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

This study has been completed.
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00197353
First received: September 13, 2005
Last updated: March 5, 2009
Last verified: May 2005
  Purpose

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

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

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.

Estimated Enrollment: 60
Study Start Date: March 1999
Estimated Study Completion Date: September 1999
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00197353

Locations
Israel
Hadassah Hebrew University Medical Center
Jerusalem, Israel, 91120
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Yehuda Ginosar, BSc MBBS Hadassah Medical Organization
  More Information

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 July 23, 2014