UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of continuous epidural block in acute herpes zoster and post-herpetic neuralgia
Title of the study (Brief title)	The effect of continuous epidural block in zoster
Region	Asia(except Japan)

Condition
Condition	patients with zoster associated pain
Classification by specialty	Medicine in general Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We aim to investigate whether continuous epidural block is effective for acute and chronic phase of herpes zoster.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	pain relief score (VAS reduction)
Key secondary outcomes	complete remission rate, recurrence rate

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine Device,equipment
Interventions/Control_1	epidural group: zoster patients received the current standard treatment for herpes and continuous epidural block for 14 days (continuous epidural block : continuous infusion of 4mL/h of 0.1% ropivacaine).
Interventions/Control_2	medical group: zoster patients received the current standard treatment for herpes (oral administration of 800 mg acyclovir, 1 times daily for 7 days if the rash had been present for less than 72 hour and analgesics as needed).
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	1) acute herpes zoster patients 2) PHN patients
Key exclusion criteria	1) past or current conditions that could affect the interpretation of the study results, safety, and subject participation including neurological, psychological, cardiac, hepatic, hematological, muscular, dermatological, or genital problems, cancer, or an immunocompromised state; 2) dermatological diseases other than PHN; 3) a medical history of a recent major procedure or surgery; 4) major pain with a cause other than PHN; 5) the presence of a medical device implanted for neuropathic pain such as a spinal cord stimulator, intrathecal pump, or peripheral nerve stimulator; 6) a medical history of spinal bone surgery, which could complicate catheter migration or application; 7) lactating or pregnant women; and 8) patients judged as inappropriate candidates for study participation by the investigator.
Target sample size	332

Research contact person
Name of lead principal investigator	Sang Sik Choi
Organization	Korea University Guro Hospital
Division name	Department of Anesthesiology and Pain Medicine
Address	148, Gurodong-ro, Guro-gu, Seoul, Korea
TEL	8226261870
Email	clonidine@empal.com

Public contact
Name of contact person	Jung Eun Kim
Organization	Korea University Guro Hospital
Division name	Department of Anesthesiology and Pain Medicine
Address	148, Gurodong-ro, Guro-gu, Seoul, Korea
TEL	8226261870
Homepage URL
Email	geri200@gmail.com

Sponsor
Institute	Korea University
Institute
Department

Funding Source
Organization	Korea University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2017 Year 06 Month 30 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2008 Year 01 Month 01 Day
Anticipated trial start date	2008 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 03 Month 30 Day
Last modified on	2017 Year 08 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030747