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

September 13, 2005
March 5, 2009
March 1999
Not Provided
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.
Same as current
Complete list of historical versions of study NCT00197353 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Study of Different Concentrations of Epidural Bupivacaine for the Effects on Vasodilatation and Sensory Block
Sympathectomy-Mediated Vasodilatation and Differential Sensory Block After Epidural Bupivacaine: a Randomized Concentration Ranging Study

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Intraoperative Complications
Drug: Epidural bupivacaine (dose/concentration/volume ranging)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
September 1999
Not Provided

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.
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT00197353
PPG1-ginosar-HMO-CTIL
Not Provided
Not Provided
Hadassah Medical Organization
Not Provided
Principal Investigator: Yehuda Ginosar, BSc MBBS Hadassah Medical Organization
Hadassah Medical Organization
May 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP