US-Guided Superficial Cervical Plexus Block | NCT03933566

Studies
US-Guided Superficial Cervical Plexus Block

NCT03933566

Sponsor

Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine

Status

Completed

Last Update Posted

Apr 9, 2024Actual

Enrollment

200Actual

Phase

Not provided

Conditions

Nerve Block

Interventions

Ultrasound-Guided Superficial Cervical Plexus Block
Landmark-Based Superficial Cervical Plexus Block

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2019Actual

Primary Completion Date

Jun 1, 2020Actual

Completion Date

Aug 1, 2020Actual

First Submitted Date

Dec 29, 2017

First Submission Date that Met QC Criteria

Apr 30, 2019

First Posted Date

May 1, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 8, 2024

Last Update Posted Date

Apr 9, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This retrospective observational study compare ultrasound-guided plane and landmark-based superficial cervical plexus block

Detailed Description

Traditionally, the superficial cervical plexus is blocked using a subcutaneous infiltration of local anesthetics along the posterior border of the sternocleidomastoid muscle.Recently, ultrasound has been used to identify intermuscular planes to carry out transversus abdominis plane and obturator nerve blocks.Thus, to validate this new method, the investigators conducted a retrospective observational study comparing ultrasound and the conventional landmark-based technique for superficial cervical plexus.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ultrasound-Guided		Ultrasound-Guided Superficial Cervical Plexus Block	Procedure: Ultrasound-Guided Superficial Cervical Plexus Block
Landmark-Based		Landmark-Based Superficial Cervical Plexus Block	Procedure: Landmark-Based Superficial Cervical Plexus Block

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ultrasound-Guided Superficial Cervical Plexus Block	Procedure	Ultrasound-Guided Superficial Cervical Plexus Block	Ultrasound-Guided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Success rate	Number of Participants wit absence of pain sensation for all 4 branches of the superficial cervical plexus	At 15 mins after nerve block

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Undergoing surgery of the shoulder and clavicle
Urgent or planned surgery

Exclusion Criteria:

Refused to sign informed consent
Pregnant women
Allergic to the local anesthetic

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

200

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ruizhao Lv, M.D	Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine		Cangzhou	Hebei	061001	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided