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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00197353
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : March 6, 2009
Information provided by:
Hadassah Medical Organization

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.

Condition or disease Intervention/treatment Phase
Intraoperative Complications Drug: Epidural bupivacaine (dose/concentration/volume ranging) Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Sympathectomy-Mediated Vasodilatation and Differential Sensory Block After Epidural Bupivacaine: a Randomized Concentration Ranging Study
Study Start Date : March 1999
Study Completion Date : September 1999

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. 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. 1. Other indices of sympathectomy:
  2. a. Photoplethysmography derived baseline change (ln (Blepi/Blo));
  3. b. Photoplethysmography derived time lag between pulse reaching hand and foot;
  4. c. Blood pressure (mean, systolic, diastolic);
  5. d. Skin temperature changes (finger and toe temperature change from baseline, toe-thigh and finger-arm temperature gradients).
  6. 2. Sensory level (pinprick, touch, cold)
  7. 3. Motor block (Bromage scale)
  8. All assessments made at 0, 5, 10 and 20 minutes after epidural drug administration.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00197353

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

Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00197353     History of Changes
Other Study ID Numbers: PPG1-ginosar-HMO-CTIL
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: March 6, 2009
Last Verified: May 2005

Keywords provided by Hadassah Medical Organization:
Anesthesia, Epidural
Dose-Response Relationship, Drug

Additional relevant MeSH terms:
Intraoperative Complications
Pathologic Processes
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents