Pacemaker InsertionNCT01473667
Superficial Cervical Plexus Block for Pacemaker Insertion
A study testing Superficial Cervical Plexus Block (SCP) block and Local site infiltration in people with Pacemaker Insertion and Regional Block, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Pacemaker Insertion, Regional Block, Pain
- What is being tested?
- Superficial Cervical Plexus Block (SCP) block and Local site infiltration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-100 years old
- Registered patients at Mayo Clinic in Florida scheduled to undergo primary insertion of pacemaker
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Pacemaker Insertion, Regional Block, Pain
- Being tested
- Superficial Cervical Plexus Block (SCP) block, Local site infiltration
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Superficial Cervical Plexus Block (SCP) blockProcedure or surgery
SCP block using 10-15ml of 1% Ropivacaine
Local site infiltrationProcedure or surgery
Local site infiltration using 2% lidocaine
| Study group | Role | What they receive |
|---|---|---|
| Superficial Cervical Plexus Block | Active comparator | Not described Receives: Procedure: Superficial Cervical Plexus Block (SCP) block |
| Local Infiltration | Active comparator | Not described Receives: Procedure: Local site infiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
To decrease opioid requirements after Pacemaker insertion
Measured: first 24 hrs post pacemaker insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionMar 2015
- Study completionSep 2016
Why it stopped: change in practice occured
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pacemaker InsertionStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher B. Robards, Mayo Clinic
- Investigators
- Christopher Robards, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01473667
- Sponsor's protocol ID
- 11-005969
- Status last verified
- Jan 2019
- First submitted
- 14 Nov 2011
- Last updated
- 1 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Superficial Cervical Plexus Block for Pacemaker Insertion
- ClinicalTrials.gov ID
- NCT01473667
- Acronym / sponsor ID
- 11-005969
- Conditions
- Pacemaker Insertion, Regional Block, Pain
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: change in practice occured
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Nov 2011 (actual)
- Primary completion
- Mar 2015 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 17 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Superficial Cervical Plexus Block | Active comparator | Procedure: Superficial Cervical Plexus Block (SCP) block |
| Local Infiltration | Active comparator | Procedure: Local site infiltration |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18-100 years old
- Registered patients at Mayo Clinic in Florida scheduled to undergo primary insertion of pacemaker
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Superficial Cervical Plexus Block (SCP) blockSCP block using 10-15ml of 1% Ropivacaine | Procedure or surgery | Superficial Cervical Plexus Block |
| Local site infiltrationLocal site infiltration using 2% lidocaine | Procedure or surgery | Local Infiltration |
Primary outcome
To decrease opioid requirements after Pacemaker insertion
Time frame: first 24 hrs post pacemaker insertion
Results and safety
The study was stopped early (reason given: change in practice occured). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Robards, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Superficial Cervical Plexus Block (SCP) block and Local site infiltration in people with Pacemaker Insertion and Regional Block, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: change in practice occured). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To decrease opioid requirements after Pacemaker insertion (time frame: first 24 hrs post pacemaker insertion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2019.