Narcotic-Free Percutaneous Nephrolithotomy

Description

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

Trial Eligibility

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)

Study Info

Interventions

Locations Recruiting

Interested in joining this trial?

Our dedicated patient navigators are here to guide you through the validation and enrollment process with ease.