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Tests treatment safety and results for Total Ankle Arthroplasty
Official title Efficacy of EXPAREL vs. Bupivacaine
ClinicalTrials.gov ID: NCT07212114
What this study is testing
What is EXPAREL?
EXPAREL is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for total ankle arthroplasty.
Also referred to as bupivacaine liposome injectable suspension.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical study is to learn about pain management strategies in subjects undergoing total ankle replacement. arthroplasty surgery The primary objective is to compare the magnitude of the analgesic effect following a single dose injection of EXPAREL vs.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Indicated to undergo unilateral total ankle arthroplasty
- American Society of Anesthesiologists (ASA) physical status 1, 2, or 3
- Able to provide informed consent, adhere to the study schedule, and complete all study assessments
- Body Mass Index (BMI) ≥18 and ≤40 kg/m2
You likely can't join if
- Allergy, hypersensitivity, intolerance, or contraindication to any of the study medications for which an alternative is not named in the protocol...
- Concurrent painful physical condition that may require analgesic treatment (such as long-term, consistent use of opioids) in the post-dosing period...
- History of, suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years
- Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the Investigator, could interfere with study assessments...
- Currently pregnant, nursing, or planning to become pregnant during the study
- History of contralateral ankle arthroplasty within 1 year
See the full eligibility criteria
- Indicated to undergo unilateral total ankle arthroplasty
- American Society of Anesthesiologists (ASA) physical status 1, 2, or 3
- Able to provide informed consent, adhere to the study schedule, and complete all study assessments
- Body Mass Index (BMI) ≥18 and ≤40 kg/m2
- Allergy, hypersensitivity, intolerance, or contraindication to any of the study medications for which an alternative is not named in the protocol (e.g., amide-type local anesthetics, opioids, bupivacaine HCl, NSAIDs)
- Concurrent painful physical condition that may require analgesic treatment (such as long-term, consistent use of opioids) in the post-dosing period for pain, and which, in the Investigator's opinion, may confound the...
- History of, suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years
- Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the Investigator, could interfere with study assessments or compliance
- Currently pregnant, nursing, or planning to become pregnant during the study
- History of contralateral ankle arthroplasty within 1 year
- people that require ankle arthroplasty due to failed prior ankle arthrodesis
- people with avascular necrosis of the talus
- people undergoing revision total ankle arthroplasty
- Clinically significant medical disease that, in the opinion of the Investigator, would make participation in a clinical study inappropriate. This includes diabetic neuropathy, coagulation or bleeding disorders, severe...
- Chronic opioid use within 30 days before randomization (average ≥30 oral morphine equivalents/day
- Prisoners
- Cognitive impairment or impaired decision-making capacity
- Inability to communicate in English
The study team makes the final eligibility decision.
Where it's taking place
- Atlanta, Georgia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Atlanta, Georgia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.