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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peripheral Nerve Block Without Exparel | Active Comparator | Lower extremity peripheral nerve block without Exparel: 0.25-0.5% bupivacaine |
|
| Peripheral Nerve Block with Exparel | Experimental | Liposomal bupivicaine administered for peripheral nerve block: mixed with 0.25-0.5% bupivacaine |
|
| Local Infiltration of Exparel | Experimental | Liposomal bupivicaine administered by surgeon intra-operatively in field block, mix with 0.25% bupivacaine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exparel | Drug | Liposomal bupivicaine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Duration of block | 1 year |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anna Ng-Pellegrino | St. Luke's Hospital and Health Network, Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Luke's University Health Network | Bethlehem | Pennsylvania | 18015 | United States |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D064386 | Ankle Fractures |
| D016512 | Ankle Injuries |
| D004194 | Disease |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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patient is blinded to study
| Peripheral Nerve Block | Drug | Peripheral nerve block without Exparel |
|
|
| 1 year |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D007869 | Leg Injuries |
| D000588 |
| Amines |