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Narcotic-Free Percutaneous Nephrolithotomy

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ClinicalTrials.gov Identifier: NCT05924165
Recruitment Status : Recruiting
First Posted : June 29, 2023
Last Update Posted : May 3, 2024
Sponsor:
Information provided by (Responsible Party):
Mantu Gupta, Icahn School of Medicine at Mount Sinai

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

Condition or disease Intervention/treatment Phase
Nephrolithiasis Drug: 5mg Oxycodone, Q6 PRN Drug: 10mg Ketorolac, Q6 PRN Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Masking Description: Operating surgeon will be blinded to treatment arm intraoperatively (will not be blinded postoperatively)
Primary Purpose: Treatment
Official Title: Narcotic-Free Percutaneous Nephrolithotomy
Actual Study Start Date : May 19, 2023
Estimated Primary Completion Date : May 2025
Estimated Study Completion Date : June 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Visual Analog Scale (VAS) pain scores [ Time Frame: post-op up to day 5 ]
    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

  2. Visual Analog Scale (VAS) pain scores [ Time Frame: post-op at day 10 ]
    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


Secondary Outcome Measures :
  1. Pill count [ Time Frame: post-op at day 10 ]
    A pill count will be conducted of each prescribed postoperative medication.

  2. Number of pain related calls to the office [ Time Frame: post-op up to day 10 ]
    Pain related calls to the office will be recorded.

  3. Number of pain related ED visits [ Time Frame: post-op up to day 10 ]
    Pain related calls to the office and Emergency Department (ED) visits will be recorded.

  4. Patient-related outcome survey (PROMIS) scores [ Time Frame: post-op at day 10 ]

    Patients will be 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.



Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05924165


Contacts
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Contact: Mantu Gupta, MD 2122411272 mantu.gupta@mountsinai.org
Contact: Blair Gallante blair.gallante@mountsinai.org

Locations
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United States, New York
Mount Sinai West Recruiting
New York, New York, United States, 10019
Contact: Mantu Gupta, MD    212-241-1272    mantu.gupta@mountsinai.org   
Principal Investigator: Mantu Gupta         
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Investigators
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Principal Investigator: Mantu Gupta, MD Icahn School of Medicine at Mount Sinai
More Information
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Responsible Party: Mantu Gupta, Professor of Urology, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT05924165    
Other Study ID Numbers: STUDY-23-00206
First Posted: June 29, 2023    Key Record Dates
Last Update Posted: May 3, 2024
Last Verified: May 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Only aggregate data will be shared

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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
Additional relevant MeSH terms:
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Nephrolithiasis
Kidney Calculi
Kidney Diseases
Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Urolithiasis
Male Urogenital Diseases
Urinary Calculi
Calculi
Pathological Conditions, Anatomical
Ketorolac
Oxycodone
 Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action