Foot and Ankle Clinic Application for Liposomal Related Anesthetic
This trial is active, not recruiting.
|Conditions||ankle arthrodesis, hindfoot arthrodesis, tibitalocalceal arthrodesis|
|Sponsor||OrthoCarolina Research Institute, Inc.|
|Collaborator||Pacira Pharmaceuticals, Inc|
|Start date||February 2014|
|End date||June 2016|
|Trial size||36 participants|
|Trial identifier||NCT02586077, 12-13-12E|
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.
|Endpoint classification||efficacy study|
|Intervention model||single group assignment|
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.
Amount of Narcotic Use
time frame: Surgery to post operative day 3
Visual Analog Scale of pain (0-10)
time frame: pre-operative to post operative day 3
time frame: After surgery through discharge from hospital, usually 72 hours after surgery (on post operative day 3)
Patient Satisfaction Questionnaire regarding post surgical pain relief
time frame: Measured at hospital discharge (on post operative day 3) and at first scheduled clinic post-operative visit, usually at 14 days after surgery
time frame: After surgery to the first scheduled clinic visit, usually 14 days after surgery
Male or female participants at least 18 years old.
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
|Official title||Foot and Ankle Clinic Application for Liposomal Related Anesthetic|
|Principal investigator||Bruce Cohen, MD|
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