Foot and Ankle Clinic Application for Liposomal Related Anesthetic

NCT02586077 | Completed Phase 4 Results DMC

• 1 other identifier: 12-13-12E
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Ankle Arthrodesis; Hindfoot Arthrodesis; Tibitalocalceal Arthrodesis

Outcome Measures

Primary Outcomes (1)

• Amount of Narcotic Use

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

  Surgery to post operative day 3

Secondary Outcomes (4)

• Visual Analog Scale of Pain (0-10)

  Post anesthesia care unit admission to post operative day 3

• Anti-emetic Use

  After surgery through discharge from hospital, usually 72 hours after surgery (on post operative day 3)

• Patient Satisfaction Questionnaire Regarding Post Surgical Pain Relief

  Measured at hospital discharge (on post operative day 3)

• Number of Patients With Post-operative Complications

  After surgery to the first scheduled clinic visit, usually 14 days after surgery

Study Arms (1)

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.

Drug: Exparel

Interventions

Exparel DRUG

Exparel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \< 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

Sponsors & Collaborators

• OrthoCarolina Research Institute, Inc.: lead
• Pacira Pharmaceuticals, Inc: collaborator

Study Sites (1)

OrthoCarolina, PA

Charlotte, North Carolina, 28203, United States

Location

Results Point of Contact

• Title: Susan Odum
• Organization: OrthoCarolina Research Institute

susan.odum@orthocarolina.com

7049457710

Study Officials

• Susan M Odum, PhD

  OrthoCarolina Research Institute

  STUDY DIRECTOR

• Bruce Cohen, MD

  OrthoCarolina Foot & Ankle Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2015
• First Posted: October 26, 2015
• Study Start: February 1, 2014
• Primary Completion: June 30, 2016
• Study Completion: November 15, 2016
• Last Updated: October 29, 2020
• Results First Posted: October 29, 2020

Record last verified: 2020-10

Locations

US (1)