1000 resultados para block designs


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BACKGROUND AND OBJECTIVES: Nerve blocks using local anesthetics are widely used. High volumes are usually injected, which may predispose patients to associated adverse events. Introduction of ultrasound guidance facilitates the reduction of volume, but the minimal effective volume is unknown. In this study, we estimated the 50% effective dose (ED50) and 95% effective dose (ED95) volume of 1% mepivacaine relative to the cross-sectional area of the nerve for an adequate sensory block. METHODS: To reduce the number of healthy volunteers, we used a volume reduction protocol using the up-and-down procedure according to the Dixon average method. The ulnar nerve was scanned at the proximal forearm, and the cross-sectional area was measured by ultrasound. In the first volunteer, a volume of 0.4 mL/mm of nerve cross-sectional area was injected under ultrasound guidance in close proximity to and around the nerve using a multiple injection technique. The volume in the next volunteer was reduced by 0.04 mL/mm in case of complete blockade and augmented by the same amount in case of incomplete sensory blockade within 20 mins. After 3 up-and-down cycles, ED50 and ED95 were estimated. Volunteers and physicians performing the block were blinded to the volume used. RESULTS: A total 17 of volunteers were investigated. The ED50 volume was 0.08 mL/mm (SD, 0.01 mL/mm), and the ED95 volume was 0.11 mL/mm (SD, 0.03 mL/mm). The mean cross-sectional area of the nerves was 6.2 mm (1.0 mm). CONCLUSIONS: Based on the ultrasound measured cross-sectional area and using ultrasound guidance, a mean volume of 0.7 mL represents the ED95 dose of 1% mepivacaine to block the ulnar nerve at the proximal forearm.

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SUMMARY Split-mouth designs first appeared in dental clinical trials in the late sixties. The main advantage of this study design is its efficiency in terms of sample size as the patients act as their own controls. Cited disadvantages relate to carry-across effects, contamination or spilling of the effects of one intervention to another, period effects if the interventions are delivered at different time periods, difficulty in finding similar comparison sites within patients and the requirement for more complex data analysis. Although some additional thought is required when utilizing a split-mouth design, the efficiency of this design is attractive, particularly in orthodontic clinical studies where carry-across, period effects and dissimilarity between intervention sites does not pose a problem. Selection of the appropriate research design, intervention protocol and statistical method accounting for both the reduced variability and potential clustering effects within patients should be considered for the trial results to be valid.