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

Percutaneous Electric Nerve Stimulation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00176111
• Other study ID #: nervstim001
• Status: Terminated
• Phase: Phase 4
• First received: September 12, 2005
• Last updated: November 15, 2005
• Start date: January 2004
• Est. completion date: January 2005

Study information

• Verified date: January 2004
• Source: Heidelberg University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: January 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

ASA 1-2

Exclusion Criteria:

peripheral neuropathy, ASA >2

Study Design

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

Related Conditions & MeSH terms

• Percutaneous Electric Nerve Stimulation

Intervention

Procedure:
• peripheral nerve stimulation (procedure)

Locations

Country	Name	City	State
Germany	Rechbergklinik	Bretten	Baden Wuerttemberg

Sponsors (2)

Lead Sponsor	Collaborator
Heidelberg University	Rechbergklinik Bretten

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Neuburger M, Gültlinger O, Ass B, Büttner J, Kaiser H. [Influence of blockades with local anesthetics on the stimulation ability of a nerve by peripheral nerve stimulation. Results of a randomized study]. Anaesthesist. 2005 Jun;54(6):575-7. German. — View Citation