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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
Must not have
Renal insufficiency (eGFR < 60 mL/minute/1.73 m2)
Liver failure or hepatic dysfunction
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within the first 30 days post-operation
Awards & highlights
All Individual Drugs Already Approved
Approved for 10 Other Conditions
Summary
This trial tests if pregabalin, taken before surgery, can reduce the need for painkillers in patients having a specific type of surgery. Pregabalin works by calming nerve activity to lessen pain and anxiety. Pregabalin is a medication that is effective for treating postoperative pain, nerve pain, anxiety, and blood pressure issues. The study aims to see if this approach can help patients feel less pain after surgery.
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.
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.
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My kidney function is reduced.
Select...
I have liver problems.
Select...
I am scheduled to be admitted to the hospital.
Select...
I regularly use gabapentin or similar medications.
Select...
I cannot give my consent in English by myself.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Visual Analog Scale of Pain Score
Secondary study objectives
Number of Serious Adverse Events
Number of Unplanned Healthcare Interactions
Watson Clock Drawing Test Score
Side effects data
From 2022 Phase 4 trial • 60 Patients • NCT050531265%
Vomiting
3%
Nausea
2%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Lyrica 300mg With Oxycodone 20 mg
Lyrica 450 mg With Oxycodone 20 mg
Lyrica 450 mg
Lyrica 300 mg
Placebo
Oxycodone 20 mg
Awards & Highlights
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.
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
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Pregabalin, a common treatment for managing pain associated with kidney stones, works by binding to the alpha-2-delta subunit of voltage-gated calcium channels. This action reduces the release of excitatory neurotransmitters, thereby decreasing pain perception.
This mechanism is crucial for kidney stone patients as it helps alleviate the significant pain caused by the passage of stones, improving patient comfort and quality of life during treatment.
Modulation of Ca by agents affecting voltage-sensitive Ca channels in mesangial cells.Piperazinyl Bicyclic Derivatives as Selective Ligands of the α2δ-1 Subunit of Voltage-Gated Calcium Channels.Chloride extrusion enhancers as novel therapeutics for neurological diseases.
Modulation of Ca by agents affecting voltage-sensitive Ca channels in mesangial cells.Piperazinyl Bicyclic Derivatives as Selective Ligands of the α2δ-1 Subunit of Voltage-Gated Calcium Channels.Chloride extrusion enhancers as novel therapeutics for neurological diseases.
Find a Location
Who is running the clinical trial?
University of Missouri-ColumbiaLead Sponsor
379 Previous Clinical Trials
628,464 Total Patients Enrolled
1 Trials studying Kidney Stones
10 Patients Enrolled for Kidney Stones
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
1 Trials studying Kidney Stones
10 Patients Enrolled for Kidney Stones
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.