Foot and Ankle Clinic Application for Liposomal Related Anesthetic

Phase 4

Completed

• Conditions: Hindfoot Arthrodesis; Tibitalocalceal Arthrodesis; Ankle Arthrodesis
• Interventions: Drug: Exparel

• Registration Number: NCT02586077
• Lead Sponsor: OrthoCarolina Research Institute, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02-01
• Study First Submitted: 2015-06-01
• Study First Submitted QC: 2015-10-22
• Study First Posted: 2015-10-26
• Primary Completion: 2016-06-30
• Study Completion: 2016-11-15
• Results First Submitted: 2020-09-16
• Status Verified: 2020-10
• Results First Submitted QC: 2020-10-08
• Last Update Submitted: 2020-10-08
• Results First Posted: 2020-10-29
• Last Update Posted: 2020-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Exparel	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Visual Analog Scale of Pain (0-10)	Post anesthesia care unit admission to post operative day 3	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
Anti-emetic Use	After surgery through discharge from hospital, usually 72 hours after surgery (on post operative day 3)	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).
Patient Satisfaction Questionnaire Regarding Post Surgical Pain Relief	Measured at hospital discharge (on post operative day 3)	Measured at hospital discharge (on post operative day 3). Measured on a scale of 1-5, with 5 being the most satisfaction
Number of Patients With Post-operative Complications	After surgery to the first scheduled clinic visit, usually 14 days after surgery	Any complications occurring between the day of surgery and the first scheduled appointment at our clinic after the surgery.

Trial Locations

Locations (1)

OrthoCarolina, PA; 🇺🇸 Charlotte, North Carolina, United States