Narcotic-Free Percutaneous Nephrolithotomy
Study Details
Study Description
Brief Summary
This is a randomized control trial comparing oral ketorolac and opioid medication for the use of post-operative analgesia.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Opioid group Patients will be prescribed 5mg Oxycodone, Q6 PRN postoperatively. |
Drug: 5mg Oxycodone, Q6 PRN
Oxycodone is an opioid that is used to relieve moderate to severe pain.
|
| Active Comparator: NSAID Patients will be prescribed 10mg Ketorolac, Q6 PRN postoperatively. |
Drug: 10mg Ketorolac, Q6 PRN
Ketorolac is an NSAID used to relieve moderately severe pain.
|
Outcome Measures
Primary Outcome Measures
- Visual Analog Scale (VAS) pain scores [post-op up to day 5]
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
- Visual Analog Scale (VAS) pain scores [post-op at 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
Secondary Outcome Measures
- Pill count [post-op at day 10]
A pill count will be conducted of each prescribed postoperative medication.
- Number of pain related calls to the office [post-op up to day 10]
Pain related calls to the office will be recorded.
- Number of pain related ED visits [post-op up to day 10]
Pain related calls to the office and Emergency Department (ED) visits will be recorded.
- Patient-related outcome survey (PROMIS) scores [post-op at day 10]
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.
Eligibility Criteria
Criteria
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:
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Other NSAIDs
-
Antiplatelet or anticoagulation medications
-
Probenecid
-
Pentoxifylline
-
Allergy, hypersensitivity, or other contraindication to opioids:
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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
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Patients who have or is suspected of having paralytic ileus as PCNL done under general anesthesia
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Patients with hepatic Impairment
-
Concomitant medications:
-
Monoamine Oxidase Inhibitors (MAOIs)
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Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics
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Diagnosis of chronic pain disorder
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Reduced sensation of abdomen or pelvis (e.g. patients with spinal cord injury)
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Pre-existing stent or nephrostomy tube
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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
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Subjects taking nephrotoxic medications
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Subjects taking medications that can increase sedation risk (benzodiazepines or other sedative hypnotics)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mount Sinai West | New York | New York | United States | 10019 |
Sponsors and Collaborators
- Icahn School of Medicine at Mount Sinai
Investigators
- Principal Investigator: Mantu Gupta, MD, Icahn School of Medicine at Mount Sinai
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- STUDY-23-00206