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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/21/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/21/2021.

Perioperative Pregabalin in Ureteroscopy: a Pilot

Clinicaltrials.gov identifier NCT03927781

Recruitment Status Active, not recruiting

First Posted April 25, 2019

Last update posted November 25, 2019

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:Pain, Postoperative
    Pain, Acute
    Anesthesia
    Urologic Diseases
    Anesthesia Morbidity
    Nephrolithiasis
    Urolithiasis
    Perioperative/Postoperative Complications
  • 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
  • Estimated 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. 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. 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
  • 2. 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.
  • 3. Early post-op opioid needs [ Time Frame: First 30 post-operative days ]
    Monitored prescribing of narcotic pain medication
  • 4. Opioid use [ Time Frame: Up to 1 year post-op ]
    Opioid use for any indication at several time points
  • 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.
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: November 25, 2019
  • Last Verified: November 2019
  • 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: Opioid sparing
    Urolithiasis
    Ureteroscopy
    Pregabalin
    Perioperative medicine
  • Additional relevant MeSH terms: Urolithiasis
    Nephrolithiasis
    Pain, Postoperative
    Postoperative Complications
    Kidney Calculi
    Urologic Diseases
    Acute Pain