Phase 4
Completed N=36
Foot and Ankle Clinic Application for Liposomal Related Anesthetic
Ankle Arthrodesis · Hindfoot Arthrodesis · Tibitalocalceal Arthrodesis
Source: ClinicalTrials.gov NCT02586077 ↗
Enrolled (actual)
36
Serious AEs
2.8%
Results posted
Oct 2020
Primary outcomePrimary: Amount of Narcotic Use — 236.68 mg
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
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 | — |
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. Informational only — not medical advice.