Perioperative Pregabalin in Ureteroscopy

• Status: Recruiting
• Trial end date: 2023-07-01
• Target enrollment: 0
• Participant gender: All

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 ureteral stones, but may be performed for other reasons such as for the diagnosis and possible treatment of certain kinds of cancers. As part of the same surgery, a ureteral stent is often placed. The surgery and the stent can cause discomfort, and patients may receive narcotic pain medicine. In other surgeries, a single dose of pregabalin, around one hour before surgery has been shown to decrease the need for pain medication after the surgery. This work will test whether this is true in ureteroscopy by giving eligible patients who agree to participate either pregabalin or a placebo shortly before surgery then examining how much pain medication they use after surgery. A placebo is an inactive medication. Neither the study participant nor the study staff will know who received pregabalin and who received placebo until after the study is over. For completing surveys, patients will receive compensation for their time in the form of gift certificates.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Missouri-Columbia
• Treatments: Pregabalin

Criteria

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