NCT01473667

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

November 14, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 17, 2011

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

February 1, 2019

Status Verified

January 1, 2019

Enrollment Period

3.3 years

First QC Date

November 14, 2011

Last Update Submit

January 31, 2019

Conditions

Pacemaker InsertionRegional BlockPain

Outcome Measures

Primary Outcomes (1)

  • To decrease opioid requirements after Pacemaker insertion

    first 24 hrs post pacemaker insertion

Study Arms (2)

Superficial Cervical Plexus Block

ACTIVE COMPARATOR
Procedure: Superficial Cervical Plexus Block (SCP) block

Local Infiltration

ACTIVE COMPARATOR
Procedure: Local site infiltration

Interventions

Superficial Cervical Plexus Block (SCP) blockPROCEDURE

SCP block using 10-15ml of 1% Ropivacaine

Superficial Cervical Plexus Block
Local site infiltrationPROCEDURE

Local site infiltration using 2% lidocaine

Local Infiltration

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-100 years old
  • Registered patients at Mayo Clinic in Florida scheduled to undergo primary insertion of pacemaker

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

MeSH Terms

Conditions

Pain

Interventions

UrocortinsDental Occlusion

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Peptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsDentistryDental Physiological PhenomenaDigestive System and Oral Physiological Phenomena

Study Officials

  • Christopher Robards, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

November 14, 2011

First Posted

November 17, 2011

Study Start

November 1, 2011

Primary Completion

March 1, 2015

Study Completion

September 1, 2016

Last Updated

February 1, 2019

Record last verified: 2019-01

Locations

US(1)