Superficial Cervical Plexus Block for Pacemaker Insertion | NCT01473667

Studies
Superficial Cervical Plexus Block for Pacemaker Insertion

NCT01473667

Sponsor

Mayo Clinic

Status

Terminated

Last Update Posted

Feb 1, 2019Actual

Enrollment

30Actual

Phase

Not Applicable

Conditions

Pacemaker Insertion
Regional Block
Pain

Interventions

Superficial Cervical Plexus Block (SCP) block
Local site infiltration

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

change in practice occured

Expanded Access Info

Start Date

Nov 2011Actual

Primary Completion Date

Mar 2015Actual

Completion Date

Sep 2016Actual

First Submitted Date

Nov 14, 2011

First Submission Date that Met QC Criteria

Nov 16, 2011

First Posted Date

Nov 17, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 31, 2019

Last Update Posted Date

Feb 1, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Superficial Cervical Plexus Block	Active Comparator		Procedure: Superficial Cervical Plexus Block (SCP) block
Local Infiltration	Active Comparator		Procedure: Local site infiltration

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Superficial Cervical Plexus Block (SCP) block	Procedure	SCP block using 10-15ml of 1% Ropivacaine	Superficial Cervical Plexus Block

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christopher Robards, MD	Mayo Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic		Jacksonville	Florida	32224	United States

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D054832	Urocortins
D003766	Dental Occlusion

Ancestor Terms

ID	Term
D036361	Peptide Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists
D009479	Neuropeptides

Browse Leaves

Not provided

Browse Branches

Not provided