Anesthesia Clinical Trial
Official title:
Effect of Dexmedetomidine Added to Lidocaine for Infra- and Supraclavicular Brachial Plexus Block
The purpose of this study is to find out the proper amount of a drug called dexmedetomidine
added to the local anesthetic drug called lidocaine to prolong the time and effect of pain
relief provided for surgery.
Dexmedetomidine (trade name Precedex) is approved by U.S. Food and Drug Administration (FDA)
and indicated for sedation (calming effect). It has both pain relieving and calming effects
when added to lidocaine. In the past, addition of higher amounts of dexmedetomidine to
lidocaine decreased blood pressure and heart rate. The investigators plan to study the
effect of lower amounts of dexmedetomidine to achieve the same level and duration of pain
relief without reduction of blood pressure and heart rate.
Administered intravenously dexmedetomidine exhibits a wide range of effects that include
sedation, analgesia and sympathetic activities, which translate into hemodynamic stability
and anesthetic dose reduction. Recent several experimental works had demonstrated
prolongation of peripheral nerve block with addition of dexmedetomidine. One human study
substantiated this fact when 100µg of dexmedetomidine was added to levobupivacaine during an
axillary approach brachial plexus block. This study also showed that dexmedetomidine used in
this fashion resulted in lower systolic and diastolic pressures and heart rates as compared
to those patients who did not receive the drug. Bradycardia requiring treatment with
atropine occurred in 7 out of 30 patients (23%).
The aim of this randomized prospective study is to determine the optimal dose of
dexmedetomidine added to lidocaine for infra- and supra-clavicular brachial plexus block.
The investigators plan to establish a dose response relationship using 0.3µg/kg and 0.6µg/kg
of dexmedetomidine added to lidocaine, epinephrine and bicarbonate mixture during infra- and
supraclavicular brachial plexus block for upper extremity surgery. The doses to be used in
this study are substantially lower than 100 µg dose used with levobupivacaine previously.
The investigators hypothesis is that dexmedetomidine added to lidocaine at these doses will
shorten the onset and prolong the duration of brachial plexus block without significant
hypotension or bradycardia.
Significant hypotension will be defined as 25% reduction of mean arterial blood pressure
from the baseline or reduction of mean arterial blood pressure below 60 mm Hg.
Significant bradycardia will be defined as 25% reduction of the heart rate from the baseline
or a heart rate less than 50 bpm.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
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