Narcotic-Free Percutaneous Nephrolithotomy

Phase 4

Completed

Conditions: Nephrolithiasis

Interventions: Drug: 5mg Oxycodone, Q6 PRN
Drug: 10mg Ketorolac, Q6 PRN

Registration Number: NCT05924165

Lead Sponsor: Icahn School of Medicine at Mount Sinai

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 90

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Opioid group	5mg Oxycodone, Q6 PRN	Patients will be prescribed 5mg Oxycodone, Q6 PRN postoperatively.
NSAID	10mg Ketorolac, Q6 PRN	Patients will be prescribed 10mg Ketorolac, Q6 PRN postoperatively.

Primary Outcome Measures

Name	Time	Method
Visual Analog Scale (VAS) Pain Scores	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 Outcome Measures

Name	Time	Method
Pill Count	post-op at day 10	A pill count will be conducted of each prescribed postoperative medication.
Number of Participants Who Called the Office	post-op up to day 10	Number of participants with pain related calls to the office recorded.
Number of Participants With Pain Related Visits	post-op up to day 10	Number of participants with pain related visits to the office or Emergency Department (ED) visits recorded.
Patient-related Outcome Survey (PROMIS) Scores	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.