Effects of Local Anesthetic or Saline Solution on Peripheral Nerve Stimulation - a Randomised Study

November 15, 2005 updated by: Heidelberg University

Effects of Local Anesthetic or Saline Solution on Peripheral Nerve Stimulation - a Randomised, Double-Blind, Multicenter Study About the Stimulability of Anesthetized Nerves

In this study we want to examine the effect of a small amount of local anesthetic or saline solution on nerve conduction using a peripheral nerve stimulator.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Using electrical nerve stimulation in performing peripheral nerve helps to control the needle position in relation to the nerve and therefore may increase the likelihood of a successful nerve block. Defining the minimal stimulating current accepted also may help to avoid direct contact between nerve and needle or accidental endoneural injection and subsequent nerve lesion.

In recent years there have been many reports where several nerves, parts thereof or plexuses have been anesthetised using a multiple injection approach. That is, nerves in close proximity of each other have been subsequently blocked after using a nerve stimulator to locate them.

It is not clear though, whether a nerve may already be partially anesthetised in this situation and whether that would impair the correct use of a peripheral nerve stimulator.

The aim of this study is to examine the excitability of a peripheral nerve after injecting a small amount of local anesthetic agent or saline solution into the proximity of the nerve.

Study Type

Interventional

Enrollment

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Baden Wuerttemberg
      • Bretten, Baden Wuerttemberg, Germany, 75015
        • Rechbergklinik

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

ASA 1-2

Exclusion Criteria:

peripheral neuropathy, ASA >2

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heidelberg University

Collaborators

Rechbergklinik Bretten

Investigators

  • Study Chair: Heinz Kaiser, MD, Rechbergklinik Bretten

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2004

Study Completion

January 1, 2005

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 15, 2005

Study Record Updates

Last Update Posted (Estimate)

November 17, 2005

Last Update Submitted That Met QC Criteria

November 15, 2005

Last Verified

January 1, 2004

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • nervstim001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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