Official Title

Foot and Ankle Clinic Application for Liposomal Related Anesthetic
  • Phase

    Phase 4
  • Study Type

    Interventional
  • Study Participants

    36
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.
Study Started
Feb 01
2014
Primary Completion
Jun 30
2016
Study Completion
Nov 15
2016
Results Posted
Oct 29
2020
Last Update
Oct 29
2020

Exparel 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.

Criteria

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

Summary

Overall

All Events

Event Type Organ System Event Term Overall

Amount of Narcotic Use

Total morphine milligram equivalence dosing of all narcotic pain medications administered between the surgery and the third post-operative day.

Exparel

236.68
mg (Mean)
Full Range: 45.0 to 570.0

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

Exparel

Day of Surgery

2.36
units on a scale (Mean)
Full Range: 0.0 to 7.0

Post anesthesia care unit admission

0.96
units on a scale (Mean)
Full Range: 0.0 to 10.0

Post anesthesia care unit discharge

0.86
units on a scale (Mean)
Full Range: 0.0 to 6.0

Post-Operative Day 1

5.04
units on a scale (Mean)
Full Range: 1.0 to 10.0

Post-operative Day 2

3.82
units on a scale (Mean)
Full Range: 0.0 to 10.0

Post-operative Day 3

4.29
units on a scale (Mean)
Full Range: 0.0 to 9.0

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).

Overall

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

Overall

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.

Overall

Age, Continuous

55.6
years (Mean)
Full Range: 20.0 to 80.0

Region of Enrollment

Sex: Female, Male

Overall Study

Exparel

Drop/Withdrawal Reasons

Exparel