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

Pacemaker, Artificial Clinical Trial

Official title:

A Pilot Study on Pacemaker Interference From Peripheral Nerve Stimulator for

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00586248
• Other study ID #: 06-002237
• Status: Completed
• Phase: N/A
• First received: December 21, 2007
• Last updated: December 21, 2007
• Start date: March 2006
• Est. completion date: October 2007

Study information

• Verified date: May 2007
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• age greater than 18, ASA II or III status

Exclusion Criteria:

• Pregnancy, unable to provide informed consent

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Pacemaker, Artificial

Locations

Country	Name	City	State
United States	Mayo Clinic Jacksonville	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

References & Publications (5)

De Andrés J, Alonso-Iñigo 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. Review. — View Citation

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. Review. German. — View Citation

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. — View Citation

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. — View Citation

Skinner HB. Multimodal acute pain management. Am J Orthop (Belle Mead NJ). 2004 May;33(5 Suppl):5-9. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Over sensing of pacemaker during nerve stimulation		during nerve stimulation	Yes
Secondary	Pacemaker mode change during nerve stimulation		during nerve stimulation	Yes