Phase 3
N=10
Perioperative Pregabalin in Ureteroscopy: a Pilot
Nephrolithiasis · Urolithiasis · Perioperative/Postoperative Complications · Pain, Postoperative · Pain, Acute
Bottom Line
View on ClinicalTrials.gov: NCT03927781 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Apr 2021
Primary outcome: Primary: Number of Participants With One or More Adverse Events Related to Study Drug — 6 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Pregabalin 300mg (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Missouri-Columbia
- Primary completion
- Oct 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With One or More Adverse Events Related to Study Drug |
6 | — |
| PRIMARY Number of Participants Who Were Administered the Study Drug Correctly |
10 | — |
| PRIMARY Respondent Reported Usability of Instruments |
5 | — |
| SECONDARY Early Post-op Stent Related Symptoms |
88 | — |
| SECONDARY Early Post-op Opioid Needs |
1 | — |
| SECONDARY Opioid Use |
1 | — |
| SECONDARY Amount of Opioid Use |
90 | — |
| SECONDARY Unplanned Healthcare Contacts |
2 | — |
| SECONDARY Patient Satisfaction |
3.5 | — |
Summary
The investigators propose a pilot clinical trial on the use of perioperative pregabalin in order to decrease ureteral stent related symptoms and decrease opioid usage after ureteroscopy with stent placement. Patients undergoing ureteroscopy with stent placement will receive a single dose of 300 mg pregabalin PO in the preoperative area. This work will assess safety and feasibility of studying this regimen at our institution, with the aim of performing a randomized, placebo-controlled, double-blinded study in the future.
Eligibility Criteria
Subject Population Undergoing elective ureteroscopy with stent placement by Dr. Murray at University of Missouri Hospital and affiliated facilities
Subject Inclusion
Age >= 18 years
Subject Exclusion
- Renal insufficiency (eGFR < 30 mL/minute/1.73 m2)
- Chronic indwelling ureteral stent
- Chronic opioid use
- History of opioid abuse
- Chronic gabapentinoid use
- Plan for inpatient hospitalization
- Pregnancy
- Inability of the patient to consent for themselves in English
- Allergy to gabapentinoid
- Liver failure or hepatic dysfunction
Data sourced from ClinicalTrials.gov (NCT03927781). 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.