Pain Management for Kidney Stone Surgery

Phase 4

Recruiting

Led By Mantu Gupta, MD

Research Sponsored by Icahn School of Medicine at Mount Sinai

Eligibility Criteria Checklist

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

Must have

Undergoing scheduled unilateral standard (24Fr), PCNL with at least 2cm stone burden, with expected single access

Be older than 18 years old

Must not have

Concomitant medications: Other NSAIDs, antiplatelet or anticoagulation medications, probenecid, pentoxifylline

Concomitant medications: Monoamine Oxidase Inhibitors (MAOIs), mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics, diagnosis of chronic pain disorder, reduced sensation of abdomen or pelvis (e.g. patients with spinal cord injury), pre-existing stent or nephrostomy tube, urinary tract anomalies such as urinary diversion, horseshoe kidney, solitary kidney, urinary stricture disease, ureteropelvic junction obstruction, pelvic kidney, stone in calyceal diverticulum, pulmonary disease, liver disease, seizure disorders, subjects taking nephrotoxic medications, subjects taking medications that can increase sedation risk (benzodiazepines or other sedative hypnotics)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up post-op at day 10

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Drug Has Already Been Approved

Summary

This trial compares two pain relief drugs to see which works better for post-op pain relief.

Who is the study for?

This trial is for adults with large kidney stones (at least 2cm) who are scheduled for a specific minimally invasive surgery (PCNL). It's not for pregnant women, those with chronic opioid abuse, NSAID allergies or severe kidney issues, bleeding risks, or on certain medications like blood thinners and MAOIs.

What is being tested?

The study compares two pain relief options after kidney stone surgery: oral ketorolac (a non-opioid painkiller) and oxycodone (an opioid), given as needed every six hours. Patients will be randomly assigned to one of the two drugs to assess effectiveness and safety.

What are the potential side effects?

Ketorolac may cause stomach upset, bleeding problems, or kidney issues. Oxycodone can lead to drowsiness, constipation, addiction risk and respiratory depression. Both drugs have potential side effects that vary from person to person.

Eligibility Criteria

Inclusion Criteria

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

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I am scheduled for a specific kidney stone removal surgery with a large stone.

Exclusion Criteria

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

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I am not taking NSAIDs, blood thinners, probenecid, or pentoxifylline.

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I am not on MAOIs, opioids, have no chronic pain, abnormal sensations, or urinary tract issues, and do not have pulmonary, liver diseases, seizure disorders, nor take nephrotoxic or sedative medications.