Foot and Ankle Clinic Application for Liposomal Related Anesthetic

OrthoCarolina Research Institute, Inc.36 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Ankle Arthrodesis Hindfoot Arthrodesis Tibitalocalceal Arthrodesis

Interventions

ExparelDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

OrthoCarolina, PA

Charlotte, North Carolina, United States

Outcomes

Primary Outcomes

Amount of Narcotic Use

Total morphine milligram equivalence dosing of all narcotic pain medications administered between the surgery and the third post-operative day.

Time frame: Surgery to post operative day 3

Secondary Outcomes

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

Time frame: 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).

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

Measured at hospital discharge (on post operative day 3). Measured on a scale of 1-5, with 5 being the most satisfaction

Time frame: 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.

Time frame: After surgery to the first scheduled clinic visit, usually 14 days after surgery

Data from ClinicalTrials.gov

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