Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE4
INTERVENTIONAL
2020-03-31
2021-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Fibular free flap-Block performed
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
Regional Anesthesia
Block performed is an indwelling wound bed or popliteal catheter placed intraoperatively
Anterolateral thigh free flap-Block performed
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
Regional Anesthesia
Block performed is an indwelling wound bed or popliteal catheter placed intraoperatively
Radial forearm free flap-Block performed
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
Regional Anesthesia
Block performed is an indwelling wound bed or popliteal catheter placed intraoperatively
Fibular free flap -Control
No additional procedures beyond the normal standard of care will be performed
No interventions assigned to this group
Anterolateral thigh free flap-Control
No additional procedures beyond the normal standard of care will be performed
No interventions assigned to this group
Radial forearm free flap-Control
No additional procedures beyond the normal standard of care will be performed
No interventions assigned to this group
Interventions
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Regional Anesthesia
Block performed is an indwelling wound bed or popliteal catheter placed intraoperatively
Eligibility Criteria
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Inclusion Criteria
* Subjects undergoing primary reconstruction for both benign and malignant etiology
Exclusion Criteria
* Subjects with true allergies to the study drugs, reporting anaphylaxis in the past
* Subjects undergoing reconstruction with more than 1 free flap
* Subjects undergoing secondary reconstructions
* Subjects undergoing surgery for osteonecrosis
* History of enrollment in a pain management program
* Any subject currently enrolled in pain management, or currently taking long acting opioids such as methadone or oxycontin
18 Years
90 Years
ALL
Yes
Sponsors
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University of Florida
OTHER
Responsible Party
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Principal Investigators
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Rui Fernandes, MD, DMD
Role: PRINCIPAL_INVESTIGATOR
University of Florida
Locations
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University of Florida
Jacksonville, Florida, United States
Countries
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Other Identifiers
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IRB201903261
Identifier Type: -
Identifier Source: org_study_id
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