Status:
COMPLETED
Perioperative Pregabalin in Ureteroscopy
Lead Sponsor:
University of Missouri-Columbia
Conditions:
Kidney Stone
Pain, Postoperative
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
This is a randomized, placebo-controlled, double-blinded study examining the use of perioperative pregabalin in ureteroscopy with stent placement. Ureteroscopy is typically performed for kidney or ure...
Detailed Description
The prevalence of urolithiasis is greater than 8% and increasing in the United States. For those who require surgery, ureteroscopic treatment is common, representing \>120,000 procedures yearly in the...
Eligibility Criteria
Inclusion
- Subject Inclusion:
- Age \>= 18 years
- Subject Population Undergoing elective ureteroscopy with stent placement at University of Missouri Hospital and affiliated facilities
- Subject Exclusion:
- Renal insufficiency (eGFR \< 60 mL/minute/1.73 m2)
- Chronic indwelling ureteral stent (\>30 days in the previous year)
- Chronic opioid use
- History of opioid abuse
- Chronic gabapentinoid use
- History of gabapentinoid abuse
- Plan for inpatient hospitalization
- Pregnancy
- Inability of the patient to consent for themselves in English
- Allergy to gabapentinoid
- Liver failure or hepatic dysfunction
Exclusion
Key Trial Info
Start Date :
June 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2024
Estimated Enrollment :
118 Patients enrolled
Trial Details
Trial ID
NCT04122196
Start Date
June 1 2020
End Date
July 1 2024
Last Update
November 12 2025
Active Locations (1)
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1
University of Missouri-Columbia
Columbia, Missouri, United States, 65212