4006-776-356 出国就医服务电话

免费获得国外相关药品，最快 1 个工作日回馈药物信息

出境医 / 临床实验 / The Effect of Epidural Steroid Use in Patients With Continous Epidural Block in PHN Patients.

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

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
Neuralgia,Postherpetic Drug: Dexamethasone Drug: Ropivacaine 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
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Primary Completion Date : May 30, 2020
Estimated Study Completion Date : November 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 Name: 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 Name: 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 Name: Rocaine
Outcome Measures
Primary Outcome Measures :
  1. VAS score [ Time Frame: up to 10 days ]
    The investigator set the primary outcome If there is a 50% reduction of VAS score.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Jung Eun Kim, MD, PhD +82-10-7271-5391 geri200@gmail.com

Locations
Layout table for location information
Korea, Republic of
Kangnam sacred heart hospital Recruiting
Seoul, Yeongdeungpo-gu, Korea, Republic of, 07441
Contact: Jung Eun Kim, MD, PhD    +82-10-7271-5391    geri200@gmail.com   
Sponsors and Collaborators
Korea University Guro Hospital
Tracking Information
First Submitted Date  ICMJE June 21, 2019
First Posted Date  ICMJE June 24, 2019
Last Update Posted Date June 24, 2019
Actual Study Start Date  ICMJE May 15, 2019
Estimated Primary Completion Date May 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 21, 2019) 		VAS score [ Time Frame: up to 10 days ]
The investigator set the primary outcome If there is a 50% reduction of VAS score.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Epidural Steroid Use in Patients With Continous Epidural Block in PHN Patients.
Official Title  ICMJE The Effect of Epidural Steroid Use on Pain Relief in Patients With Continuous Epidural Nerve Block in Postherpetic Neuralgia Patients.
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Neuralgia,Postherpetic
Intervention  ICMJE
  • 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 Name: 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 Name: Rocaine
Study Arms  ICMJE
  • Active Comparator: D group
    0.19% Ropivacaine 8mL + Dexametasone 1mg every other day injection during 10 days
    Interventions:
    • Drug: Dexamethasone
    • Drug: Ropivacaine
  • Placebo Comparator: N group
    0.19% Ropivacaine 8mL only every other day injection during 10 days
    Intervention: Drug: Ropivacaine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 21, 2019) 		40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 30, 2020
Estimated Primary Completion Date May 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03995563
Other Study ID Numbers  ICMJE 2019-04-011
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: IPD sharing is not decided.
Responsible Party Jung Eun Kim, Korea University Guro Hospital
Study Sponsor  ICMJE Korea University Guro Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Korea University Guro Hospital
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

治疗医院

新药特效药

前沿医讯