Foot and Ankle Clinic Application for Liposomal Related Anesthetic

OrthoCarolina Research Institute, Inc.

Status and phase: Completed; Phase 4

Conditions: Hindfoot Arthrodesis; Tibitalocalceal Arthrodesis; Ankle Arthrodesis

Treatments: Drug: Exparel

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02586077

12-13-12E

Details and patient eligibility

About

The purpose of this study is to review the use of surgeon applied liposomal release anesthetic (Exparel) for post operative analgesia.

Hypothesis: Surgeon applied use of liposomal related anesthetic provides excellent post operative analgesia. Immediated and 72 hour narcotic use will be significantly impacted by the use of this modality.

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Any patient scheduled for ankle arthrodesis, a tibiotalocalcaneal arthrodesis, hindfoot arthrodesis including subtalar, double, triple, or isolated talonavicular arthrodesis
• Patients over the age of 18
• The subject is psychosocially, mentally, and physically able to understand and comply with the requirements of the study

Exclusion criteria

• < 18 years of age
• Patients with a history of infection
• Patients diagnosed with neuropathy or any form of numbness or loss of feeling in the arms or legs due to damaged nerves
• Patients having surgery on both feet at the same time
• Patients having any other different type of foot and ankle surgery

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 1 patient group

Exparel

Experimental group

Description:

Patients will receive a single shot popliteal block (standard of care) and then undergo their standardized procedure. Patients will then receive 20cc Exparel and 10cc of normal saline at the conclusion of the case.

Treatment:

Drug: Exparel