A Pilot Study on Pacemaker Interference From Peripheral Nerve Stimulator for Regional Anesthesia

This study has been completed.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00586248
First received: December 21, 2007
Last updated: NA
Last verified: May 2007
History: No changes posted
  Purpose

In this prospective pilot study, we proposed to evaluate the effects of left interscalene stimulation on cardiac pacemaker function.


Condition
Pacemaker, Artificial

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: A Pilot Study on Pacemaker Interference From Peripheral Nerve Stimulator for

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Over sensing of pacemaker during nerve stimulation [ Time Frame: during nerve stimulation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pacemaker mode change during nerve stimulation [ Time Frame: during nerve stimulation ] [ Designated as safety issue: Yes ]

Enrollment: 14
Study Start Date: March 2006
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Detailed Description:

The principle of the nerve stimulation technique consists of using a battery powered peripheral nerve stimulator to generate electrical stimuli through an insulated needle at appropriate anatomical locations. The electrical impulses then trigger depolarization as insulated needle approaches the target nerve bundles. Braun Stimuplex, a common nerve stimulator used for peripheral nerve localization, is currently being used in the United States and other countries. Previous studies have suggested it to be a reliable stimulator for the purpose of peripheral nerve blocks. The operational manual however indicated that this device should not be used in patients with cardiac pacemaker because malfunction of the pacemaker may occur. Literature search on the topic of pacemaker interference from peripheral nerve stimulator showed that there was one case of pacemaker interference caused by activation of a nerve stimulator, resulting in cardiac arrest in a patient with a fixed-rate ventricular pacemaker. Studies and case reports suggest that unipolar electrode seems to be most susceptible to interferences from electrosurgical equipment, TENS unit, spinal cord stimulators. Perhaps this is the reason why the manufacturer of the peripheral nerve stimulator recommends against the use of peripheral nerve stimulator in patients with pacemakers. With the advancements of modern pacemakers technology, it is our experience; interscalene nerve blocks and other peripheral nerve blocks using the nerve stimulator can be performed in patients with pacemakers without notable interferences with pacemaker functions and perhaps the initial recommendation by the peripheral nerve stimulator manufacturer can be modified. In this prospective pilot study, we proposed to evaluate the effects of left interscalene stimulation (most likely scenario to interfere with pacemaker function) by varying the configurations of the pacemaker leads (unipolar vs. bipolar pacer lead configuration) and by varying the positions of the positive electrode of the stimulator.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

3rd degree av block atrial fibrilation chf

Criteria

Inclusion Criteria:

  • age greater than 18, ASA II or III status

Exclusion Criteria:

  • Pregnancy, unable to provide informed consent
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00586248

Locations
United States, Florida
Mayo Clinic Jacksonville
Jacksonville, Florida, United States, 32224
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Ruei Hsin D Wang, MD Mayo Clinic