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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05252832
Other study ID # 21003
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 15, 2022
Est. completion date December 31, 2024

Study information

Verified date January 2024
Source Cleveland Clinic Akron General
Contact Robert Stenberg, MD
Phone 330-344-6306
Email stenber@ccf.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date December 31, 2024
Est. primary completion date December 20, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms

  • Pain
  • Superficial Cervical Plexus Block

Intervention

Procedure:
Superficial Cervical Plexus Block
Location of injection for block.
Local Infiltrate
Local infiltration location.

Locations

Country Name City State
United States Cleveland Clinic Akron General Akron Ohio

Sponsors (1)

Lead Sponsor Collaborator
Cleveland Clinic Akron General

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 30 minutes post central line placement
Secondary 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. Duration of emergency department and inpatient encounter, typically no more than 7 days.
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