CClinicalTrials.gg
TerminatedNCT01473667Updated Feb 1, 2019

Superficial Cervical Plexus Block for Pacemaker Insertion

An interventional study of Superficial Cervical Plexus Block (SCP) block and Local site infiltration in Pacemaker Insertion, Regional Block and Pain, sponsored by Mayo Clinic. Terminated at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2019-02-01.

Sponsored by Mayo Clinic · Not applicable, Interventional, and Other

Why this study was terminated
change in practice occured
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 100 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Pacemaker Insertion
  • Regional Block
  • Pain
03

In context

Lead sponsor

Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.

Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Active comparator
    Superficial Cervical Plexus Block

    Procedure: Superficial Cervical Plexus Block (SCP) block

  • Active comparator
    Local Infiltration

    Procedure: Local site infiltration

Interventions

  • ProcedureSuperficial Cervical Plexus Block (SCP) block

    SCP block using 10-15ml of 1% Ropivacaine

  • ProcedureLocal site infiltration

    Local site infiltration using 2% lidocaine

06

What researchers measure

Primary outcomes

  1. To decrease opioid requirements after Pacemaker insertion

    Time frame: first 24 hrs post pacemaker insertion

07

Study locations

1 site
  • Mayo Clinic
    Jacksonville, Florida 32224, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 1, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01473667
Lead sponsor
Mayo Clinic
Responsible party
Christopher B. Robards (MD, Mayo Clinic) — Principal investigator
First posted
Nov 17, 2011
Start date
Nov 2011
Primary completion
Mar 2015
Completion
Sep 2016
Last update
Feb 1, 2019

Study contacts

Christopher Robards, MD
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion