Superficial Cervical Plexus Block for Pacemaker Insertion

January 31, 2019 updated by: Christopher B. Robards, Mayo Clinic
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To decrease opioid requirements after Pacemaker insertion
Time Frame: first 24 hrs post pacemaker insertion
first 24 hrs post pacemaker insertion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2011

Primary Completion (ACTUAL)

March 1, 2015

Study Completion (ACTUAL)

September 1, 2016

Study Registration Dates

First Submitted

November 14, 2011

First Submitted That Met QC Criteria

November 16, 2011

First Posted (ESTIMATE)

November 17, 2011

Study Record Updates

Last Update Posted (ACTUAL)

February 1, 2019

Last Update Submitted That Met QC Criteria

January 31, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 11-005969

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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