Foot and Ankle Clinic Application for Liposomal Related Anesthetic

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Foot and Ankle Clinic Application for Liposomal Related Anesthetic

Conditions
-----------------
Ankle Arthrodesis, Hindfoot Arthrodesis, Tibitalocalceal Arthrodesis

Intervention / Treatment
-----------------
* Drug: Exparel


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exparel<br>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. | Drug: Exparel<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of Narcotic Use | Total morphine milligram equivalence dosing of all narcotic pain medications administered between the surgery and the third post-operative day. | Surgery to post operative day 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale of Pain (0-10) | Visual Analog Scale (VAS) of pain (0-10); with 10 indicating the greatest amount of pain. Post anesthesia care unit admission, post anesthesia care unit discharge, day of surgery, post operative day 1, post operative day 2, post operative day 3 | Post anesthesia care unit admission to post operative day 3 | 
| Anti-emetic Use | Anti-emetic use (as a binary yes/no) between the admission in the post anesthesia care unit through hospital discharge (i.e. if a patient took an anti-emetic at any point duration the time frame the patient was a yes; if the patient did not take an anti-emetic during the time frame the patient was a no). | After surgery through discharge from hospital, usually 72 hours after surgery (on post operative day 3) | 
| Patient Satisfaction Questionnaire Regarding Post Surgical Pain Relief | Measured at hospital discharge (on post operative day 3). Measured on a scale of 1-5, with 5 being the most satisfaction | Measured at hospital discharge (on post operative day 3) | 
| Number of Patients With Post-operative Complications | Any complications occurring between the day of surgery and the first scheduled appointment at our clinic after the surgery. | After surgery to the first scheduled clinic visit, usually 14 days after surgery |