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Sponsored by: |
Hadassah Medical Organization |
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Information provided by: | Hadassah Medical Organization |
ClinicalTrials.gov Identifier: | NCT00197353 |
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.
Condition | Intervention | Phase |
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Intraoperative Complications |
Drug: Epidural bupivacaine (dose/concentration/volume ranging) |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Pharmacodynamics Study |
Official Title: | Sympathectomy-Mediated Vasodilatation and Differential Sensory Block After Epidural Bupivacaine: a Randomized Concentration Ranging Study |
Estimated Enrollment: | 60 |
Study Start Date: | March 1999 |
Estimated Study Completion Date: | September 1999 |
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.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Israel | |
Hadassah Hebrew University Medical Center | |
Jerusalem, Israel, 91120 |
Principal Investigator: | Yehuda Ginosar, BSc MBBS | Hadassah-Hebrew University Medical Center |
Study ID Numbers: | PPG1-ginosar-HMO-CTIL |
Study First Received: | September 13, 2005 |
Last Updated: | March 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00197353 History of Changes |
Health Authority: | Israel: Ministry of Health |
Anesthesia, Epidural Pharmacology Dose-Response Relationship, Drug Sympathectomy Photoplethysmography |
Central Nervous System Depressants Anesthetics Bupivacaine |
Peripheral Nervous System Agents Intraoperative Complications Anesthetics, Local |
Pathologic Processes Sensory System Agents Therapeutic Uses Physiological Effects of Drugs Central Nervous System Depressants Anesthetics |
Bupivacaine Peripheral Nervous System Agents Intraoperative Complications Central Nervous System Agents Pharmacologic Actions Anesthetics, Local |