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

Status Completed

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.

Clinical Trial 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 Design

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

Related Conditions & MeSH terms

• Intraoperative Complications

• NCT number: NCT00197353
• Study type: Interventional
• Source: Hadassah Medical Organization
• Status: Completed
• Phase: Phase 3
• Start date: March 1999
• Completion date: September 1999