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Phase 3 N=118 Randomized Quadruple-blind Treatment

Perioperative Pregabalin in Ureteroscopy

Kidney Stone · Pain, Postoperative · Addiction · Opioid Use

Enrolled (actual)
118
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcome: Primary: Visual Analog Scale of Pain Score — 3.7; 2.0 units on a scale

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
Pregabalin 300mg (Drug); Placebo oral tablet (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
University of Missouri-Columbia
Primary completion
Jul 2023

Outcome Measures

OutcomeResultp-value
PRIMARY
Visual Analog Scale of Pain Score
3.7; 2.0
SECONDARY
Oral Morphine Equivalents of Opioids Prescribed
60; 50
SECONDARY
Proportion of Patients With Narcotic Prescription
44; 35
SECONDARY
Number of Unplanned Healthcare Interactions
8; 16
SECONDARY
Number of Serious Adverse Events
0; 0
SECONDARY
Watson Clock Drawing Test Score
1.8; 1.8

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.

Eligibility 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 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04122196). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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