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Perioperative Pregabalin in Ureteroscopy: a Pilot

Primary Purpose

Nephrolithiasis, Urolithiasis, Perioperative/Postoperative Complications

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Pregabalin 300mg
Sponsored by
University of Missouri-Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nephrolithiasis focused on measuring Pregabalin, Perioperative medicine, Opioid sparing, Urolithiasis, Ureteroscopy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Missouri-Columbia

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pregabalin 300mg

Arm Description

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

Outcomes

Primary Outcome Measures

Number of Participants With One or More Adverse Events Related to Study Drug
Number of Participants Who Were Administered the Study Drug Correctly
Respondent Reported Usability of Instruments
Number of patients able to complete 30 day post op questionnaire

Secondary Outcome Measures

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.
Early Post-op Opioid Needs
Number of patients with a verified prescription for narcotic medication within the first 30 post-operative days.
Opioid Use
Number of patients stating that they had used opioids on any survey.
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.
Unplanned Healthcare Contacts
Number of unplanned contacts between the patient and the healthcare system. This is the total for all patients.
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.

Full Information

First Posted
April 22, 2019
Last Updated
April 16, 2021
Sponsor
University of Missouri-Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT03927781
Brief Title
Perioperative Pregabalin in Ureteroscopy: a Pilot
Official Title
Perioperative Pregabalin as Part of a Multimodal Treatment Plan for Pain After Ureteroscopy With Stent Placement: a Pilot
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
October 17, 2019 (Actual)
Study Completion Date
October 17, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Missouri-Columbia

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nephrolithiasis, Urolithiasis, Perioperative/Postoperative Complications, Pain, Postoperative, Pain, Acute, Anesthesia, Urologic Diseases, Anesthesia Morbidity
Keywords
Pregabalin, Perioperative medicine, Opioid sparing, Urolithiasis, Ureteroscopy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Model Description
All participants will receive 300mg PO pregabalin one hour before procedure start
Masking
None (Open Label)
Masking Description
There will be no blinding for this pilot
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pregabalin 300mg
Arm Type
Experimental
Arm Description
300mg pregabalin, PO, once, 1 hr before surgery
Intervention Type
Drug
Intervention Name(s)
Pregabalin 300mg
Other Intervention Name(s)
Lyrica, Gabapentinoid
Intervention Description
One 300mg capsule will be administered PO 1 hour before surgery
Primary Outcome Measure Information:
Title
Number of Participants With One or More Adverse Events Related to Study Drug
Time Frame
Day of surgery
Title
Number of Participants Who Were Administered the Study Drug Correctly
Time Frame
Day of surgery
Title
Respondent Reported Usability of Instruments
Description
Number of patients able to complete 30 day post op questionnaire
Time Frame
30 days post-op
Secondary Outcome Measure Information:
Title
Early Post-op Stent Related Symptoms
Description
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.
Time Frame
Post-op day 3
Title
Early Post-op Opioid Needs
Description
Number of patients with a verified prescription for narcotic medication within the first 30 post-operative days.
Time Frame
First 30 post-operative days
Title
Opioid Use
Description
Number of patients stating that they had used opioids on any survey.
Time Frame
Up to 1 year post-op
Title
Amount of Opioid Use
Description
Total amount of opioid used for any indication at several time points, in oral morphine equivalents. This is the sum for all patients.
Time Frame
Up to 1 year post-op
Title
Unplanned Healthcare Contacts
Description
Number of unplanned contacts between the patient and the healthcare system. This is the total for all patients.
Time Frame
First 30 post-operative days
Title
Patient Satisfaction
Description
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.
Time Frame
First 30 post-operative days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katie Murray, DO
Organizational Affiliation
Assistant Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Missouri-Columbia
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Perioperative Pregabalin in Ureteroscopy: a Pilot

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