Narcotic-Free Percutaneous Nephrolithotomy

NCT ID: NCT05924165

Last Updated: 2025-03-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-19
• Study Completion Date: 2025-01-07

Brief Summary

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.

Conditions

Nephrolithiasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Opioid group

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

Group Type: ACTIVE_COMPARATOR

5mg Oxycodone, Q6 PRN

Intervention Type: DRUG

Oxycodone is an opioid that is used to relieve moderate to severe pain.

NSAID

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

Group Type: ACTIVE_COMPARATOR

10mg Ketorolac, Q6 PRN

Intervention Type: DRUG

Ketorolac is an NSAID used to relieve moderately severe pain.

Interventions

5mg Oxycodone, Q6 PRN

Oxycodone is an opioid that is used to relieve moderate to severe pain.

Intervention Type: DRUG

10mg Ketorolac, Q6 PRN

Ketorolac is an NSAID used to relieve moderately severe pain.

Intervention Type: DRUG

Eligibility 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:

• 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

Mantu Gupta

Professor of Urology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mantu Gupta, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Mount Sinai West

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

STUDY-23-00206

Identifier Type: -

Identifier Source: org_study_id