NCT05252832

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 7, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

January 15, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 23, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2024

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

May 4, 2025

Status Verified

April 1, 2025

Enrollment Period

2 years

First QC Date

December 7, 2021

Last Update Submit

May 1, 2025

Conditions

Keywords

Superficial Cervical Plexus BlockPain Management

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Complications

    Duration of emergency department and inpatient encounter, typically no more than 7 days.

Study Arms (2)

Local Infitrate

ACTIVE COMPARATOR
Procedure: Local Infiltrate

SCPB

EXPERIMENTAL
Procedure: Superficial Cervical Plexus Block

Interventions

Location of injection for block.

SCPB

Local infiltration location.

Local Infitrate

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic Akron General

Akron, Ohio, 44307, United States

Location

MeSH Terms

Conditions

PainAgnosia

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Study Officials

  • Robert Stenberg, MD

    Cleveland Clinic Akron General

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participant blinded block randomization of the control local infitrate (Arm 1) and the experimental SCPB (Arm 2).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator, Ultrasound Director, Assistant Professor, Emergency Medicine Physician

Study Record Dates

First Submitted

December 7, 2021

First Posted

February 23, 2022

Study Start

January 15, 2022

Primary Completion

January 20, 2024

Study Completion

December 31, 2024

Last Updated

May 4, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations