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Superficial Cervical Plexus Block for Pacemaker Insertion

This study is currently recruiting participants.
Verified January 2013 by Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
Christopher B. Robards, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01473667
First received: November 14, 2011
Last updated: January 8, 2013
Last verified: January 2013
History of Changes
  Purpose

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: Open Label
Official Title: Superficial Cervical Plexus Block for Pacemaker Insertion

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • To decrease opioid requirements after Pacemaker insertion [ Time Frame: first 24 hrs post pacemaker insertion ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: November 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: November 2013 (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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01473667

Contacts
Contact: Christopher Robards, MD 904-956-3327

Locations
United States, Florida
Mayo Clinic Recruiting
Jacksonville, Florida, United States, 32224
Contact: Christopher Robards, MD     904-953-3327        
Principal Investigator: Christopher Robards, MD            
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Christopher Robards, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: Christopher B. Robards, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01473667     History of Changes
Other Study ID Numbers: 11-005969
Study First Received: November 14, 2011
Last Updated: January 8, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on June 17, 2013