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Superficial Cervical Plexus Block for Pacemaker Insertion

This study has been terminated.
(change in practice occured)
Information provided by (Responsible Party):
Christopher B. Robards, Mayo Clinic Identifier:
First received: November 14, 2011
Last updated: November 5, 2015
Last verified: November 2015
The purpose of this study is to investigate clinical outcomes from two current standard of care pain control procedures performed for patients undergoing pacemaker insertion.

Condition Intervention
Pacemaker Insertion Regional Block Pain Procedure: Superficial Cervical Plexus Block (SCP) block Procedure: Local site infiltration

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Superficial Cervical Plexus Block for Pacemaker Insertion

Further study details as provided by Christopher B. Robards, Mayo Clinic:

Primary Outcome Measures:
  • To decrease opioid requirements after Pacemaker insertion [ Time Frame: first 24 hrs post pacemaker insertion ]

Enrollment: 30
Study Start Date: November 2011
Estimated Study Completion Date: December 2016
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Superficial Cervical Plexus Block Procedure: Superficial Cervical Plexus Block (SCP) block
SCP block using 10-15ml of 1% Ropivacaine
Active Comparator: Local Infiltration Procedure: Local site infiltration
Local site infiltration using 2% lidocaine


Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age 18-100 years old
  • Registered patients at Mayo Clinic in Florida scheduled to undergo primary insertion of pacemaker

Exclusion Criteria:

  • Emergency placement of pacemaker
  • Sub-pectoral placement of pacemaker
  • Patients with history of chronic pain
  • Patients with anatomical abnormality or disruption to the pacemaker insertion site or site of block placement
  • Patients with allergy to local anesthetic
  Contacts and Locations
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Please refer to this study by its identifier: NCT01473667

United States, Florida
Mayo Clinic
Jacksonville, Florida, United States, 32224
Sponsors and Collaborators
Mayo Clinic
Principal Investigator: Christopher Robards, MD Mayo Clinic
  More Information

Responsible Party: Christopher B. Robards, MD, Mayo Clinic Identifier: NCT01473667     History of Changes
Other Study ID Numbers: 11-005969
Study First Received: November 14, 2011
Last Updated: November 5, 2015 processed this record on September 21, 2017