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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post-op at day 10
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am scheduled for a specific kidney stone removal surgery with a large stone.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ post-op at day 10
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post-op at day 10
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Visual Analog Scale (VAS) pain scores
Secondary outcome measures
Number of pain related ED visits
Number of pain related calls to the office
Patient-related outcome survey (PROMIS) scores
+1 moreTrial Design
2Treatment groups
Active Control
Group I: Opioid groupActive Control1 Intervention
Patients will be prescribed 5mg Oxycodone, Q6 PRN postoperatively.
Group II: NSAIDActive Control1 Intervention
Patients will be prescribed 10mg Ketorolac, Q6 PRN postoperatively.
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Who is running the clinical trial?
Icahn School of Medicine at Mount SinaiLead Sponsor
862 Previous Clinical Trials
525,536 Total Patients Enrolled
Mantu Gupta, MDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
1 Previous Clinical Trials
82 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.I cannot take NSAIDs due to allergies, kidney issues, stomach ulcers, bleeding risks, or because I'm on blood thinners.I am not taking NSAIDs, blood thinners, probenecid, or pentoxifylline.I am allergic or have a bad reaction to opioids, or I am currently using opioids.I am scheduled for a specific kidney stone removal surgery with a large stone.You have a history of using opioids for a long time in a way that's not prescribed by a doctor.
Research Study Groups:
This trial has the following groups:- Group 1: Opioid group
- Group 2: NSAID
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many volunteers are participating in this experiment?
"Affirmative. Clinicaltrials.gov exhibits that this research project, which was first listed on May 19th 2023, is actively recruiting volunteers. Approximately 90 patients need to be enrolled from 1 location."
Answered by AI
Are opioid-based medications hazardous to human health?
"Based on the Phase 4 status of this drug, our team concluded that opioids are relatively safe and gave them a score of 3."
Answered by AI
Is there still availability for participation in this experiment?
"Current clinicaltrials.gov information reveals that the research is actively seeking participants, with its initial post date being May 19th 2023 and an edit made as recently as June 20th 23."
Answered by AI
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