Overview

This trial is active, not recruiting.

Conditions ankle arthrodesis, hindfoot arthrodesis, tibitalocalceal arthrodesis
Treatment exparel
Phase phase 4
Sponsor OrthoCarolina Research Institute, Inc.
Collaborator Pacira Pharmaceuticals, Inc
Start date February 2014
End date June 2016
Trial size 36 participants
Trial identifier NCT02586077, 12-13-12E

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.
exparel

Primary Outcomes

Measure
Amount of Narcotic Use
time frame: Surgery to post operative day 3

Secondary Outcomes

Measure
Visual Analog Scale of pain (0-10)
time frame: pre-operative to post operative day 3
Anti-emetic use
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
time frame: Measured at hospital discharge (on post operative day 3) and at first scheduled clinic post-operative visit, usually at 14 days after surgery
Complications
time frame: After surgery to the first scheduled clinic visit, usually 14 days after surgery

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Foot and Ankle Clinic Application for Liposomal Related Anesthetic
Principal investigator Bruce Cohen, MD
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by OrthoCarolina Research Institute, Inc..