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Foot and Ankle Clinic Application for Liposomal Related Anesthetic

NCT ID: NCT02586077

Last Updated: 2020-10-29

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-01

Study Completion Date

2016-11-15

Brief Summary

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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

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Conditions

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Ankle Arthrodesis Hindfoot Arthrodesis Tibitalocalceal Arthrodesis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Exparel

Intervention Type DRUG

Interventions

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Exparel

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pacira Pharmaceuticals, Inc

INDUSTRY

Sponsor Role collaborator

OrthoCarolina Research Institute, Inc.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Susan M Odum, PhD

Role: STUDY_DIRECTOR

OrthoCarolina Research Institute

Bruce Cohen, MD

Role: PRINCIPAL_INVESTIGATOR

OrthoCarolina Foot & Ankle Institute

Locations

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OrthoCarolina, PA

Charlotte, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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12-13-12E

Identifier Type: -

Identifier Source: org_study_id