Ankle Fractures, Ankle Injuries and Disorders, Pain, Acute Postoperative, Pain, Postoperative
Conditions
Keywords
liposomal bupivacaine, ankle surgery, postoperative pain, regional nerve block
Brief summary
Liposomal Bupivacaine (Exparel) has been recently studied as the active agent utilized in various nerve block. Due to its liposomal form allowing for extended delivery, Exparel has been used in various peri-operative nerve blocks among multiple orthopaedic specialties in hopes of achieving improved pain control and decreased opioid use. This study compares the efficacy and effect on opioid use of peripheral nerve blocks and local infiltration with and without Exparel in patients undergoing foot and ankle surgery.
Detailed description
three study groups: A - surgeon infiltrates with exparel on site of surgery; B - anesthesia provides a regional nerve block (popliteal/adductor blocks) with plain local anesthetic (bupivacaine); C - anesthesia provides a regional nerve block (popliteal/adductor) with Exparel/bupivacaine mix. Follow up occurs on postop day 4 via phone call to patient. Measured outcomes include opioid consumption in post anesthesia care unit phase (oral morphine equivalents), block duration, number of opioid pills used by postop day 4, oral morphine equivalent consumption by postop day 4.
Interventions
DRUGExparel
Liposomal bupivicaine
DRUGPeripheral Nerve Block
Peripheral nerve block without Exparel
Sponsors
St. Luke's Hospital, Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
patient is blinded to study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients undergoing elective orthopaedic foot and ankle surgery at a single institution * English speaking * Able to provide consent to surgery and study participation
Exclusion criteria
* Non-elective or emergent foot and ankle surgery * Non-english speaking * Does not possess medical decision making capacity
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Duration of block | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| number of opioid pills used by postoperative day # 4 | 1 year |
| PROMIS Scores | 1 year |
| oral morphine equivalent use by postoperative day 4 | 1 year |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAnna Ng-Pellegrino
St. Luke's Hospital and Health Network, Pennsylvania
Outcome results
None listed