Overview

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.