- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05252832
Superficial Cervical Plexus Block for IJCL Pain Management
May 1, 2025 updated by: Robert Stenberg, Cleveland Clinic Akron General
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
14
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ohio
-
Akron, Ohio, United States, 44307
- Cleveland Clinic Akron General
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: SCPB
|
Location of injection for block.
|
|
Active Comparator: Local Infitrate
|
Local infiltration location.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
30 minutes post central line placement
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Complications
Time Frame: Duration of emergency department and inpatient encounter, typically no more than 7 days.
|
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.
|
Duration of emergency department and inpatient encounter, typically no more than 7 days.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Robert Stenberg, MD, Cleveland Clinic Akron General
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 15, 2022
Primary Completion (Actual)
January 20, 2024
Study Completion (Actual)
December 31, 2024
Study Registration Dates
First Submitted
December 7, 2021
First Submitted That Met QC Criteria
February 14, 2022
First Posted (Actual)
February 23, 2022
Study Record Updates
Last Update Posted (Actual)
May 4, 2025
Last Update Submitted That Met QC Criteria
May 1, 2025
Last Verified
April 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- 21003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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