Who is eligible for clinical trial NCT03696199?

Participants must meet protocol criteria for Ankle Fractures. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT03696199 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2025-11-03

Randomized Controlled Trial for Ankle Fracture Pain Control (NCT03696199)

🟢 Recruiting Phase4 💊 Investigational Drug / Biologic Sponsor: Lahey Clinic

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (2 items) and avoid the listed exclusions (16 items).

Location: Lahey Hospital & Medical Center — Burlington, Massachusetts

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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 practical difficulty of reliably determining the presence of a syndesmotic injury preoperatively Trimalleolar ankle fractures where fixation of the posterior malleolus is not planned will also be included
Isolated Injury

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
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)

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

Lahey Hospital & Medical Center — Burlington, Massachusetts

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗