Superficial Cervical Plexus BlockNCT05252832
Superficial Cervical Plexus Block for IJCL Pain Management
A study testing Superficial Cervical Plexus Block and Local Infiltrate in people with Superficial Cervical Plexus Block and Pain, run by Cleveland Clinic Akron General at 1 site in United States.
Trial summary
This is a prospective randomized trial evaluating the effect of SCPB on reported patient pain following IJCL placement as compared to local infiltrate. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Superficial Cervical Plexus Block, Pain
- What is being tested?
- Superficial Cervical Plexus Block and Local Infiltrate
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2022to 31 Dec 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are 18 years and older, and;
- Present to the Akron General Emergency Department (Main) between March 1, 2021 and December 1, 2022, and;
- Require IJVC as a part of their clinical care.
Who cannot join
- Patients who are intubated; or
- Patients who undergo CPR; or
- Patients who have an allergy to lidocaine or bupivacaine; or
- Patients who have a contraindication to receiving a superficial cervical plexus block such as cellulitis over Erb's point or the internal jugular vein, abnormal anatomy, or prior surgery to the area.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Efficacy of the Superficial Cervical Plexus Block in Reducing Pain Associated With Internal Jugular Central Lines
This is a prospective randomized trial evaluating the effect of SCPB on reported patient pain following IJCL placement as compared to local infiltrate.
Read the detailed description
The goal of this study is to determine if SCPBs provide more pain control than local infiltrate of anesthetic for internal jugular venous cannulation. The investigators hypothesis that patients who receive the SCPB will have a lower VAS rating on average than those who receive local infiltration following internal jugular venous cannulation. To test this, the investigators will be approaching eligible patients for inclusion in a research study. If the patients consent, the patients will be randomly assigned the standard of care treatment or the SCPB. The investigators will then ask the patients to rate pain following insertion of the central line. The investigators will also evaluate different aspects of the patient's hospital course to evaluate their outcomes.
- Conditions
- Superficial Cervical Plexus Block, Pain
- Being tested
- Superficial Cervical Plexus Block, Local Infiltrate
- Keywords
- Superficial Cervical Plexus Block, Pain Management
- Medical subject headings
- Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Superficial Cervical Plexus BlockProcedure or surgery
Location of injection for block.
Local InfiltrateProcedure or surgery
Local infiltration location.
| Study group | Role | What they receive |
|---|---|---|
| Local Infitrate | Active comparator | Not described Receives: Procedure: Local Infiltrate |
| SCPB | Experimental | Not described Receives: Procedure: Superficial Cervical Plexus Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale Rating
The average Visual Analog Scale (VAS) rating in patients who receive the SCPB during internal jugular venous cannulation versus the average VAS in patients receiving local infiltration. The scale is from 0-10, with 0 meaning no pain and 10 meaning the most pain I have ever experienced.
Measured: 30 minutes post central line placement
Secondary outcomes (1)
Complications
To determine if SCPBs are associated with higher complication rates than local infiltration with internal jugular venous cannulation. Complications will be defined as arterial injury, lacerations of the vena cava, mediastinal vessels, and right atrium, hematoma formation, retained guide wire, pulmonary complications including pneumothorax, pneumomediastinum, chylothorax, tracheal injury, injury to the recurrent laryngeal nerve, and air embolus, tracheal injury, arrhythmia, cardiac arrest, device dysfunction, device infection, and venous thrombosis.
Measured: Duration of emergency department and inpatient encounter, typically no more than 7 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2022
- Study start15 Jan 2022
- Primary completion20 Jan 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Superficial Cervical Plexus BlockStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participant blinded block randomization of the control local infitrate (Arm 1) and the experimental SCPB (Arm 2).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cleveland Clinic Akron General
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Stenberg, Cleveland Clinic Akron General
- Investigators
- Robert Stenberg, MD, Principal investigator, Cleveland Clinic Akron General
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05252832
- Sponsor's protocol ID
- 21003
- Status last verified
- Apr 2025
- First submitted
- 7 Dec 2021
- Last updated
- 4 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of the Superficial Cervical Plexus Block in Reducing Pain Associated With Internal Jugular Central Lines
- ClinicalTrials.gov ID
- NCT05252832
- Acronym / sponsor ID
- 21003
- Conditions
- Superficial Cervical Plexus Block, Pain
- Keywords
- Superficial Cervical Plexus Block, Pain Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Cleveland Clinic Akron GeneralUniversity, hospital or other
- Study start
- 15 Jan 2022 (actual)
- Primary completion
- 20 Jan 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 23 Feb 2022 (actual)
- 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.
This is a prospective randomized trial evaluating the effect of SCPB on reported patient pain following IJCL placement as compared to local infiltrate.
Detailed description
The goal of this study is to determine if SCPBs provide more pain control than local infiltrate of anesthetic for internal jugular venous cannulation. The investigators hypothesis that patients who receive the SCPB will have a lower VAS rating on average than those who receive local infiltration following internal jugular venous cannulation. To test this, the investigators will be approaching eligible patients for inclusion in a research study. If the patients consent, the patients will be randomly assigned the standard of care treatment or the SCPB. The investigators will then ask the patients to rate pain following insertion of the central line. The investigators will also evaluate different aspects of the patient's hospital course to evaluate their outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participant blinded block randomization of the control local infitrate (Arm 1) and the experimental SCPB (Arm 2).
| Arm | Type | Receives |
|---|---|---|
| Local Infitrate | Active comparator | Procedure: Local Infiltrate |
| SCPB | Experimental | Procedure: Superficial Cervical Plexus Block |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who are 18 years and older, and;
- Present to the Akron General Emergency Department (Main) between March 1, 2021 and December 1, 2022, and;
- Require IJVC as a part of their clinical care.
Key exclusion criteria (4 listed)
- Patients who are intubated; or
- Patients who undergo CPR; or
- Patients who have an allergy to lidocaine or bupivacaine; or
- Patients who have a contraindication to receiving a superficial cervical plexus block such as cellulitis over Erb's point or the internal jugular vein, abnormal anatomy, or prior surgery to the area.
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 BlockLocation of injection for block. | Procedure or surgery | SCPB |
| Local InfiltrateLocal infiltration location. | Procedure or surgery | Local Infitrate |
Primary outcome
Visual Analog Scale Rating
Time frame: 30 minutes post central line placement
The average Visual Analog Scale (VAS) rating in patients who receive the SCPB during internal jugular venous cannulation versus the average VAS in patients receiving local infiltration. The scale is from 0-10, with 0 meaning no pain and 10 meaning the most pain I have ever experienced.
1 secondary outcome
Complications
Time frame: Duration of emergency department and inpatient encounter, typically no more than 7 days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2025.
- Individual participant dataSharing planned: No
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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.
Robert Stenberg, MD principal investigator
Cleveland Clinic Akron General
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 and Local Infiltrate in people with Superficial Cervical Plexus Block and Pain, run by Cleveland Clinic Akron General 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 4 May 2025. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Visual Analog Scale Rating (time frame: 30 minutes post central line placement). 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 4 May 2025.