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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.
Age
18 - 70 years
Sex
ALL
Healthy Volunteers
No
Hadassah Hebrew University Medical Center
Jerusalem, Israel
Start Date
March 1, 1999
Completion Date
September 1, 1999
Last Updated
March 6, 2009
60
Estimated participants
Epidural bupivacaine (dose/concentration/volume ranging)
DRUG
Lead Sponsor
Hadassah Medical Organization
NCT06450834
NCT00861367
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