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Completed

NCT Number: NCT00586248

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic Jacksonville

Jacksonville, Florida, 32224, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age greater than 18, ASA II or III status

Exclusion criteria

  • Pregnancy, unable to provide informed consent

Treatment and study plan

Primary outcomes

  1. Over sensing of pacemaker during nerve stimulation

    Time frame: during nerve stimulation

Secondary outcomes

  1. Pacemaker mode change during nerve stimulation

    Time frame: during nerve stimulation

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

A Pilot Study on Pacemaker Interference From Peripheral Nerve Stimulator for

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Jan 4, 2008
Registry last updated
Jan 4, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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