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

Sponsor
Korea University Guro Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03995563
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
18.6
Anticipated Duration (Months)
2.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
The Effect of Epidural Steroid Use on Pain Relief in Patients With Continuous Epidural Nerve Block in Postherpetic Neuralgia Patients.
Actual Study Start Date :
May 15, 2019
Anticipated Primary Completion Date :
May 30, 2020
Anticipated Study Completion Date :
Nov 30, 2020

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: D group

0.19% Ropivacaine 8mL + Dexametasone 1mg every other day injection during 10 days

Drug: Dexamethasone
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. .
Other Names:
  • DEXA-S

    • Drug: Ropivacaine
    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
    Other Names:
  • Rocaine

    		•
    Placebo Comparator: N group

    0.19% Ropivacaine 8mL only every other day injection during 10 days

    Drug: Ropivacaine
    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
    Other Names:
  • Rocaine

    		•

    Outcome Measures

    Primary Outcome Measures

    1. VAS score [up to 10 days]

      The investigator set the primary outcome If there is a 50% reduction of VAS score.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kangnam sacred heart hospital Seoul Yeongdeungpo-gu Korea, Republic of 07441

    Sponsors and Collaborators

    • Korea University Guro Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jung Eun Kim, Assistant professor, Korea University Guro Hospital
    ClinicalTrials.gov Identifier:
    NCT03995563
    Other Study ID Numbers:
    • 2019-04-011
    First Posted:
    Jun 24, 2019
    Last Update Posted:
    Jun 24, 2019
    Last Verified:
    Jun 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Neuralgia
    Neuralgia, Postherpetic
    Dexamethasone
    Ropivacaine

    Study Results

    No Results Posted as of Jun 24, 2019