The Effect of Epidural Steroid Use in Patients With Continous Epidural Block in PHN Patients.
Primary Purpose
Neuralgia,Postherpetic
Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Dexamethasone
Ropivacaine
Sponsored by
About this trial
This is an interventional treatment trial for Neuralgia,Postherpetic
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
Sites / Locations
- Kangnam sacred heart hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
D group
N group
Arm Description
0.19% Ropivacaine 8mL + Dexametasone 1mg every other day injection during 10 days
0.19% Ropivacaine 8mL only every other day injection during 10 days
Outcomes
Primary Outcome Measures
VAS score
The investigator set the primary outcome If there is a 50% reduction of VAS score.
Secondary Outcome Measures
Full Information
NCT ID
NCT03995563
First Posted
June 21, 2019
Last Updated
June 21, 2019
Sponsor
Korea University Guro Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03995563
Brief Title
The Effect of Epidural Steroid Use in Patients With Continous Epidural Block in PHN Patients.
Official Title
The Effect of Epidural Steroid Use on Pain Relief in Patients With Continuous Epidural Nerve Block in Postherpetic Neuralgia Patients.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 15, 2019 (Actual)
Primary Completion Date
May 30, 2020 (Anticipated)
Study Completion Date
November 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Korea University Guro Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuralgia,Postherpetic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
D group
Arm Type
Active Comparator
Arm Description
0.19% Ropivacaine 8mL + Dexametasone 1mg every other day injection during 10 days
Arm Title
N group
Arm Type
Placebo Comparator
Arm Description
0.19% Ropivacaine 8mL only every other day injection during 10 days
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Other Intervention Name(s)
DEXA-S
Intervention 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.
.
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Other Intervention Name(s)
Rocaine
Intervention Description
Continous epidural injection will be done during 10 days Both group will be injected a 0.19% ropivacaine 8mL every other day during 10 days
Primary Outcome Measure Information:
Title
VAS score
Description
The investigator set the primary outcome If there is a 50% reduction of VAS score.
Time Frame
up to 10 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jung Eun Kim, MD, PhD
Phone
+82-10-7271-5391
Email
geri200@gmail.com
Facility Information:
Facility Name
Kangnam sacred heart hospital
City
Seoul
State/Province
Yeongdeungpo-gu
ZIP/Postal Code
07441
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jung Eun Kim, MD, PhD
Phone
+82-10-7271-5391
Email
geri200@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
IPD sharing is not decided.
Learn more about this trial
The Effect of Epidural Steroid Use in Patients With Continous Epidural Block in PHN Patients.
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