Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00197353
Status:
COMPLETED
Last Update Posted:
2009-03-06
First Post:
2005-09-13
Brief Title:
Study of Different Concentrations of Epidural Bupivacaine for the Effects on Vasodilatation and Sensory Block
Sponsor:
Hadassah Medical Organization
Organization:
Hadassah Medical Organization
Study Overview
Official Title:
Sympathectomy-Mediated Vasodilatation and Differential Sensory Block After Epidural Bupivacaine a Randomized Concentration Ranging Study
Status:
COMPLETED
Status Verified Date:
2005-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
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 05 bupivacaine group B 10ml of 025 bupivacaine and group C 40ml of 00625 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
We compare three groups group A 10ml of 05 bupivacaine group B 10ml of 025 bupivacaine and group C 40ml of 00625 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None