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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03995563
Recruitment Status : Recruiting
First Posted : June 24, 2019
Last Update Posted : June 24, 2019
Sponsor:
Information provided by (Responsible Party):
Jung Eun Kim, Korea University Guro Hospital

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

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shingles

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




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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03995563


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

Locations
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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
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Responsible Party: Jung Eun Kim, Assistant professor, Korea University Guro Hospital
ClinicalTrials.gov Identifier: NCT03995563    
Other Study ID Numbers: 2019-04-011
First Posted: June 24, 2019    Key Record Dates
Last Update Posted: June 24, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: IPD sharing is not decided.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neuralgia
Neuralgia, Postherpetic
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Dexamethasone
Ropivacaine
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents