Comparison of Methods of Lumbar Sympathetic Ganglion Bloc... | NCT01648543

Studies
Comparison of Methods of Lumbar Sympathetic Ganglion Block: Distance vs Angle

NCT01648543

Sponsor

Yonsei University

Status

Unknown status

Last Update Posted

Jul 24, 2012Estimated

Enrollment

194Estimated

Phase

Not Applicable

Conditions

Lumbar Sympathetic Ganglion Block Indication: Neuropathic Pain, CRPS, Hyperhydrosis Etc.

Interventions

lumbar sympathetic ganglion 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 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2012

Primary Completion Date

Dec 2012Estimated

Completion Date

Dec 2012Estimated

First Submitted Date

Jul 19, 2012

First Submission Date that Met QC Criteria

Jul 23, 2012

First Posted Date

Jul 24, 2012Estimated

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 23, 2012

Last Update Posted Date

Jul 24, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

jong bum Choi, Yonsei University College of Medicine, Yonsei UniversityPrincipal Investigator

Lead Sponsor

Yonsei UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

Lumbar sympathetic ganglion block is used for several neuropathic pain syndromes. The best method of lumbar sympathetic ganglion block is not established. The investigators would compare two methods of lumbar sympathetic ganglion block. One is modified Reid method which's entry point is 7~7.5cm from midline of spinous process of lumbar spine. The other is angular method which's entry angle is 30 degree from anterior-posterior view of C-arm. Comparison modified Reid method with angular method would be helpful for finding best method of lumbar sympathetic ganglion block.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

194Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
block method: angle	Active Comparator	The entry angle of angular method which is one method of lumbar sympathetic ganglion block is 30 degree of anterior-posterior view of C-arm.	Procedure: lumbar sympathetic ganglion block
block method: distance	Active Comparator	The entry point of modified Reid method which is popular method of lumbar sympathetic ganglion block is 7~7.5cm from midline of spinous process of lumbar spine.	Procedure: lumbar sympathetic ganglion block

Interventions

Name	Type	Description	Arm Group Labels	Other Names
lumbar sympathetic ganglion block	Procedure		block method: angle block method: distance

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
temperature change		30min
muscle or vessel shadow		30min

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adults above age of 20
Undergoing lumbar sympathetic ganglion block indication

Exclusion Criteria:

Infection
Bleeding tendency
Previous spinal surgery history
Pregnancy
Illiteracy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jong Bum Choi	Contact	+82-2-2019-6093		ROMEOJB@yuhs.ac

Overall Officials

Name	Affiliation	Role
Jong Bum Choi	Yonsei University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Gangnam Severance Hospital	Recruiting	Seoul			South Korea