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New treatment option for Ankle Fractures
Official title Randomized Controlled Trial for Ankle Fracture Pain Control
ClinicalTrials.gov ID: NCT03696199
What this study is testing
What is Long-Acting Local Anesthesia?
Long-Acting Local Anesthesia is an investigational medicine, being studied as a potential treatment for ankle fractures.
Also referred to as Local Cocktail.
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
- This project is a multicenter, three armed, prospective randomized control trial studying the effectiveness of a long-acting local anesthetic "cocktail" in patients undergoing operative fixation of ankle fractures.
- Phase 4: studies an already-approved treatment
- 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 to 89
You may be able to join if
- Sustained a bimalleolar ankle fracture (OTA/AO type 44 A2, B2, C1, and C2 fracture) with surgery indicated and an approach with medial and lateral...
- Isolated Injury
You likely can't join if
- Unifocal malleolar fractures
- Bimalleolar fractures where fixation of only one malleolus is planned
- Posterior malleolus fractures requiring fixation
- Patients ineligible for a peripheral nerve block (e.g. concern for compartment syndrome)
- Open injury
- Patients treated with external fixation
See the full eligibility criteria
- Sustained a bimalleolar ankle fracture (OTA/AO type 44 A2, B2, C1, and C2 fracture) with surgery indicated and an approach with medial and lateral incisions planned Syndesmotic injuries will be included, due to the...
- Isolated Injury
- Unifocal malleolar fractures
- Bimalleolar fractures where fixation of only one malleolus is planned
- Posterior malleolus fractures requiring fixation
- Patients ineligible for a peripheral nerve block (e.g. concern for compartment syndrome)
- Open injury
- Patients treated with external fixation
- Neurologic condition that would confound results (e.g. peripheral neuropathy)
- Inability to consent
- Chronic opioid use
- History of opiate abuse
- Polytrauma as defined as additional boney injury, visceral injury or moderate soft tissue injury (requiring suture repair or other invasive procedure)
- Prisoners (unlikely to be accessible for follow-up)
- Pregnant patients
- Non-English-speaking people (post-operative data collection procedure involves conversations via phone calls. As we do not have access to translators for this research project, we will work exclusively with...
- people unable to take the standard post-operative pain regimen that consists of gabapentin, oxycodone, acetaminophen, and ibuprofen.
The study team makes the final eligibility decision.
Where it's taking place
- Burlington, Massachusetts, 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 to 89 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Burlington, Massachusetts, 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.