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Perioperative Pregabalin in Ureteroscopy: a Pilot

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03927781
Recruitment Status : Active, not recruiting
First Posted : April 25, 2019
Last Update Posted : November 25, 2019
Sponsor:
Information provided by (Responsible Party):
Katie Murray, University of Missouri-Columbia

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 Intervention/treatment Phase
Nephrolithiasis Urolithiasis Perioperative/Postoperative Complications Pain, Postoperative Pain, Acute Anesthesia Urologic Diseases Anesthesia Morbidity Drug: Pregabalin 300mg Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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
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 1, 2019
Actual Primary Completion Date : October 15, 2019
Estimated Study Completion Date : October 15, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Pregabalin

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




Primary Outcome Measures :
  1. Adverse events related to study drug [ Time Frame: Day of surgery ]
    Adverse events related to study drug, mainly in post anesthesia care unit

  2. Administration of study drug [ Time Frame: Day of surgery ]
    Verified correct administration of study drug

  3. Respondent reported usability of instruments [ Time Frame: 30 days post-op ]
    Questionnaire respondent self-report of usability of instrument


Secondary Outcome Measures :
  1. Early post-op stent related symptoms [ Time Frame: Post-op day 3 ]

    Ureteral Stent Related Symptom Questionnaire (USSQ) score.

    Subscores include the following:

    Urinary Index Score (11-57). Higher scores indicates worse outcomes. Pain Index Score (6-30) Higher scores indicates worse outcomes. General Health Index Score (6-30). Higher scores indicates worse outcomes. Work Performance Score (3-15). Higher scores indicates worse outcomes. Sexual Matters( 2-10) Higher scores indicates worse outcomes. Additional Problems with the stent in situ (4-17) Higher scores indicates worse outcomes.

    Global Quality of life with the stent in situ (1-7). Higher scores indicates worse outcomes.


  2. Early post-op opioid needs [ Time Frame: First 30 post-operative days ]
    Monitored prescribing of narcotic pain medication

  3. Opioid use [ Time Frame: Up to 1 year post-op ]
    Opioid use for any indication at several time points

  4. Amount of opioid use [ Time Frame: Up to 1 year post-op ]
    Amount of opioid used for any indication at several time points, in oral morphine equivalents

  5. Unplanned healthcare contacts [ Time Frame: First 30 post-operative days ]
    Number of unplanned contacts between the patient and the healthcare system

  6. Patient satisfaction [ Time Frame: First 30 post-operative days ]
    Score on standardized evaluation of patient satisfaction at various time points. There are two questions graded from very dissatisfied to very satisfied regarding pain related satisfaction and overall satisfaction.



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03927781


Locations
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United States, Missouri
University of Missouri-Columbia
Columbia, Missouri, United States, 65212
Sponsors and Collaborators
University of Missouri-Columbia
Investigators
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Principal Investigator: Katie Murray, DO Assistant Professor
  Study Documents (Full-Text)

Documents provided by Katie Murray, University of Missouri-Columbia:
Study Protocol and Informed Consent Form  [PDF] February 6, 2019
Statistical Analysis Plan  [PDF] November 20, 2019

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Responsible Party: Katie Murray, Assistant Professor, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT03927781    
Other Study ID Numbers: 2013680
First Posted: April 25, 2019    Key Record Dates
Last Update Posted: November 25, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Katie Murray, University of Missouri-Columbia:
Pregabalin
Perioperative medicine
Opioid sparing
Urolithiasis
Ureteroscopy
Additional relevant MeSH terms:
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Urolithiasis
Nephrolithiasis
Kidney Calculi
Urologic Diseases
Pain, Postoperative
Postoperative Complications
Acute Pain
Pathologic Processes
Pain
Neurologic Manifestations
Kidney Diseases
Urinary Calculi
Calculi
Pathological Conditions, Anatomical
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs