Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
100 participants
INTERVENTIONAL
2020-01-13
2022-03-01
Brief Summary
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Detailed Description
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Regional anesthesia provides a non opioid based, pain control strategy. First, regional anesthesia decreases systemic adverse events including respiratory failure in abdominal surgery, decreases length of stay and improves rehabilitation in common orthopedic procedures such as total knee arthroplasty and shoulder arthroplasty. Second, the physiologic benefits of regional anesthesia are compelling including augmented micro and macrocirculation, maintenance of body temperature and decreased systemic stress response through chemical sympathectomy. Finally, regional anesthesia has been established as safe in the microvascular and anesthesia literature for pediatric, and adult patients.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Experimental Group
US-guided ipsilateral sciatic nerve block for fibula free flap patients utilizing ropivacaine 0.2% at 2-8 cc/hr for fibula free flap patients; US-guided infraclavicular brachial plexus nerve block for forearm free lap patients utilizing ropivacaine 0.2% at 2-8cc/hr for forearm free flap patients.
ropivicaine 0.2%
2-8 cc/hr of 0.2% ropivicaine given as a regional block via US-guided ipsilateral sciatic nerve block for fibula free flap patients or US-guided infraclavicular brachial plexus nerve block for forearm free flap patients.
Control Group
No regional anesthetic of any kind during the surgical procedure.
No interventions assigned to this group
Interventions
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ropivicaine 0.2%
2-8 cc/hr of 0.2% ropivicaine given as a regional block via US-guided ipsilateral sciatic nerve block for fibula free flap patients or US-guided infraclavicular brachial plexus nerve block for forearm free flap patients.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Able to consent for themselves
* Undergoing a head and neck surgery at UAB with reconstruction using either a forearm free flap or a fibula free flap
Exclusion Criteria
* Unable to consent for themselves
* Non-English speakers
* Non-resectable tumor
* Have a known opioid tolerance, or are on a home opioid regimen for a chronic condition. (Short-term opioid use for diagnostic procedures (i.e. biopsy) or new cancer diagnosis will be allowed).
* Patients with known hepatic failure, renal failure, or sulfa allergy, as determined by standard of care labs drawn within 30 days of enrollment
18 Years
ALL
No
Sponsors
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University of Alabama at Birmingham
OTHER
Responsible Party
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Anthony Morlandt
Principal Investigator
Principal Investigators
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Anthony Morlandt, MD
Role: PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Countries
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References
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Le JM, Gigliotti J, Sayre KS, Morlandt AB, Ying YP. Supplemental Regional Block Anesthesia Reduces Opioid Utilization Following Free Flap Reconstruction of the Oral Cavity: A Prospective, Randomized Clinical Trial. J Oral Maxillofac Surg. 2023 Feb;81(2):140-149. doi: 10.1016/j.joms.2022.10.015. Epub 2022 Nov 1.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Related Links
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Journal of Oral and Maxillofacial Surgery, Published November 1, 2022
Other Identifiers
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IRB-300003574
Identifier Type: -
Identifier Source: org_study_id