Narcotic-Free Percutaneous Nephrolithotomy

Study Overview
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Brief Summary
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This is a randomized control trial comparing oral ketorolac and opioid medication for the use of post-operative analgesia.

Detailed Description
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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.

Official Title
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Narcotic-Free Percutaneous Nephrolithotomy

Conditions
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Nephrolithiasis

Intervention / Treatment
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* Drug: 5mg Oxycodone, Q6 PRN
* Drug: 10mg Ketorolac, Q6 PRN


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Undergoing scheduled unilateral standard (24Fr), PCNL with at least 2cm stone burden, with expected single access Exclusion Criteria: 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) 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Opioid group<br>Patients will be prescribed 5mg Oxycodone, Q6 PRN postoperatively. | Drug: 5mg Oxycodone, Q6 PRN<br>* Oxycodone is an opioid that is used to relieve moderate to severe pain.<br>|
| Active Comparator: NSAID<br>Patients will be prescribed 10mg Ketorolac, Q6 PRN postoperatively. | Drug: 10mg Ketorolac, Q6 PRN<br>* Ketorolac is an NSAID used to relieve moderately severe pain.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | post-op up to day 5 | 
| 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 | post-op at day 10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pill count | A pill count will be conducted of each prescribed postoperative medication. | post-op at day 10 | 
| Number of pain related calls to the office | Pain related calls to the office will be recorded. | post-op up to day 10 | 
| Number of pain related ED visits | Pain related calls to the office and Emergency Department (ED) visits will be recorded. | post-op up to day 10 | 
| Patient-related outcome survey (PROMIS) scores | Patients will be 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. | post-op at day 10 |