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Superficial Cervical Plexus Block for Pacemaker Insertion

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ClinicalTrials.gov Identifier: NCT01473667
Recruitment Status : Terminated (change in practice occured)
First Posted : November 17, 2011
Last Update Posted : November 6, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Pacemaker Insertion Regional Block Pain Procedure: Superficial Cervical Plexus Block (SCP) block Procedure: Local site infiltration

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Superficial Cervical Plexus Block for Pacemaker Insertion
Study Start Date : November 2011
Primary Completion Date : March 2015
Estimated Study Completion Date : December 2016
Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Christopher B. Robards, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01473667     History of Changes
Other Study ID Numbers: 11-005969
First Posted: November 17, 2011    Key Record Dates
Last Update Posted: November 6, 2015
Last Verified: November 2015