Narcotic-Free Percutaneous Nephrolithotomy

NCT05924165 | Completed Phase 4 Results FDA Drug

• 1 other identifier: STUDY-23-00206
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Nephrolithiasis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Pill Count

  post-op at day 10

• Number of Participants Who Called the Office

  post-op up to day 10

• Number of Participants With Pain Related Visits

  post-op up to day 10

• Patient-related Outcome Survey (PROMIS) Scores

  post-op at day 10

Study Arms (2)

Opioid group

ACTIVE COMPARATOR

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

Drug: 5mg Oxycodone, Q6 PRN

NSAID

ACTIVE COMPARATOR

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

Drug: 10mg Ketorolac, Q6 PRN

Interventions

5mg Oxycodone, Q6 PRN DRUG

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

Opioid group

10mg Ketorolac, Q6 PRN DRUG

Ketorolac is an NSAID used to relieve moderately severe pain.

NSAID

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Undergoing scheduled unilateral standard (24Fr), PCNL with at least 2cm stone burden, with expected single access

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Mount Sinai West

New York, New York, 10019, United States

Location

MeSH Terms

Conditions

Nephrolithiasis

Interventions

Oxycodone; Ketorolac

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring

Results Point of Contact

• Title: Dr. Mantu Gupta
• Organization: Icahn School of Medicine at Mount Sinai

Mantu.Gupta@mountsinai.org

(212) 241-1272

Study Officials

• Mantu Gupta, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Operating surgeon will be blinded to treatment arm intraoperatively (will not be blinded postoperatively)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Urology

Study Record Dates

• First Submitted: June 20, 2023
• First Posted: June 29, 2023
• Study Start: May 19, 2023
• Primary Completion: January 7, 2025
• Study Completion: January 7, 2025
• Last Updated: March 26, 2025
• Results First Posted: March 26, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)