Superficial Cervical Plexus Block for Pacemaker Insertion

NCT ID: NCT01473667

Last Updated: 2019-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2016-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Pacemaker Insertion Regional Block Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Superficial Cervical Plexus Block

Group Type ACTIVE_COMPARATOR

Superficial Cervical Plexus Block (SCP) block

Intervention Type PROCEDURE

SCP block using 10-15ml of 1% Ropivacaine

Local Infiltration

Group Type ACTIVE_COMPARATOR

Local site infiltration

Intervention Type PROCEDURE

Local site infiltration using 2% lidocaine

Interventions

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Superficial Cervical Plexus Block (SCP) block

SCP block using 10-15ml of 1% Ropivacaine

Intervention Type PROCEDURE

Local site infiltration

Local site infiltration using 2% lidocaine

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Christopher B. Robards

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christopher Robards, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic

Jacksonville, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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11-005969

Identifier Type: -

Identifier Source: org_study_id

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