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Randomized Controlled Trial for Ankle Fracture Pain Control
RecruitingPhase 4
A Prospective, Randomized Trial Evaluating Regional Anesthesia, Long-Acting Local Anesthesia, and Traditional Care for Pain Control of Operatively Treated Ankle Fractures
Who can join
Ages 18 to 89 · All sexes
Full eligibility criteria
Inclusion 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 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) * 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.
About the study
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.
What is being tested
- Long-Acting Local Anesthesia (drug)
- Regional Anesthesia (drug)
Sponsor: Lahey Clinic · Participants: 70 · Started: Sep 1, 2020
Contact the study team
- Eric Swart, MD · Phone: 781-744-2629
- Jillian Kazley, MD · Phone: 781-744-2629
Official record on ClinicalTrials.gov — NCT03696199
Locations in the U.S.
| Massachusetts | Lahey Hospital & Medical Center, Burlington |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.