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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

Long-Acting Local Anesthesia
Drug
The cocktail consists of: * 0.5% Ropivicaine, 24.6 mL * Clonidine 100 mcg/mL, 0.4mL * Epinephrine 1mg/mL, 0.5mL * Saline to total volume of 50 mL (24.5mL of saline) The total amount of solution prepared is 50mL, but typically 30mL is used based on the size of the incision. The total volume administered will be recorded.
Regional Anesthesia
Drug
0.5% ropivicaine - 30mL each sciatic and femoral/saphenous nerve, ultrasound guided

Treatment groups

70 Participants

are divided into 3 treatment groups

Group A: Traditional Pain Control CareNo intervention 0 interventions

Group B: Regional AnesthesiaExperimental treatment 1 intervention

Group C: Long-Acting Local AnesthesiaExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Oral Narcotics / Morphine Milligram Equivalents (MME) given

The medical record (EPIC) will be used to determine the total morphine equivalents given to the patient post-surgery, including recovery unit administration of narcotics in the immediate post-operative period.

Time frame

72 postoperative hours

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Lahey Clinic

Lead sponsor

Source ClinicalTrials.gov

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