Narcotic-Free Percutaneous Nephrolithotomy

Nephrolithiasis Clinical Trial

Official title:

Narcotic-Free Percutaneous Nephrolithotomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05924165
• Other study ID #: STUDY-23-00206
• Status: Recruiting
• Phase: Phase 4
• Start date: May 19, 2023
• Est. completion date: June 2025

Study information

• Verified date: May 2024
• Source: Icahn School of Medicine at Mount Sinai
• Contact: Mantu Gupta, MD
• Phone: 2122411272
• Email: mantu.gupta[@]mountsinai.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: June 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Kidney Calculi
• Nephrolithiasis

Intervention

Drug:
• 5mg Oxycodone, Q6 PRN
Oxycodone is an opioid that is used to relieve moderate to severe pain.
• 10mg Ketorolac, Q6 PRN
Ketorolac is an NSAID used to relieve moderately severe pain.

Locations

Country	Name	City	State
United States	Mount Sinai West	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 up to day 5
Primary	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 at day 10
Secondary	Pill count	A pill count will be conducted of each prescribed postoperative medication.	post-op at day 10
Secondary	Number of pain related calls to the office	Pain related calls to the office will be recorded.	post-op up to day 10
Secondary	Number of pain related ED visits	Pain related calls to the office and Emergency Department (ED) visits will be recorded.	post-op up to day 10
Secondary	Patient-related outcome survey (PROMIS) scores	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.	post-op at day 10