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Superficial Cervical Plexus Block for IJCL Pain Management

Primary Purpose

Superficial Cervical Plexus Block, Pain

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Superficial Cervical Plexus Block
Local Infiltrate
Sponsored by
Cleveland Clinic Akron General
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Superficial Cervical Plexus Block focused on measuring Superficial Cervical Plexus Block, Pain Management

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cleveland Clinic Akron GeneralRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Local Infitrate

SCPB

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
December 7, 2021
Last Updated
August 3, 2023
Sponsor
Cleveland Clinic Akron General
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1. Study Identification

Unique Protocol Identification Number
NCT05252832
Brief Title
Superficial Cervical Plexus Block for IJCL Pain Management
Official Title
Evaluation of the Efficacy of the Superficial Cervical Plexus Block in Reducing Pain Associated With Internal Jugular Central Lines
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 15, 2022 (Actual)
Primary Completion Date
December 20, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cleveland Clinic Akron General

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Superficial Cervical Plexus Block, Pain
Keywords
Superficial Cervical Plexus Block, Pain Management

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participant blinded block randomization of the control local infitrate (Arm 1) and the experimental SCPB (Arm 2).
Masking
Participant
Masking Description
Participants will be masked to the anesthesia route selected until after they report their pain scale report. Care provider cannot be blinded in order to complete.
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Local Infitrate
Arm Type
Active Comparator
Arm Title
SCPB
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Superficial Cervical Plexus Block
Intervention Description
Location of injection for block.
Intervention Type
Procedure
Intervention Name(s)
Local Infiltrate
Intervention Description
Local infiltration location.
Primary Outcome Measure Information:
Title
Visual Analog Scale Rating
Description
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.
Time Frame
30 minutes post central line placement
Secondary Outcome Measure Information:
Title
Complications
Description
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.
Time Frame
Duration of emergency department and inpatient encounter, typically no more than 7 days.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Robert Stenberg, MD
Phone
330-344-6306
Email
stenber@ccf.org
First Name & Middle Initial & Last Name or Official Title & Degree
Jessica Krizo, PhD
Phone
330-344-6316
Email
krizoj@ccf.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Stenberg, MD
Organizational Affiliation
Cleveland Clinic Akron General
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic Akron General
City
Akron
State/Province
Ohio
ZIP/Postal Code
44307
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica Krizo
Phone
330-344-6316

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Superficial Cervical Plexus Block for IJCL Pain Management

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