Foot and Ankle Clinic Application for Liposomal Related Anesthetic

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 Overview

• Status: Completed
• Conditions: Ankle Arthrodesis; Hindfoot Arthrodesis; Tibitalocalceal Arthrodesis
• Intervention / Treatment: Drug: Exparel

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Charlotte, North Carolina, United States, 28203
      • OrthoCarolina, PA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exparel; 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

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

Collaborators and Investigators

• Sponsor: OrthoCarolina Research Institute, Inc.
• Collaborators: Pacira Pharmaceuticals, Inc
• Investigators: Study Director: Susan M Odum, PhD, OrthoCarolina Research Institute; Principal Investigator: Bruce Cohen, MD, OrthoCarolina Foot & Ankle Institute

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): June 30, 2016
• Study Completion (Actual): November 15, 2016

Study Registration Dates

• First Submitted: June 1, 2015
• First Submitted That Met QC Criteria: October 22, 2015
• First Posted (Estimate): October 26, 2015

Study Record Updates

• Last Update Posted (Actual): October 29, 2020
• Last Update Submitted That Met QC Criteria: October 8, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 12-13-12E