Perioperative Pregabalin in Ureteroscopy: a Pilot

NCT ID: NCT03927781

Last Updated: 2021-04-19

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-01

Study Completion Date

2020-10-17

Brief Summary

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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.

Detailed Description

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Conditions

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Nephrolithiasis Urolithiasis Perioperative/Postoperative Complications Pain, Postoperative Pain, Acute Anesthesia Urologic Diseases Anesthesia Morbidity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

All participants will receive 300mg PO pregabalin one hour before procedure start
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

There will be no blinding for this pilot

Study Groups

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Pregabalin 300mg

300mg pregabalin, PO, once, 1 hr before surgery

Group Type EXPERIMENTAL

Pregabalin 300mg

Intervention Type DRUG

One 300mg capsule will be administered PO 1 hour before surgery

Interventions

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Pregabalin 300mg

One 300mg capsule will be administered PO 1 hour before surgery

Intervention Type DRUG

Other Intervention Names

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Lyrica Gabapentinoid

Eligibility Criteria

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Inclusion Criteria

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Missouri-Columbia

OTHER

Sponsor Role lead

Responsible Party

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Katie Murray

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Katie Murray, DO

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor

Locations

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University of Missouri-Columbia

Columbia, Missouri, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Informed Consent Form

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2013680

Identifier Type: -

Identifier Source: org_study_id

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