Randomized Controlled Trial for Ankle Fracture Pain Control

Launched by LAHEY CLINIC · Oct 3, 2018

Keywords

ClinConnect Summary

This clinical trial is exploring a new way to manage pain after surgery for ankle fractures. The researchers want to see if a special combination of long-acting local anesthetics can help control pain better than standard methods in patients who need surgery for certain types of ankle fractures. The trial is open to both men and women aged between 18 and 80 who have suffered specific types of bimalleolar ankle fractures and are scheduled for surgery.

Participants in the trial can expect to receive either the new pain control treatment or standard care during their surgery. It's important to note that there are specific criteria to join the study, such as having an isolated bimalleolar ankle fracture that requires surgical repair. Certain individuals, like those with more complex injuries, chronic pain issues, or who are not fluent in English, will not be eligible to participate. If you qualify and choose to join, you will help researchers learn more about effective pain management in ankle surgeries, potentially benefiting future patients.

Gender

ALL

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.