Perioperative Pregabalin in Ureteroscopy: a Pilot

Perioperative Pregabalin as Part of a Multimodal Treatment Plan for Pain After Ureteroscopy With Stent Placement: a Pilot

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.

Study Overview

• Status: Completed
• Conditions: Urologic Diseases; Pain, Postoperative; Nephrolithiasis; Anesthesia Morbidity; Pain, Acute; Urolithiasis; Anesthesia; Perioperative/Postoperative Complications
• Intervention / Treatment: Drug: Pregabalin 300mg

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Columbia, Missouri, United States, 65212
      • University of Missouri-Columbia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pregabalin 300mg; 300mg pregabalin, PO, once, 1 hr before surgery	Drug: Pregabalin 300mg; One 300mg capsule will be administered PO 1 hour before surgery; Other Names: Lyrica; Gabapentinoid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Early Post-op Stent Related Symptoms	Ureteral Stent Related Symptom Questionnaire (USSQ) score, sum of urinary index score, pain index score, and general health index score. Minimum is 24. Maximum is 162. Higher scores indicate a worse outcome.	Post-op day 3
Early Post-op Opioid Needs	Number of patients with a verified prescription for narcotic medication within the first 30 post-operative days.	First 30 post-operative days
Opioid Use	Number of patients stating that they had used opioids on any survey.	Up to 1 year post-op
Amount of Opioid Use	Total amount of opioid used for any indication at several time points, in oral morphine equivalents. This is the sum for all patients.	Up to 1 year post-op
Unplanned Healthcare Contacts	Number of unplanned contacts between the patient and the healthcare system. This is the total for all patients.	First 30 post-operative days
Patient Satisfaction	Score on standardized evaluation of patient satisfaction at 7-days post-op. This was on a scale from 1) very dissatisfied to 5) very satisfied. Higher scores are better.	First 30 post-operative days

Collaborators and Investigators

• Sponsor: University of Missouri-Columbia
• Investigators: Principal Investigator: Katie Murray, DO, Assistant Professor

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Actual): October 17, 2019
• Study Completion (Actual): October 17, 2020

Study Registration Dates

• First Submitted: April 22, 2019
• First Submitted That Met QC Criteria: April 22, 2019
• First Posted (Actual): April 25, 2019

Study Record Updates

• Last Update Posted (Actual): April 19, 2021
• Last Update Submitted That Met QC Criteria: April 16, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Urolithiasis; Ureteroscopy; Pregabalin; Perioperative medicine; Opioid sparing
• Additional Relevant MeSH Terms: Pathologic Processes; Kidney Diseases; Pain; Neurologic Manifestations; Pathological Conditions, Anatomical; Calculi; Pain, Postoperative; Acute Pain; Postoperative Complications; Urinary Calculi; Urolithiasis; Kidney Calculi; Nephrolithiasis; Urologic Diseases; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Tranquilizing Agents; Psychotropic Drugs; Membrane Transport Modulators; Anti-Anxiety Agents; Anticonvulsants; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Pregabalin
• Other Study ID Numbers: 2013680

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No