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Study of Different Concentrations of Epidural Bupivacaine for the Effects on Vasodilatation and Sensory Block

Primary Purpose

Intraoperative Complications

Status
Completed
Phase
Phase 3
Locations
Israel
Study Type
Interventional
Intervention
Epidural bupivacaine (dose/concentration/volume ranging)
Sponsored by
Hadassah Medical Organization
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Intraoperative Complications focused on measuring Anesthesia, Epidural, Pharmacology, Dose-Response Relationship, Drug, Sympathectomy, Photoplethysmography

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hadassah Hebrew University Medical Center

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
September 13, 2005
Last Updated
March 5, 2009
Sponsor
Hadassah Medical Organization
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1. Study Identification

Unique Protocol Identification Number
NCT00197353
Brief Title
Study of Different Concentrations of Epidural Bupivacaine for the Effects on Vasodilatation and Sensory Block
Official Title
Sympathectomy-Mediated Vasodilatation and Differential Sensory Block After Epidural Bupivacaine: a Randomized Concentration Ranging Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2005
Overall Recruitment Status
Completed
Study Start Date
March 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 1999 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Hadassah Medical Organization

4. Oversight

5. Study Description

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.
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intraoperative Complications
Keywords
Anesthesia, Epidural, Pharmacology, Dose-Response Relationship, Drug, Sympathectomy, Photoplethysmography

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
60 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Epidural bupivacaine (dose/concentration/volume ranging)
Primary Outcome Measure Information:
Title
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.
Secondary Outcome Measure Information:
Title
1. Other indices of sympathectomy:
Title
a. Photoplethysmography derived baseline change (ln (Blepi/Blo));
Title
b. Photoplethysmography derived time lag between pulse reaching hand and foot;
Title
c. Blood pressure (mean, systolic, diastolic);
Title
d. Skin temperature changes (finger and toe temperature change from baseline, toe-thigh and finger-arm temperature gradients).
Title
2. Sensory level (pinprick, touch, cold)
Title
3. Motor block (Bromage scale)
Title
All assessments made at 0, 5, 10 and 20 minutes after epidural drug administration.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yehuda Ginosar, BSc MBBS
Organizational Affiliation
Hadassah Medical Organization
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hadassah Hebrew University Medical Center
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel

12. IPD Sharing Statement

Citations:
PubMed Identifier
11411248
Citation
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.
Results Reference
result
PubMed Identifier
19397502
Citation
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.
Results Reference
derived
PubMed Identifier
19247742
Citation
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. Erratum In: Can J Anaesth. 2010 Jun;57(6):626.
Results Reference
derived

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Study of Different Concentrations of Epidural Bupivacaine for the Effects on Vasodilatation and Sensory Block

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