Intraoperative Complications Clinical Trial
Official title:
Sympathectomy-Mediated Vasodilatation and Differential Sensory Block After Epidural Bupivacaine: a Randomized Concentration Ranging Study
This study aims to compare human subjects receiving epidural bupivacaine local anesthetic at
different doses and concentrations and to assess the effect on vasodilatation
(sympathectomy), sensory and motor block.
The hypothesis is that the drug concentration is more important than drug dose in the
determination of the extent and intensity of differential sympathetic, sensory and motor
block following epidural local anesthetic.
There is controversy regarding the factors that determine the extent and intensity of
epidural drug action. Most studies have focused on the inter-related triad of dose,
concentration and volume.
We compare three groups: group A: 10ml of 0.5% bupivacaine; group B: 10ml of 0.25%
bupivacaine and group C: 40ml of 0.0625% bupivacaine. When comparing these groups, groups A
& B have the same volume of epidural drug, and groups B & C have the same total dose.
In particular this study compares different methods of assessing the sympathetic block
(causing vasodilatation). These methods include skin temperature changes, hemodynamic
changes and photoplethysmography.
;
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
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