The Effect of Epidural Steroid Use in Patients With Conti... | NCT03995563

Studies
The Effect of Epidural Steroid Use in Patients With Continous Epidural Block in PHN Patients.

NCT03995563

Sponsor

Korea University Guro Hospital

Status

Unknown status

Last Update Posted

Jun 24, 2019Actual

Enrollment

40Estimated

Phase

Phase 4

Conditions

Neuralgia,Postherpetic

Interventions

Dexamethasone
Ropivacaine

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

Jun 2019

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

May 15, 2019Actual

Primary Completion Date

May 30, 2020Estimated

Completion Date

Nov 30, 2020Estimated

First Submitted Date

Jun 21, 2019

First Submission Date that Met QC Criteria

Jun 21, 2019

First Posted Date

Jun 24, 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

Jun 21, 2019

Last Update Posted Date

Jun 24, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jung Eun Kim, Assistant professor, Korea University Guro HospitalPrincipal Investigator

Lead Sponsor

Korea University Guro HospitalOTHER

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 efficiency of epidural steroid injection in patients who has postherpetic neuralgia is well known. In this study, the purpose is whether the continous epidural steroid injection is effective or not.

Detailed Description

Continous epidural injection will be done during 10 days. D group will be injected a 0.19% ropivacaine 8mL and dexametasone 1mg every other day during 10 days.

Continous epidural injection will be done during 10 days N group will be injected a 0.19% ropivacaine 8mL only every other day during 10 days

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
D group	Active Comparator	0.19% Ropivacaine 8mL + Dexametasone 1mg every other day injection during 10 days	Drug: Dexamethasone Drug: Ropivacaine
N group	Placebo Comparator	0.19% Ropivacaine 8mL only every other day injection during 10 days	Drug: Ropivacaine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dexamethasone	Drug	Continous epidural injection will be done during 10 days. D group will be injected a 0.19% ropivacaine 8mL and dexametasone 1mg every other day during 10 days. .

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
VAS score	The investigator set the primary outcome If there is a 50% reduction of VAS score.	up to 10 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who has herpes zoster
Patients has a period (at least 1month) after onset of herpes zoster
Patients has a definite symptom along dermatome
ASA class I - II
Age : 18 - 80 years

Exclusion Criteria:

Patients who has a cancer
Patients who has a neurologic, psychologic, renal, hepatic and hematologic disease
Patients who has a other dermatologic disease
Patients who has major operation & procedure history
Patients who has a other pain origin
Patients who can not be inserted epidural catheter

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 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
Jung Eun Kim, MD, PhD	Contact	+82-10-7271-5391		geri200@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kangnam sacred heart hospital	Recruiting	Seoul	Yeongdeungpo-gu	07441	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

IPD sharing is not decided.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D051474	Neuralgia, Postherpetic

Ancestor Terms

ID	Term
D009437	Neuralgia
D010523	Peripheral Nervous System Diseases
D009468	Neuromuscular Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003907	Dexamethasone
D000077212	Ropivacaine

Ancestor Terms

ID	Term
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids

Browse Leaves

Not provided

Browse Branches

Not provided