Perioperative Pregabalin in Ureteroscopy: a Pilot

NCT03927781 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: 2013680
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Pregabalin; Perioperative medicine; Opioid sparing; Urolithiasis; Ureteroscopy

Outcome Measures

Primary Outcomes (3)

• Number of Participants With One or More Adverse Events Related to Study Drug

  Day of surgery

• Number of Participants Who Were Administered the Study Drug Correctly

  Day of surgery

• Respondent Reported Usability of Instruments

  Number of patients able to complete 30 day post op questionnaire

  30 days post-op

Secondary Outcomes (6)

• Early Post-op Stent Related Symptoms

  Post-op day 3

• Early Post-op Opioid Needs

  First 30 post-operative days

• Opioid Use

  Up to 1 year post-op

• Amount of Opioid Use

  Up to 1 year post-op

• Unplanned Healthcare Contacts

  First 30 post-operative days

Study Arms (1)

Pregabalin 300mg

EXPERIMENTAL

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

Drug: Pregabalin 300mg

Interventions

Pregabalin 300mg DRUG

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

Also known as: Lyrica, Gabapentinoid

Pregabalin 300mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

University of Missouri-Columbia

Columbia, Missouri, 65212, United States

Location

MeSH Terms

Conditions

Nephrolithiasis; Urolithiasis; Postoperative Complications; Pain, Postoperative; Acute Pain; Urologic Diseases

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Kidney Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Dr Katie Murray
• Organization: University of Missouri

murraykat@health.missouri.edu

573-884-8768

Study Officials

• Katie Murray, DO

  Assistant Professor

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Masking Details: There will be no blinding for this pilot
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: All participants will receive 300mg PO pregabalin one hour before procedure start

Study Record Dates

• First Submitted: April 22, 2019
• First Posted: April 25, 2019
• Study Start: April 1, 2019
• Primary Completion: October 17, 2019
• Study Completion: October 17, 2020
• Last Updated: April 19, 2021
• Results First Posted: April 19, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)