Narcotic-Free Percutaneous Nephrolithotomy

Mount Sinai Health System

Status and phase: Completed; Phase 4

Conditions: Nephrolithiasis

Treatments: Drug: 10mg Ketorolac, Q6 PRN; Drug: 5mg Oxycodone, Q6 PRN

Study type: Interventional

Funder types: Other

Identifiers

NCT05924165

STUDY-23-00206

Details and patient eligibility

About

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

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 2 patient groups

Opioid group

Active Comparator group

Description:

Patients will be prescribed 5mg Oxycodone, Q6 PRN postoperatively.

Treatment:

Drug: 5mg Oxycodone, Q6 PRN

NSAID

Active Comparator group

Description:

Patients will be prescribed 10mg Ketorolac, Q6 PRN postoperatively.

Treatment:

Drug: 10mg Ketorolac, Q6 PRN