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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epidural bupivacaine (dose/concentration/volume ranging) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 1. Other indices of sympathectomy: | ||
| a. Photoplethysmography derived baseline change (ln (Blepi/Blo)); | ||
| b. Photoplethysmography derived time lag between pulse reaching hand and foot; |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yehuda Ginosar, BSc MBBS | Hadassah Medical Organization | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hadassah Hebrew University Medical Center | Jerusalem | 91120 | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11411248 | Result | Babchenko A, Davidson E, Ginosar Y, Kurz V, Faib I, Adler D, Nitzan M. Photoplethysmographic measurement of changes in total and pulsatile tissue blood volume, following sympathetic blockade. Physiol Meas. 2001 May;22(2):389-96. doi: 10.1088/0967-3334/22/2/310. | |
| 19397502 | Derived | Ginosar Y, Weiniger CF, Meroz Y, Kurz V, Bdolah-Abram T, Babchenko A, Nitzan M, Davidson EM. Pulse oximeter perfusion index as an early indicator of sympathectomy after epidural anesthesia. Acta Anaesthesiol Scand. 2009 Sep;53(8):1018-26. doi: 10.1111/j.1399-6576.2009.01968.x. Epub 2009 Apr 24. |
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| ID | Term |
|---|---|
| D007431 | Intraoperative Complications |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 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. |
| 19247742 | Derived | Ginosar Y, Weiniger CF, Kurz V, Babchenko A, Nitzan M, Davidson E. Sympathectomy-mediated vasodilatation: a randomized concentration ranging study of epidural bupivacaine. Can J Anaesth. 2009 Mar;56(3):213-21. doi: 10.1007/s12630-008-9036-z. Epub 2009 Jan 28. |