Phase 4
N=36
Foot and Ankle Clinic Application for Liposomal Related Anesthetic
Ankle Arthrodesis · Hindfoot Arthrodesis · Tibitalocalceal Arthrodesis
Bottom Line
View on ClinicalTrials.gov: NCT02586077 ↗Enrolled (actual)
36
Serious AEs
2.8%
Results posted
Oct 2020
Primary outcome: Primary: Amount of Narcotic Use — 236.68 mg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Exparel (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- OrthoCarolina Research Institute, Inc.
- Primary completion
- Jun 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Amount of Narcotic Use |
236.68 | — |
| SECONDARY Visual Analog Scale of Pain (0-10) |
0.96; 0.86; 2.36; 5.04; 3.82; 4.29 | — |
| SECONDARY Anti-emetic Use |
19; 9 | — |
| SECONDARY Patient Satisfaction Questionnaire Regarding Post Surgical Pain Relief |
3; 3; 4; 6; 12 | — |
| SECONDARY Number of Patients With Post-operative Complications |
27; 1 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02586077). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.