Comparison of Costoclavicular Brachial Plexus Block and S... | NCT03097159

Studies
Comparison of Costoclavicular Brachial Plexus Block and Supraclavicular Brachial Plexus Block

NCT03097159

Sponsor

Ajou University School of Medicine

Status

Withdrawn

Last Update Posted

Jul 3, 2018Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Phrenic Nerve Paralysis

Interventions

Costoclavicular block

Countries

South Korea

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

Jul 2018

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Surgeon refuse the proposal, so we can's enroll the patients

Expanded Access Info

Start Date

May 1, 2017Actual

Primary Completion Date

Mar 31, 2018Actual

Completion Date

Mar 31, 2018Actual

First Submitted Date

Mar 26, 2017

First Submission Date that Met QC Criteria

Mar 26, 2017

First Posted Date

Mar 31, 2017Actual

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

Jul 1, 2018

Last Update Posted Date

Jul 3, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

In-kyong Yi, Clinical assistant professor, Ajou University School of MedicinePrincipal Investigator

Lead Sponsor

Ajou University School of MedicineOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

The investigator will compare Costoclavicular approach of infraclavicular block and supraclavicular block. Especially, the incidence of phrenic nerve palsy and the quality of block.

Detailed Description

Costoclavicular brachial plexus block is a recently developed approach of infraclavicular brachial plexus block. Using ultrasound, all of 3 cords are well visible in single plane. Compared to conventional infraclavicular block, it needs smaller amount of local anesthetics.

Supraclavicular brachial plexus block is known as spinal anesthesia of upper extremities. It provides fast and good quality of anesthesia and analgesia. But some studies showed that there are over 50% of phrenic nerve palsy in supraclavicular block.

In this study, the investigator will compare phrenic nerve palsy incidence and block quality between Costoclavicular block and supraclavicular block using ultrasound.

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

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Costoclavicular block		For anesthesia, this group of patients will be received ultrasound guided costoclavicular block	Procedure: Costoclavicular block
Supraclavicular block		For anesthesia, this group of patients will be received ultrasound guided supraclavicular block

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Costoclavicular block	Procedure	Group C for costoclavicular block Group S for supraclavicular block	Costoclavicular block

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Diaphragm palsy	Using M-mode of ultrasound, compare diaphragm movement pre-block and 30min after block Paralysis : reduced movement more than 75% or paradoxical movement on sniffing Paresis : 25~75% movement Normal : reduced less than 25%	30 min

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ASA I or II
Scheduled for surgery of hand or forearm

Exclusion Criteria:

Patient refusal
Neuromuscular disease
Pregnancy
Previous history of surgery of periclavicular region
Nerve injury history
Bleeding tendency
Allergy to local anesthetics
Other contraindication of regional anesthesia

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Patients scheduled for surgery of hand or forearm

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
In Kyong Yi, MD	Ajou University School of Medicine	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ajou university school of medicine		Suwon	Gyeonggi-do	16377	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided