Randomized Controlled Trial for Ankle Fracture Pain Control
ConditionAnkle Fractures
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-89
SponsorLahey Clinic
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Long-Acting Local Anesthesia
- Regional Anesthesia
Treatment groups
70 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov