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Completed

NCT Number: NCT05924165

Narcotic-Free Percutaneous Nephrolithotomy

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Mount Sinai West

New York, 10019, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

5mg Oxycodone, Q6 PRN

Drug

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

10mg Ketorolac, Q6 PRN

Drug

Ketorolac is an NSAID used to relieve moderately severe pain.

Primary outcomes

  1. Visual Analog Scale (VAS) Pain Scores

    Time frame: post-op day 5 and post-op 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 outcomes

  1. Pill Count

    Time frame: post-op at day 10

    A pill count will be conducted of each prescribed postoperative medication.

  2. Number of Participants Who Called the Office

    Time frame: post-op up to day 10

    Number of participants with pain related calls to the office recorded.

  3. Number of Participants With Pain Related Visits

    Time frame: post-op up to day 10

    Number of participants with pain related visits to the office or Emergency Department (ED) visits recorded.

  4. Patient-related Outcome Survey (PROMIS) Scores

    Time frame: post-op at day 10

    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.

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jun 29, 2023
Registry last updated
Mar 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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