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Pregabalin for Postoperative Pain After Ureteroscopy
Phase 2 & 3
Waitlist Available
Led By Katie Murray, DO
Research Sponsored by University of Missouri-Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age >= 18 years
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up in the pre-operative area before medication administration
Awards & highlights
Study Summary
This trial is testing whether the drug pregabalin can reduce the need for pain medication after ureteroscopy with stent placement, by giving it to patients before surgery. The trial is double-blinded, meaning neither the patients nor the staff will know who is receiving the drug or the placebo until after the study is completed.
Who is the study for?
This trial is for adults over 18 who are having elective ureteroscopy with stent placement and can consent in English. It's not for those hospitalized, pregnant, allergic to gabapentinoids, with liver or severe kidney issues, long-term stent use, chronic opioid or gabapentinoid use, or a history of abuse of these substances.Check my eligibility
What is being tested?
The study tests if a single dose of pregabalin before surgery reduces the need for pain meds after ureteroscopy compared to a placebo. Participants won't know which they received until the end and will get gift certificates for survey completion.See study design
What are the potential side effects?
Pregabalin may cause dizziness, sleepiness, blurred vision, weight gain, difficulty concentrating or swelling hands/feet. Not everyone will experience these side effects and they vary from person to person.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within the first 30 days post-operation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within the first 30 days post-operation
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Visual analog scale of pain score
Secondary outcome measures
Number of serious adverse events
Number of unplanned healthcare interactions
Oral morphine equivalents of opioids prescribed
+3 moreOther outcome measures
Baseline Watson clock drawing test score
Baseline visual analog scale of pain score
Side effects data
From 2022 Phase 4 trial • 60 Patients • NCT050531268%
Nausea
5%
COVID-19
5%
Vomiting
100%
80%
60%
40%
20%
0%
Study treatment Arm
Lyrica 450 mg With Oxycodone 20 mg
Lyrica 300 mg
Lyrica 450 mg
Lyrica 300mg With Oxycodone 20 mg
Placebo
Oxycodone 20 mg
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Pregabalin 300mgExperimental Treatment1 Intervention
Patient will receive a compounded version of 300mg pregabalin PO approximately one hour before surgery.
Group II: PlaceboPlacebo Group1 Intervention
Patient will receive a compounded version of inactive placebo PO approximately one hour before surgery.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pregabalin
FDA approved
Find a Location
Who is running the clinical trial?
University of Missouri-ColumbiaLead Sponsor
361 Previous Clinical Trials
627,876 Total Patients Enrolled
Katie Murray, DOPrincipal Investigator - Assistant Professor
Ellis Fischel Cancer Center of University of Missouri, University of Missouri Hospital
2 Previous Clinical Trials
31 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- People who are having a planned procedure to place a stent in their ureter at the University of Missouri Hospital and related facilities.My kidney function is reduced.I have liver problems.I am scheduled to be admitted to the hospital.I regularly use gabapentin or similar medications.You are allergic to gabapentin or similar medications.I am 18 years old or older.You have a history of misusing gabapentin or similar medications.I cannot give my consent in English by myself.You have had a tube in your ureter for more than 30 days in the past year.You regularly use opioids for a long time.You have a history of misusing opioid drugs.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Pregabalin 300mg
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many people have enrolled in this experiment?
"The information available on clinicaltrials.gov does suggest that this particular trial is recruiting patients at the moment. This trial was first posted on June 1st 2020 and received its latest update on October 20th 2021. The aim is to enroll 200 individuals from a single site."
Answered by AI
What are the main indications for Pregabalin 300mg?
"Pregabalin 300mg is a medication typically used to treat fibromyalgia. However, it can also be an effective intervention for anxiety disorders, vitamin b12 deficiency, and issues with the spinal cord."
Answered by AI
Are there still positions available for people who want to participate in this clinical trial?
"The clinical trial, which is currently looking for participants, was originally posted on 6/1/2020. The study has been updated as recently as 10/20/2021 according to the information available on clinicaltrials.gov"
Answered by AI
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