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Vancomycin Tissue Concentrations by Bier Block or Intravenous Administration

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04673877
Enrollment
20
Registered
2020-12-17
Start date
2021-08-26
Completion date
2022-08-17
Last updated
2022-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief summary

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).

Interventions

DRUGSystemic IV Vancomycin

1 g of vancomycin will be delivered intravenously over a period of one hour prior to tourniquet inflation.

PROCEDUREBier Block

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.

DRUGVancomycin

500 mg diluted in 50 cc normal saline of injection into superficial vein in the hand, wrist or forearm

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Tissue concentrations of vancomycinApproximately 45-60 minutes after skin incisionTissue concentrations of vancomycin in the hand and wrist following Bier Block administration versus systemic IV administration

Secondary

MeasureTime frameDescription
Adverse Events1 yearNumber of adverse events reported for Bier Block administered vancomycin

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026