Actively Recruiting

Phase 4
Age: 18Years - 89Years
All Genders
NCT03696199

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

Age: 18Years - 89Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Lahey Hospital & Medical Center

Burlington, Massachusetts, United States, 01805

Actively Recruiting

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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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Randomized Controlled Trial for Ankle Fracture Pain Control | DecenTrialz