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Foot and Ankle Clinic Application for Liposomal Related Anesthetic

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02586077
Recruitment Status : Completed
First Posted : October 26, 2015
Last Update Posted : February 9, 2017
Pacira Pharmaceuticals, Inc
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Ankle Arthrodesis Hindfoot Arthrodesis Tibitalocalceal Arthrodesis Drug: Exparel Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Foot and Ankle Clinic Application for Liposomal Related Anesthetic
Study Start Date : February 1, 2014
Actual Primary Completion Date : June 30, 2016
Actual Study Completion Date : November 15, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health

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

Primary Outcome Measures :
  1. Amount of Narcotic Use [ Time Frame: Surgery to post operative day 3 ]

Secondary Outcome Measures :
  1. Visual Analog Scale of pain (0-10) [ Time Frame: pre-operative to post operative day 3 ]
    pre-operatively, 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

  2. Anti-emetic use [ Time Frame: After surgery through discharge from hospital, usually 72 hours after surgery (on post operative day 3) ]
    Amount of anti-emetic use between the admission in the post anesthesia care unit through hospital discharge

  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 ]
  4. Complications [ Time Frame: 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02586077

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United States, North Carolina
OrthoCarolina, PA
Charlotte, North Carolina, United States, 28203
Sponsors and Collaborators
OrthoCarolina Research Institute, Inc.
Pacira Pharmaceuticals, Inc
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Study Director: Susan M Odum, PhD OrthoCarolina Research Institute
Principal Investigator: Bruce Cohen, MD OrthoCarolina Foot & Ankle Institute

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Responsible Party: OrthoCarolina Research Institute, Inc. Identifier: NCT02586077     History of Changes
Other Study ID Numbers: 12-13-12E
First Posted: October 26, 2015    Key Record Dates
Last Update Posted: February 9, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
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Central Nervous System Depressants
Physiological Effects of Drugs