RECRUITING

Randomized Controlled Trial for Ankle Fracture Pain Control

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Conditions

Ankle Fractures

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2020-09-01
Study Completion:2027-09-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03696199

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.

Ages Eligible for Study:18 Years to 89 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * Isolated Injury
  1. * Unifocal malleolar fractures
  2. * Bimalleolar fractures where fixation of only one malleolus is planned
  3. * Posterior malleolus fractures requiring fixation
  4. * Patients ineligible for a peripheral nerve block (e.g. concern for compartment syndrome)
  5. * Open injury
  6. * Patients treated with external fixation
  7. * Neurologic condition that would confound results (e.g. peripheral neuropathy)
  8. * Inability to consent
  9. * Chronic opioid use
  10. * History of opiate abuse
  11. * Polytrauma as defined as additional boney injury, visceral injury or moderate soft tissue injury (requiring suture repair or other invasive procedure)
  12. * Prisoners (unlikely to be accessible for follow-up)
  13. * Pregnant patients
  14. * 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).
  15. * Subjects unable to take the standard post-operative pain regimen that consists of gabapentin, oxycodone, acetaminophen, and ibuprofen.

Contacts and Locations

Study Contact

Eric Swart, MD
CONTACT
781-744-2629
eric.f.swart@lahey.org
Jillian Kazley, MD
CONTACT
781-744-2629
jillian.kazley@lahey.org

Principal Investigator

Eric Swart, MD
PRINCIPAL_INVESTIGATOR
Lahey Hospital & Medical Center

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Lahey Clinic

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-09-01
Study Completion Date2027-09-01

Study Record Updates

Study Start Date2020-09-01
Study Completion Date2027-09-01

Terms related to this study

Additional Relevant MeSH Terms

  • Ankle Fractures