Ankle Arthrodesis, Hindfoot Arthrodesis, Tibitalocalceal Arthrodesis
Conditions
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.
Interventions
DRUGExparel
Sponsors
Pacira Pharmaceuticals, Inc
OrthoCarolina Research Institute, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Amount of Narcotic Use | 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
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale of Pain (0-10) | 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 |
| Anti-emetic Use | 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). |
| Patient Satisfaction Questionnaire Regarding Post Surgical Pain Relief | 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 |
| Number of Patients With Post-operative Complications | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Exparel 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. | 28 |
| Total | 28 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 3 |
| Overall Study | Physician Decision | 4 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Exparel | — |
|---|---|---|
| Age, Continuous | 55.6 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 28 participants | — |
| Sex: Female, Male Female | 18 Participants | — |
| Sex: Female, Male Male | 10 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 36 |
| other Total, other adverse events | 1 / 36 |
| serious Total, serious adverse events | 1 / 36 |
Outcome results
Primary
Amount of Narcotic Use
Total morphine milligram equivalence dosing of all narcotic pain medications administered between the surgery and the third post-operative day.
Time frame: Surgery to post operative day 3
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Exparel | Amount of Narcotic Use | 236.68 mg |
Secondary
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).
Time frame: After surgery through discharge from hospital, usually 72 hours after surgery (on post operative day 3)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Exparel | Anti-emetic Use | No | 19 Participants |
| Exparel | Anti-emetic Use | Yes | 9 Participants |
Secondary
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.
Time frame: After surgery to the first scheduled clinic visit, usually 14 days after surgery
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Exparel | Number of Patients With Post-operative Complications | No | 27 Participants |
| Exparel | Number of Patients With Post-operative Complications | Yes | 1 Participants |
Secondary
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
Time frame: Measured at hospital discharge (on post operative day 3)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Exparel | Patient Satisfaction Questionnaire Regarding Post Surgical Pain Relief | 1 | 3 Participants |
| Exparel | Patient Satisfaction Questionnaire Regarding Post Surgical Pain Relief | 2 | 3 Participants |
| Exparel | Patient Satisfaction Questionnaire Regarding Post Surgical Pain Relief | 3 | 4 Participants |
| Exparel | Patient Satisfaction Questionnaire Regarding Post Surgical Pain Relief | 4 | 6 Participants |
| Exparel | Patient Satisfaction Questionnaire Regarding Post Surgical Pain Relief | 5 | 12 Participants |
Secondary
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
Time frame: Post anesthesia care unit admission to post operative day 3
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Exparel | Visual Analog Scale of Pain (0-10) | Post anesthesia care unit admission | 0.96 units on a scale |
| Exparel | Visual Analog Scale of Pain (0-10) | Post anesthesia care unit discharge | 0.86 units on a scale |
| Exparel | Visual Analog Scale of Pain (0-10) | Day of Surgery | 2.36 units on a scale |
| Exparel | Visual Analog Scale of Pain (0-10) | Post-Operative Day 1 | 5.04 units on a scale |
| Exparel | Visual Analog Scale of Pain (0-10) | Post-operative Day 2 | 3.82 units on a scale |
| Exparel | Visual Analog Scale of Pain (0-10) | Post-operative Day 3 | 4.29 units on a scale |