Randomized Controlled Trial for Ankle Fracture Pain Control

• Status: Recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Massachusetts, Worcester
• Collaborator: University of Kentucky
• Treatments: Anesthetics

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.