What side effects are associated with this type of intervention?

Common treatments for kidney stones include ureteroscopy with stent placement, extracorporeal shock wave lithotripsy (ESWL), and medications like alpha-blockers and pain relievers. Ureteroscopy with stent placement can cause discomfort, urinary tract infections, and hematuria. ESWL may lead to bruising, pain, and hematuria. Alpha-blockers can cause dizziness, fatigue, and hypotension. Pregabalin, used for pain management, can cause dizziness, somnolence, dry mouth, and peripheral edema. These side effects should be discussed with a healthcare provider to determine the best treatment plan.

What prior FDA approvals exist?

The FDA has approved various treatments for kidney stones, primarily focusing on pain management and facilitating stone passage. While pregabalin itself is not specifically approved for kidney stones, it is being studied for its potential to reduce pain associated with ureteroscopy and stent placement, which are common procedures for kidney stones. Pregabalin works by binding to the alpha-2-delta subunit of voltage-gated calcium channels, reducing excitatory neurotransmitter release and decreasing pain perception. Other pain management options for kidney stones include NSAIDs and opioids, but these do not share the same mechanism of action as pregabalin.

What other types of research exist?

Promising alternatives to Pregabalin for kidney stone pain management include Gabapentin, which also binds to the alpha-2-delta subunit of voltage-gated calcium channels, and PD-0200347, an alpha-2-delta ligand shown to inhibit pathways involved in pain and inflammation. Additionally, non-pharmacological options like transcutaneous electrical nerve stimulation (TENS) may offer pain relief by modulating pain signals.

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Pregabalin for Postoperative Pain After Ureteroscopy

Q: What is the mechanism of action of this treatment?

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.

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 below

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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.

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I have liver problems.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and within the first 30 days post-operation for reporting.

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 • NCT05053126

Vomiting

Nausea

Headache

100%

80%

60%

40%

20%

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

0 / 6Eligibility criteria met

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.