Comparison of Pain Relief Between High Thoracic Erector S... | NCT05487326

Studies
Comparison of Pain Relief Between High Thoracic Erector Spinae Plane Block and Cervical Epidural Injection

NCT05487326

Sponsor

Keimyung University Dongsan Medical Center

Status

Unknown status

Last Update Posted

Apr 5, 2023Actual

Enrollment

82Estimated

Phase

Not Applicable

Conditions

Pain, Chronic

Interventions

Erector spinae plane block
cervical epidural injection

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

Apr 2023

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

Aug 7, 2022Actual

Primary Completion Date

Apr 30, 2023Estimated

Completion Date

Apr 30, 2023Estimated

First Submitted Date

Aug 1, 2022

First Submission Date that Met QC Criteria

Aug 2, 2022

First Posted Date

Aug 4, 2022Actual

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 2, 2023

Last Update Posted Date

Apr 5, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ji Hee Hong, Professor, Keimyung University Dongsan Medical CenterPrincipal Investigator

Lead Sponsor

Keimyung University Dongsan Medical CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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 primary endpoint of this study was to identify whether there is a pain improving effect of high thoracic eretor spinae plane block (ESPB) when compared with cervical epidural injection

Detailed Description

The erector spinae plane block (ESPB) is a less invasive, safer, and technically easy alternative procedure to conventional neuraxial anesthetic techniques. In contrast to common neuraxial techniques such as paravertebral and epidural injections, the ESPB targets an interfascial plane which is far from the spinal cord, root, and pleura. First applied to thoracic neuropathic pain, currently ESPB is being applied to postoperative pain control and includes variable clinical situations. In the abdomen and thoracic wall, thoracic ESPB can be applied for pain control after cardiac surgery, video-assisted thoracic surgery, laparoscopic cholecystectomy, and thoracotomy. Recently, favorable postoperative pain control after lumbar spinal or lower limb surgeries has been reported with lumbar ESPB. In addition, ESPB has also been used for chronic pain conditions in the upper and lower extremities. To investigate the possible mechanism of action of the ESPB, many previous studies have focused on examining the physical spread of the injected agent. Commonly, contrast dye injections in human cadavers have been utilized to assess the spread level. Physical spread level was determined using various methods including direct dissection or sectioning, computed tomography (CT), thoracoscopic inspection, or magnetic resonance imaging (MRI) with radiocontrast injection. Apart from human cadaver studies, physical spread level has been evaluated in alive patients using a variable volume of local anesthetics mixed with radiocontrast. However, these studies are limited by the small number of included patients.

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

82Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
high thoracic ESPB group	Active Comparator	Group where ESPB is performed at T2 with local anesthetic mixture 20 ml	Procedure: Erector spinae plane block
cervical epidural group	Active Comparator	Group where cervical epidural injection is performed at C6-7 or C7-T1 level	Procedure: cervical epidural injection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Erector spinae plane block	Procedure	fascial plane injection guided by ultrasound guidance	high thoracic ESPB group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changes of numerical rating scale	Changes of 11-point numerical rating scale (0-10)	baseline, 10 min after injection, 1wk after injection, 2 wks after injection, 4 wks after injection, 8 wks after injection

Secondary Outcomes

Measure	Description	Time Frame
Changes of neck disability index	Changes of back pain funtional scale	baseline, 8 wks after injection

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

cervical spinal stenosis
cervical intervertebral disc herniation
cervical facet arthropathy
cervical foraminal stenosis

Exclusion Criteria:

Allergy to local anesthetics or contrast medium
Pregnancy
Spine deformity
Patients with coagulation abnormality

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ji H Hong, Ph.D	Contact	01046794343		swon13@daum.net
Sung W Jung	Contact	01021064343		swon12@daum.net

Overall Officials

Name	Affiliation	Role
Ji H Hong, Ph.D	Keimyung University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hong ji HEE	Recruiting	Daegu		42601	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D059350	Chronic Pain
D010146	Pain

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

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