Superficial Cervical Plexus Block for Pacemaker Insertion

NCT01473667 — Not applicable, Terminated, 30 participants, Mayo Clinic

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RegistryNCT01473667
StatusTerminated - change in practice occured
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: none, other
Enrollment30 (Actual)
SponsorMayo Clinic (Other)
ConditionsPacemaker Insertion, Regional Block, Pain
InterventionsSuperficial Cervical Plexus Block (SCP) block, Local site infiltration (Procedure)
Datesstart 2011-11-01, primary completion 2015-03-01, completion 2016-09-01, first posted 2011-11-17, last updated 2019-02-01
Locations1 site in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Pacemaker Insertion All trials for Regional Block All trials of Superficial Cervical Plexus Block (SCP) block All trials of Local site infiltration

-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.

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+Arms and interventions

ArmTypeInterventionsDescription
Superficial Cervical Plexus BlockActive comparatorProcedure: Superficial Cervical Plexus Block (SCP) block
Local InfiltrationActive comparatorProcedure: Local site infiltration
  • Superficial Cervical Plexus Block (SCP) block (Procedure): SCP block using 10-15ml of 1% Ropivacaine
  • Local site infiltration (Procedure): Local site infiltration using 2% lidocaine

+Outcome measures

Primary outcomes

  • To decrease opioid requirements after Pacemaker insertion [first 24 hrs post pacemaker insertion]

+Eligibility

Sex: All, ages: 18 Years to 100 Years

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

+Locations (1)

FacilityCityCountryStatus
Mayo ClinicJacksonville, FloridaUnited States

+Investigators