NephrolithiasisPhase 4NCT05924165
Narcotic-Free Percutaneous Nephrolithotomy
A Phase 4 study testing 5mg Oxycodone, Q6 PRN and 10mg Ketorolac, Q6 PRN in people with Nephrolithiasis, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
This is a randomized control trial comparing oral ketorolac and opioid medication for the use of post-operative analgesia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nephrolithiasis
- What is being tested?
- 5mg Oxycodone, Q6 PRN and 10mg Ketorolac, Q6 PRN
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 19 May 2023to 7 Jan 2025
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergoing scheduled unilateral standard (24Fr), PCNL with at least 2cm stone burden, with expected single access
Who cannot join
- Pregnant women
- History of chronic opioid abuse
- Allergy, hypersensitivity, or other contraindication to NSAID usage such as
- eGFR < 60 mL/min
- Peptic ulcer disease or history of gastric bypass
- Concurrent use of antiplatelet or anticoagulation therapy (including aspirin)
Show all 31Show fewer
- Thrombocytopenia
- Suspected or confirmed cerebrovascular bleeding, patients with hemorrhagic diathesis, incomplete hemostasis, and those at high risk of bleeding.
- Concomitant medications:
- Other NSAIDs
- Antiplatelet or anticoagulation medications
- Probenecid
- Pentoxifylline
- Allergy, hypersensitivity, or other contraindication to opioids:
- Current opioid prescription/usage for any reason, including active treatment with suboxone or methadone
- Respiratory depression
- Patients with acute or severe bronchial asthma or hypercarbia
- Patients who have or is suspected of having paralytic ileus as PCNL done under general anesthesia
- Patients with hepatic Impairment
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
This is a randomized control trial comparing oral ketorolac and opioid medication for the use of post-operative analgesia.
Read the detailed description
This is a randomized control trial comparing oral ketorolac (10mg, Q6 PRN) and oxycodone (5mg, Q6 PRN) medication for the use of post-operative analgesia after kidney stone removal surgery called percutaneous nephrolithotomy (PCNL). Primary endpoints are visual analog pain scores (VAS) for days 1-5 and day 10 post operatively. Secondary endpoints are pill counts, patient-related outcome survey (PROMIS) scores, emergency room visits, and patient telephone calls. 90 subjects will be enrolled, with 45 in each group.
- Conditions
- Nephrolithiasis
- Being tested
- 5mg Oxycodone, Q6 PRN, 10mg Ketorolac, Q6 PRN
- Medical subject headings
- Nephrolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5mg Oxycodone, Q6 PRNDrug
Oxycodone is an opioid that is used to relieve moderate to severe pain.
10mg Ketorolac, Q6 PRNDrug
Ketorolac is an NSAID used to relieve moderately severe pain.
| Study group | Role | What they receive |
|---|---|---|
| Opioid group | Active comparator | Patients will be prescribed 5mg Oxycodone, Q6 PRN postoperatively. Receives: Drug: 5mg Oxycodone, Q6 PRN |
| NSAID | Active comparator | Patients will be prescribed 10mg Ketorolac, Q6 PRN postoperatively. Receives: Drug: 10mg Ketorolac, Q6 PRN |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS) Pain Scores
Visual Analog Scale (VAS) to measure pain: The minimum score of '0' indicates "no pain" and the maximum score of '10' indicates "Worst pain imaginable" along a line. Participants will be asked to mark the level of their pain along the line. Visual analog scale (VAS) pain scores will be recorded
Measured: post-op day 5 and post-op day 10
Secondary outcomes (4)
Pill Count
A pill count will be conducted of each prescribed postoperative medication.
Measured: post-op at day 10
Number of Participants Who Called the Office
Number of participants with pain related calls to the office recorded.
Measured: post-op up to day 10
Number of Participants With Pain Related Visits
Number of participants with pain related visits to the office or Emergency Department (ED) visits recorded.
Measured: post-op up to day 10
Patient-related Outcome Survey (PROMIS) Scores
Patients given a survey containing questions from Patient-related outcome survey (PROMIS) instruments.
A series of person-centered measures that evaluate and monitor physical, mental, and social health in adults and children. 10-item patient-reported questionnaire. standardized to the general population, using the "T-Score". The average "T-Score" for the United States population is 50 points, with a standard deviation of 10 points. Higher scores indicate a healthier patient.
Measured: post-op at day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2023
- Study start19 May 2023
- Primary completion7 Jan 2025
- Study completion7 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for NephrolithiasisStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mantu Gupta, Icahn School of Medicine at Mount Sinai
- Investigators
- Mantu Gupta, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05924165
- Sponsor's protocol ID
- STUDY-23-00206
- Status last verified
- Mar 2025
- First submitted
- 20 Jun 2023
- Last updated
- 26 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Only aggregate data will be shared
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Narcotic-Free Percutaneous Nephrolithotomy
- ClinicalTrials.gov ID
- NCT05924165
- Acronym / sponsor ID
- STUDY-23-00206
- Conditions
- Nephrolithiasis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 19 May 2023 (actual)
- Primary completion
- 7 Jan 2025 (actual)
- Study completion
- 7 Jan 2025 (actual)
- First posted
- 29 Jun 2023 (actual)
- Results
- Posted 26 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized control trial comparing oral ketorolac and opioid medication for the use of post-operative analgesia.
Detailed description
This is a randomized control trial comparing oral ketorolac (10mg, Q6 PRN) and oxycodone (5mg, Q6 PRN) medication for the use of post-operative analgesia after kidney stone removal surgery called percutaneous nephrolithotomy (PCNL). Primary endpoints are visual analog pain scores (VAS) for days 1-5 and day 10 post operatively. Secondary endpoints are pill counts, patient-related outcome survey (PROMIS) scores, emergency room visits, and patient telephone calls. 90 subjects will be enrolled, with 45 in each group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Opioid group | Active comparator | Drug: 5mg Oxycodone, Q6 PRNPatients will be prescribed 5mg Oxycodone, Q6 PRN postoperatively. |
| NSAID | Active comparator | Drug: 10mg Ketorolac, Q6 PRNPatients will be prescribed 10mg Ketorolac, Q6 PRN postoperatively. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Undergoing scheduled unilateral standard (24Fr), PCNL with at least 2cm stone burden, with expected single access
Key exclusion criteria (31 listed)
- Pregnant women
- History of chronic opioid abuse
- Allergy, hypersensitivity, or other contraindication to NSAID usage such as
- Allergy, hypersensitivity, or other contraindication to opioids:
- Diagnosis of chronic pain disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5mg Oxycodone, Q6 PRNOxycodone is an opioid that is used to relieve moderate to severe pain. | Drug | Opioid group |
| 10mg Ketorolac, Q6 PRNKetorolac is an NSAID used to relieve moderately severe pain. | Drug | NSAID |
Primary outcome
Visual Analog Scale (VAS) Pain Scores
Time frame: post-op day 5 and post-op day 10
Visual Analog Scale (VAS) to measure pain: The minimum score of '0' indicates "no pain" and the maximum score of '10' indicates "Worst pain imaginable" along a line. Participants will be asked to mark the level of their pain along the line. Visual analog scale (VAS) pain scores will be recorded
4 secondary outcomes
Pill Count
Time frame: post-op at day 10
Number of Participants Who Called the Office
Time frame: post-op up to day 10
Number of Participants With Pain Related Visits
Time frame: post-op up to day 10
Patient-related Outcome Survey (PROMIS) Scores
Time frame: post-op at day 10
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Only aggregate data will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mantu Gupta, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 5mg Oxycodone, Q6 PRN and 10mg Ketorolac, Q6 PRN in people with Nephrolithiasis, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) Pain Scores (time frame: post-op day 5 and post-op day 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2025.