Superficial Cervical Plexus Block for Pacemaker Insertion

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Christopher B. Robards, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01473667
First received: November 14, 2011
Last updated: July 24, 2014
Last verified: July 2014
  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 2014
Estimated Primary Completion Date: December 2014 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Florida
Mayo Clinic
Jacksonville, Florida, United States, 32224
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: July 24, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on October 16, 2014