Vancomycin Tissue Concentrations by Bier Block or Intravenous Administration

Study Overview
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Brief Summary
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The purpose of this study is to determine whether or not giving a lower dose of antibiotics (Vancomycin) in the area where it is needed (upper extremity) is more effective at preventing infection than the current standard dose which is given intravenously (IV).

Official Title
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Tissue Concentrations of Vancomycin Achieved With Bier Block Administration Versus Intravenous Prophylaxis in Upper Extremity Surgery: A Randomized Controlled Trial

Conditions
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Infection, Hand Injury Wrist, Hand Injuries, Hand Injuries and Disorders, Hand Arthritis

Intervention / Treatment
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* Drug: Systemic IV Vancomycin
* Procedure: Bier Block
* Drug: Vancomycin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing upper extremity reconstruction by a single surgeon. Surgical cases will include: Trapeziectomy/suspensionplasty. PIPJ/MPJ arthroplasty. Proximal row carpectomy. Distal ulnar resection. Distal radius fracture fixation. Exclusion Criteria: Inability to adequately cannulate a superficial vein in the upper extremity within 5 minutes of tourniquet inflation. Evidence of subcutaneous extravasation in Bier block group. History of renal dysfunction. Vancomycin allergy. ASA>/= 3. History of lung cancer. Known HIV infection. History of organ transplantation.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bier Block Group<br>Subjects will receive antibiotic Vancomycin from a Bier Block (injected into an arm vein with a tourniquet up to keep antibiotics in the arm). Samples will be collected from bone and tissue that is normally removed during surgery. | Procedure: Bier Block<br>* After exsanguination of the limb and elevation of the tourniquet in the prepped and draped patient, Vancomycin will be injected into a superficial vein in the hand, wrist or forearm.<br>Drug: Vancomycin<br>* 500 mg diluted in 50 cc normal saline of injection into superficial vein in the hand, wrist or forearm<br>|
| Active Comparator: Systemic Intravenous IV Group<br>Subjects will receive antibiotic Vancomycin through intravenous administration. Samples will be collected from bone and tissue that is normally removed during during surgery. | Drug: Systemic IV Vancomycin<br>* 1 g of vancomycin will be delivered intravenously over a period of one hour prior to tourniquet inflation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tissue concentrations of vancomycin | Tissue concentrations of vancomycin in the hand and wrist following Bier Block administration versus systemic IV administration | Approximately 45-60 minutes after skin incision | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Number of adverse events reported for Bier Block administered vancomycin | 1 year |