Narcotic-Free Percutaneous Nephrolithotomy

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

Study Overview

• Status: Completed
• Conditions: Nephrolithiasis
• Intervention / Treatment: Drug: 5mg Oxycodone, Q6 PRN; Drug: 10mg Ketorolac, Q6 PRN

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 Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10019
      • Mount Sinai West

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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 day 5 and post-op 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 Participants Who Called the Office	Number of participants with pain related calls to the office recorded.	post-op up to day 10
Number of Participants With Pain Related Visits	Number of participants with pain related visits to the office or Emergency Department (ED) visits recorded.	post-op up to day 10
Patient-related Outcome Survey (PROMIS) Scores	Patients 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

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Investigators: Principal Investigator: Mantu Gupta, MD, Icahn School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start (Actual): May 19, 2023
• Primary Completion (Actual): January 7, 2025
• Study Completion (Actual): January 7, 2025

Study Registration Dates

• First Submitted: June 20, 2023
• First Submitted That Met QC Criteria: June 20, 2023
• First Posted (Actual): June 29, 2023

Study Record Updates

• Last Update Posted (Estimated): March 26, 2025
• Last Update Submitted That Met QC Criteria: March 11, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urolithiasis; Urinary Calculi; Kidney Calculi; Nephrolithiasis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Antirheumatic Agents; Central Nervous System Depressants; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Analgesics, Opioid; Narcotics; Anti-Inflammatory Agents, Non-Steroidal; Cyclooxygenase Inhibitors; Ketorolac; Oxycodone
• Other Study ID Numbers: STUDY-23-00206

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Only aggregate data will be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No