Actively Recruiting
Randomized Controlled Trial for Ankle Fracture Pain Control
Led by Lahey Clinic · Updated on 2025-11-06
70
Participants Needed
1
Research Sites
365 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Randomized Controlled Trial for Ankle Fracture Pain Control
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 included
- Trimalleolar ankle fractures without planned posterior malleolus fixation included
- Isolated injury only
You will not qualify if you...
- Unifocal malleolar fractures
- Bimalleolar fractures with fixation planned for only one malleolus
- Posterior malleolus fractures requiring fixation
- Ineligible for peripheral nerve block (e.g., concern for compartment syndrome)
- Open injury
- Treated with external fixation
- Neurologic conditions confounding results (e.g., peripheral neuropathy)
- Inability to consent
- Chronic opioid use
- History of opiate abuse
- Polytrauma (additional bony, visceral, or moderate soft tissue injury requiring invasive procedure)
- Prisoners
- Pregnant patients
- Non-English-speaking subjects
- Unable to take standard post-operative pain regimen (gabapentin, oxycodone, acetaminophen, ibuprofen)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Lahey Hospital & Medical Center
Burlington, Massachusetts, United States, 01805
Actively Recruiting
Research Team
E
Eric Swart, MD
CONTACT
J
Jillian Kazley, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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