Foot and Ankle Clinic Application for Liposomal Related Anesthetic

Ankle Arthrodesis Clinical Trial

Official title:

Foot and Ankle Clinic Application for Liposomal Related Anesthetic

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02586077
• Other study ID #: 12-13-12E
• Status: Completed
• Phase: Phase 4
• Start date: February 1, 2014
• Est. completion date: November 15, 2016

Study information

• Verified date: October 2020
• Source: OrthoCarolina Research Institute, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: November 15, 2016
• Est. primary completion date: June 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ankle Arthrodesis
• Hindfoot Arthrodesis
• Tibitalocalceal Arthrodesis

Intervention

Drug:
• Exparel

Locations

Country	Name	City	State
United States	OrthoCarolina, PA	Charlotte	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
OrthoCarolina Research Institute, Inc.	Pacira Pharmaceuticals, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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)
Secondary	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)
Secondary	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