Study of Different Concentrations of Epidural Bupivacaine for the Effects on Vasodilatation and Sensory Block
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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 |
---|---|---|
Intraoperative Complications |
Drug: Epidural bupivacaine (dose/concentration/volume ranging) |
Phase 3 |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Prevention |
Official Title: | Sympathectomy-Mediated Vasodilatation and Differential Sensory Block After Epidural Bupivacaine: a Randomized Concentration Ranging Study |
- Index of sympathectomy: photoplethysmography derived amplitude-baseline ratio from foot and hand; data measured at time 0, 5, 10 and 20 min following epidural; data expressed as % change from baseline and as area under time effect curve.
- 1. Other indices of sympathectomy:
- a. Photoplethysmography derived baseline change (ln (Blepi/Blo));
- b. Photoplethysmography derived time lag between pulse reaching hand and foot;
- c. Blood pressure (mean, systolic, diastolic);
- d. Skin temperature changes (finger and toe temperature change from baseline, toe-thigh and finger-arm temperature gradients).
- 2. Sensory level (pinprick, touch, cold)
- 3. Motor block (Bromage scale)
- All assessments made at 0, 5, 10 and 20 minutes after epidural drug administration.
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:
- Patients scheduled for extracorporeal shock wave lithotripsy (ESWL) under epidural anesthesia between March to September 1999
Exclusion Criteria:
- graded as ASA 3 or higher, below 18 or above 70 years of age, if they had peripheral vascular disease, baseline neurological deficit, or had any other contraindication for regional anesthesia.
Israel | |
Hadassah Hebrew University Medical Center | |
Jerusalem, Israel, 91120 |
Principal Investigator: | Yehuda Ginosar, BSc MBBS | Hadassah Medical Organization |
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: | NCT00197353 History of Changes |
Other Study ID Numbers: | PPG1-ginosar-HMO-CTIL |
Study First Received: | September 13, 2005 |
Last Updated: | March 5, 2009 |
Health Authority: | Israel: Ministry of Health |
Keywords provided by Hadassah Medical Organization:
Anesthesia, Epidural Pharmacology Dose-Response Relationship, Drug Sympathectomy Photoplethysmography |
Additional relevant MeSH terms:
Intraoperative Complications Pathologic Processes Bupivacaine Anesthetics, Local Anesthetics Central Nervous System Depressants |
Physiological Effects of Drugs Pharmacologic Actions Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on October 16, 2012