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Withdrawn from the IRB
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By utilizing regional anesthesia blocks at the surgery tissue donor sites, it can potentially reduce post-operative pain while also reducing the use of opioids. It can aim to measure the reduction in opioid use, reduction in pain scores, patient satisfaction, and because there is not a current protocol established for regional anesthesia use for free flap reconstruction, and we aim to standardize the procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fibular free flap-Block performed | Active Comparator | For subjects in the experimental/regional anesthesia group for anterolateral thigh or radial forearm free flap, during the procedure a catheter will be placed into the donor site (leg or arm), wound bed |
|
| Anterolateral thigh free flap-Block performed | Active Comparator | Description: For subjects in the experimental/regional anesthesia group for anterolateral thigh or radial forearm free flap, during the procedure a catheter will be placed into the donor site (leg or arm), wound bed |
|
| Radial forearm free flap-Block performed | Active Comparator | Description: For subjects in the experimental/regional anesthesia group for anterolateral thigh or radial forearm free flap, during the procedure a catheter will be placed into the donor site (leg or arm), wound bed |
|
| Fibular free flap -Control | No Intervention | No additional procedures beyond the normal standard of care will be performed | |
| Anterolateral thigh free flap-Control | No Intervention | No additional procedures beyond the normal standard of care will be performed |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Regional Anesthesia | Drug | Block performed is an indwelling wound bed or popliteal catheter placed intraoperatively |
|
| Measure | Description | Time Frame |
|---|---|---|
| Opioid consumption | Subjects' morphine equivalent dose. Postoperative period commences at extubation. | 72 hours (3 days) post-operatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rui Fernandes, MD, DMD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Jacksonville | Florida | 32209 | United States |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D000765 | Anesthesia, Conduction |
| ID | Term |
|---|---|
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
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| Radial forearm free flap-Control | No Intervention | No additional procedures beyond the normal standard of care will be performed |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |