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

A Pilot Study on Pacemaker Interference From Peripheral Nerve Stimulator for

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

Study Overview

• Status: Completed
• Conditions: Pacemaker, Artificial

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.

• Study Type: Observational
• Enrollment (Actual): 14

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic Jacksonville

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

3rd degree av block atrial fibrilation chf

Description

Inclusion Criteria:

• age greater than 18, ASA II or III status

Exclusion Criteria:

• Pregnancy, unable to provide informed consent

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Over sensing of pacemaker during nerve stimulation	during nerve stimulation

Secondary Outcome Measures

Outcome Measure	Time Frame
Pacemaker mode change during nerve stimulation	during nerve stimulation

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Ruei Hsin D Wang, MD, Mayo Clinic

Publications and helpful links

General Publications

• Skinner HB. Multimodal acute pain management. Am J Orthop (Belle Mead NJ). 2004 May;33(5 Suppl):5-9.
• De Andres J, Alonso-Inigo JM, Sala-Blanch X, Reina MA. Nerve stimulation in regional anesthesia: theory and practice. Best Pract Res Clin Anaesthesiol. 2005 Jun;19(2):153-74. doi: 10.1016/j.bpa.2004.11.002.
• Rasmussen MJ, Hayes DL, Vlietstra RE, Thorsteinsson G. Can transcutaneous electrical nerve stimulation be safely used in patients with permanent cardiac pacemakers? Mayo Clin Proc. 1988 May;63(5):443-5. doi: 10.1016/s0025-6196(12)65639-0.
• O'Flaherty D, Wardill M, Adams AP. Inadvertent suppression of a fixed rate ventricular pacemaker using a peripheral nerve stimulator. Anaesthesia. 1993 Aug;48(8):687-9. doi: 10.1111/j.1365-2044.1993.tb07181.x.
• Kaiser H, Niesel HC, Hans V. [Fundamentals and requirements of peripheral electric nerve stimulation. A contribution to the improvement of safety standards in regional anesthesia]. Reg Anaesth. 1990 Sep;13(7):143-7. German.

Study record dates

Study Major Dates

• Study Start: March 1, 2006
• Primary Completion (Actual): October 1, 2007
• Study Completion (Actual): October 1, 2007

Study Registration Dates

• First Submitted: December 21, 2007
• First Submitted That Met QC Criteria: December 21, 2007
• First Posted (Estimate): January 4, 2008

Study Record Updates

• Last Update Posted (Estimate): January 4, 2008
• Last Update Submitted That Met QC Criteria: December 21, 2007
• Last Verified: May 1, 2007

More Information

Terms related to this study

• Keywords: Peripheral nerve stimulator, cardiac pacemaker
• Other Study ID Numbers: 06-002237