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Perioperative Pregabalin in Ureteroscopy: a Pilot

  • Clinicaltrials.gov identifier

    NCT03927781

  • Recruitment Status

    Completed

  • First Posted

    April 25, 2019

  • Result First Posted

    April 19, 2021

  • Last update posted

    April 19, 2021

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.

  • Condition or Disease:Nephrolithiasis
    Urolithiasis
    Perioperative/Postoperative Complications
    Anesthesia Morbidity
    Pain, Acute
    Pain, Postoperative
    Urologic Diseases
    Anesthesia
  • Intervention/Treatment: Drug: Pregabalin 300mg
  • Phase: Phase 3

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Actual Enrollment: 10 participants
  • Intervention Model: Single Group Assignment
  • Intervention Model Description: All participants will receive 300mg PO pregabalin one hour before procedure start
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: Perioperative Pregabalin as Part of a Multimodal Treatment Plan for Pain After Ureteroscopy With Stent Placement: a Pilot
  • Actual Study Start Date: April 2019
  • Actual Primary Completion Date: October 2019
  • Actual Study Completion Date: October 2020

Arms and interventions

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

Outcome Measures

  • Primary Outcome Measures: 1. Number of Participants With One or More Adverse Events Related to Study Drug [ Time Frame: Day of surgery ]
  • 2. Number of Participants Who Were Administered the Study Drug Correctly [ Time Frame: Day of surgery ]
  • 3. Respondent Reported Usability of Instruments [ Time Frame: 30 days post-op ]
    Number of patients able to complete 30 day post op questionnaire
  • Secondary Outcome Measures: 1. Early Post-op Stent Related Symptoms [ Time Frame: Post-op day 3 ]
    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.
  • 2. Early Post-op Opioid Needs [ Time Frame: First 30 post-operative days ]
    Number of patients with a verified prescription for narcotic medication within the first 30 post-operative days.
  • 3. Opioid Use [ Time Frame: Up to 1 year post-op ]
    Number of patients stating that they had used opioids on any survey.
  • 4. Amount of Opioid Use [ Time Frame: Up to 1 year post-op ]
    Total amount of opioid used for any indication at several time points, in oral morphine equivalents. This is the sum for all patients.
  • 5. Unplanned Healthcare Contacts [ Time Frame: First 30 post-operative days ]
    Number of unplanned contacts between the patient and the healthcare system. This is the total for all patients.
  • 6. Patient Satisfaction [ Time Frame: First 30 post-operative days ]
    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.

Eligibility Criteria

  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Locations

United States, Missouri
University of Missouri-Columbia
Columbia

Sponsors and Collaborators

University of Missouri-Columbia

Investigators

Principal Investigator: Katie Murray, DO Assistant Professor

More Information

  • Responsible Party: University of Missouri-Columbia
  • ClinicalTrials.gov Identifier: NCT03927781 History of Changes
  • Other Study ID Numbers: 2013680
  • First Posted: April 25, 2019 Key Record Dates
  • Last Update Posted: April 19, 2021
  • Last Verified: April 2021
  • Individual Participant
    Data (IPD) Sharing
    Statement:

  • Plan to Share IPD: No
  • 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.: Yes
  • Keywords provided by University of Missouri-Columbia: Pregabalin
    Perioperative medicine
    Opioid sparing
    Urolithiasis
    Ureteroscopy
  • Additional relevant MeSH terms: Urolithiasis
    Nephrolithiasis
    Kidney Calculi
    Urologic Diseases
    Pain, Postoperative
    Postoperative Complications
    Acute Pain
  • Study Type: Interventional
  • Study Design: Allocation: N/A;Intervention Model: Single Group Assignment;Masking: None (Open Label);Primary Purpose: Treatment
  • Condition: Nephrolithiasis
    Urolithiasis
    Perioperative/Postoperative Complications
    Anesthesia Morbidity
    Pain, Acute
    Pain, Postoperative
    Urologic Diseases
    Anesthesia
  • Interventions : Drug: Pregabalin 300mg
  • Enrollment: 10

Participant flow

  • Recruitment Details
  • Pre-assignment Details

  • Arm/Group title Pregabalin 300mg
  • Arm/Group Description 300mg pregabalin, PO, once, 1 hr before surgery Pregabalin 300mg: One 300mg capsule will be administered PO 1 hour before surgery
    Period Title: Overall Study
  • Started 10
  • Completed 10
  • Not Completed 0
  • Reason Not Completed
Baseline Characteristics
  • Arm/Group title Pregabalin 300mg
  • Arm/Group Description 300mg pregabalin, PO, once, 1 hr before surgery Pregabalin 300mg: One 300mg capsule will be administered PO 1 hour before surgery
  • Overall Number of Baseline Participants 10
  • Baseline Analysis Population Description [Not Specified]
  • Region of Enrollment Measure Type: Count of Participants Unit of Measure: Participants Number Analyzed 10 Participants
Outcome Measures

1. PrimaryOutcome

  • Title Respondent Reported Usability of Instruments
  • Description Number of patients able to complete 30 day post op questionnaire
  • Time Frame 30 days post-op
Outcome Measure Data
  • Analysis Population Description [Not Specified]
  •  
  • Arm/Group title Pregabalin 300mg
  • Arm/Group Description 300mg pregabalin, PO, once, 1 hr before surgery Pregabalin 300mg: One 300mg capsule will be administered PO 1 hour before surgery
  • Overall Number of Participants Analyzed 10
  • Measure Type: Count of Participants
    Unit of Measure: Participants
  • 5

2. PrimaryOutcome

  • Title Number of Participants Who Were Administered the Study Drug Correctly
  • Description
  • Time Frame Day of surgery
Outcome Measure Data
  • Analysis Population Description [Not Specified]
  •  
  • Arm/Group title Pregabalin 300mg
  • Arm/Group Description 300mg pregabalin, PO, once, 1 hr before surgery Pregabalin 300mg: One 300mg capsule will be administered PO 1 hour before surgery
  • Overall Number of Participants Analyzed 10
  • Measure Type: Count of Participants
    Unit of Measure: Participants
  • 10

3. PrimaryOutcome

  • Title Number of Participants With One or More Adverse Events Related to Study Drug
  • Description
  • Time Frame Day of surgery
Outcome Measure Data
  • Analysis Population Description [Not Specified]
  •  
  • Arm/Group title Pregabalin 300mg
  • Arm/Group Description 300mg pregabalin, PO, once, 1 hr before surgery Pregabalin 300mg: One 300mg capsule will be administered PO 1 hour before surgery
  • Overall Number of Participants Analyzed 10
  • Measure Type: Count of Participants
    Unit of Measure: Participants
  • 6

4. SecondaryOutcome

  • 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
Outcome Measure Data
  • Analysis Population Description Respondents to the survey
  •  
  • Arm/Group title Pregabalin 300mg
  • Arm/Group Description 300mg pregabalin, PO, once, 1 hr before surgery Pregabalin 300mg: One 300mg capsule will be administered PO 1 hour before surgery
  • Overall Number of Participants Analyzed 6
  • Measure Type: Mean (Full Range)
    Unit of Measure: score on a scale
  • 3.5
    (1.0 to 5.0)

5. SecondaryOutcome

  • 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
Outcome Measure Data
  • Analysis Population Description [Not Specified]
  •  
  • Arm/Group title Pregabalin 300mg
  • Arm/Group Description 300mg pregabalin, PO, once, 1 hr before surgery Pregabalin 300mg: One 300mg capsule will be administered PO 1 hour before surgery
  • Overall Number of Participants Analyzed 10
  • Measure Type: Number
    Unit of Measure: visits
  • 2

6. SecondaryOutcome

  • 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
Outcome Measure Data
  • Analysis Population Description [Not Specified]
  •  
  • Arm/Group title Pregabalin 300mg
  • Arm/Group Description 300mg pregabalin, PO, once, 1 hr before surgery Pregabalin 300mg: One 300mg capsule will be administered PO 1 hour before surgery
  • Overall Number of Participants Analyzed 10
  • Measure Type: Number
    Unit of Measure: oral morphine equivalents
  • 90

7. SecondaryOutcome

  • Title Opioid Use
  • Description Number of patients stating that they had used opioids on any survey.
  • Time Frame Up to 1 year post-op
Outcome Measure Data
  • Analysis Population Description [Not Specified]
  •  
  • Arm/Group title Pregabalin 300mg
  • Arm/Group Description 300mg pregabalin, PO, once, 1 hr before surgery Pregabalin 300mg: One 300mg capsule will be administered PO 1 hour before surgery
  • Overall Number of Participants Analyzed 10
  • Measure Type: Count of Participants
    Unit of Measure: Participants
  • 1

8. SecondaryOutcome

  • 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
Outcome Measure Data
  • Analysis Population Description [Not Specified]
  •  
  • Arm/Group title Pregabalin 300mg
  • Arm/Group Description 300mg pregabalin, PO, once, 1 hr before surgery Pregabalin 300mg: One 300mg capsule will be administered PO 1 hour before surgery
  • Overall Number of Participants Analyzed 10
  • Measure Type: Count of Participants
    Unit of Measure: Participants
  • 1

9. SecondaryOutcome

  • 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
Outcome Measure Data
  • Analysis Population Description Those who completed the questionnaire
  •  
  • Arm/Group title Pregabalin 300mg
  • Arm/Group Description 300mg pregabalin, PO, once, 1 hr before surgery Pregabalin 300mg: One 300mg capsule will be administered PO 1 hour before surgery
  • Overall Number of Participants Analyzed 5
  • Measure Type: Mean (Full Range)
    Unit of Measure: score on a scale
  • 88
    (61.0 to 130.0)
Adverse Events
  • Time Frame Events were systematically characterized on the day of surgery. Adverse events were otherwise by report up to 30 days after the patient's procedure.
  • Adverse Event Reporting Description [Not Specified]
  •  
  • Arm/Group Title Pregabalin 300mg
  • Arm/Group Description 300mg pregabalin, PO, once, 1 hr before surgery Pregabalin 300mg: One 300mg capsule will be administered PO 1 hour before surgery

Show Other (Not Including Serious) Adverse Events

  • Pregabalin 300mg
  • Affected at Risk (%)
  • Total 1/10 (10.00%)
  • Gastrointestinal disorders
  • Dry mouth 6 /10 (60.00%)
  • Increased appetite 1 /10 (10.00%)
  • Nervous system disorders
  • Dizziness 1 /10 (10.00%)
  • Blurred vision 1 /10 (10.00%)
  • Somnolence 1 /10 (10.00%)
  • Confusion 1 /10 (10.00%)
  • Fatigue 1 /10 (10.00%)
  • Back pain 1 /10 (10.00%)
  • Pain 3 /10 (30.00%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

  • ClinicalTrials.gov Identifier: NCT03927781 History of Changes
  • Other Study ID Numbers: 2013680
  • First Submitted: April 22, 2019
  • First Posted: April 25, 2019
  • Results First Submitted: February 27, 2021
  • Results First Posted: April 19, 2021
  • Last Update Posted: April 19, 2021