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

Intraoperative Complications Clinical Trial

Official title:

Sympathectomy-Mediated Vasodilatation and Differential Sensory Block After Epidural Bupivacaine: a Randomized Concentration Ranging Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00197353
• Other study ID #: PPG1-ginosar-HMO-CTIL
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: March 5, 2009
• Start date: March 1999
• Est. completion date: September 1999

Study information

• Verified date: May 2005
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 1999
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Intraoperative Complications

Intervention

Drug:
• Epidural bupivacaine (dose/concentration/volume ranging)

Locations

Country	Name	City	State
Israel	Hadassah Hebrew University Medical Center	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

References & Publications (1)

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. — View Citation

Outcome

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