Randomized Controlled Trial for Ankle Fracture Pain Control

Description

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

Ankle Fractures

Talk to us

Study Overview

On this page

Study Details

Study overview

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.

A Prospective, Randomized Trial Evaluating Regional Anesthesia, Long-Acting Local Anesthesia, and Traditional Care for Pain Control of Operatively Treated Ankle Fractures

Randomized Controlled Trial for Ankle Fracture Pain Control

Condition
Ankle Fractures
Intervention / Treatment

-

Contacts and Locations

Burlington

Lahey Hospital & Medical Center, Burlington, Massachusetts, United States, 01805

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

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 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
  • * 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 subjects (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 English-speaking subjects).
  • * Subjects unable to take the standard post-operative pain regimen that consists of gabapentin, oxycodone, acetaminophen, and ibuprofen.

Ages Eligible for Study

18 Years to 89 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Lahey Clinic,

Eric Swart, MD, PRINCIPAL_INVESTIGATOR, Lahey Hospital & Medical Center

Study Record Dates

2027-09-01