Clinical trial NCT05924165: Narcotic-Free Percutaneous Nephrolithotomy
Official title: Narcotic-Free Percutaneous Nephrolithotomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Nephrolithiasis
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2023-06-29
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Visual Analog Scale (VAS) Pain Scores
timeFrame: post-op day 5 and post-op day 10
Secondary outcomes:
measure: Pill Count
timeFrame: post-op at day 10
measure: Number of Participants Who Called the Office
timeFrame: post-op up to day 10
measure: Number of Participants With Pain Related Visits
timeFrame: post-op up to day 10
measure: Patient-related Outcome Survey (PROMIS) Scores
timeFrame: post-op at day 10
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai West
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Mantu Gupta, MD
role: PRINCIPAL_INVESTIGATOR
References: