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Completed

NCT Number: NCT02586077

Foot and Ankle Clinic Application for Liposomal Related Anesthetic

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.

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Key information

Conditions

Ankle Arthrodesis Hindfoot Arthrodesis Tibitalocalceal Arthrodesis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

OrthoCarolina, PA

Charlotte, North Carolina, 28203, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exparel

Drug

Primary outcomes

  1. Amount of Narcotic Use

    Time frame: 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 outcomes

  1. Visual Analog Scale of Pain (0-10)

    Time frame: 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

  2. Anti-emetic Use

    Time frame: 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).

  3. Patient Satisfaction Questionnaire Regarding Post Surgical Pain Relief

    Time frame: 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

  4. Number of Patients With Post-operative 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.

Sponsors and collaborators

Lead sponsor

OrthoCarolina Research Institute, Inc.

Other

Collaborators

  • Pacira Pharmaceuticals, Inc

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Oct 26, 2015
Registry last updated
Oct 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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