of the 148 programs available to them."

Answered by AI

Are there any vacancies available for potential participants in this trial?

"Unfortunately, this clinical trial is not currently accepting new participants. The study went public on July 31st 2023 and was amended last April 24th, but there are 162 other trials actively searching for volunteers at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

NSAID Use After Robotic Partial Nephrectomy

Mark L. Gonzalgo, MD, PhD 2023. "NSAID Use After Robotic Partial Nephrectomy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05842044.

All > Renal Cancer