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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

Must not have

Taking any anti-platelet or anti-coagulation medications concurrently (e.g. warfarin, aspirin, clopidogrel, rivaroxaban etc.)

History or active peptic ulcer disease, gastrointestinal (GI) bleeding, GI perforation, or bleeding disorder

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 hours

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently taking blood thinners like warfarin or aspirin.

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I have a history of stomach ulcers, GI bleeding, or a bleeding disorder.

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I have only one kidney.

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I have had surgery to improve blood flow to my heart.

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I am able to understand and agree to the study's requirements.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Rate of Opioid Use in Postoperative Period

Secondary study objectives

Change in Rate of Acute Kidney Injury

Number of Treatment-Related Adverse Events

Pain Score Assessed by International Pain Outcome Questionnaire

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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