Neuralgia,PostherpeticPhase 4NCT03995563
The Effect of Epidural Steroid Use in Patients With Continous Epidural Block in PHN Patients.
A Phase 4 study testing Dexamethasone and Ropivacaine in people with Neuralgia,Postherpetic, run by Korea University Guro Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Neuralgia,Postherpetic
- What is being tested?
- Dexamethasone and Ropivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 May 2019to 30 Nov 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Kangnam sacred heart hospital
Seoul, Yeongdeungpo-gu, 07441
Jung Eun Kim, MD, PhD, +82-10-7271-5391, geri200@gmail.com
About this study
Official title: The Effect of Epidural Steroid Use on Pain Relief in Patients With Continuous Epidural Nerve Block in Postherpetic Neuralgia Patients.
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.
Read the 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
- Conditions
- Neuralgia,Postherpetic
- Being tested
- Dexamethasone, Ropivacaine
- Medical subject headings
- Neuralgia, Postherpetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Also called DEXA-S
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.
.
RopivacaineDrug
Also called Rocaine
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
| Study group | Role | What they receive |
|---|---|---|
| D group | Active comparator | 0.19% Ropivacaine 8mL + Dexametasone 1mg every other day injection during 10 days Receives: Drug: Dexamethasone; Drug: Ropivacaine |
| N group | Placebo comparator | 0.19% Ropivacaine 8mL only every other day injection during 10 days Receives: Drug: Ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS score
The investigator set the primary outcome If there is a 50% reduction of VAS score.
Measured: up to 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2019
- Study start15 May 2019
- Primary completion30 May 2020 (estimated)
- Study completion30 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuralgia,PostherpeticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korea University Guro Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jung Eun Kim, Korea University Guro Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03995563
- Sponsor's protocol ID
- 2019-04-011
- Status last verified
- Jun 2019
- First submitted
- 21 Jun 2019
- Last updated
- 24 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD sharing is not decided.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Epidural Steroid Use on Pain Relief in Patients With Continuous Epidural Nerve Block in Postherpetic Neuralgia Patients.
- ClinicalTrials.gov ID
- NCT03995563
- Acronym / sponsor ID
- 2019-04-011
- Conditions
- Neuralgia,Postherpetic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Korea University Guro HospitalUniversity, hospital or other
- Study start
- 15 May 2019 (actual)
- Primary completion
- 30 May 2020 (estimated)
- Study completion
- 30 Nov 2020 (estimated)
- First posted
- 24 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| D group | Active comparator | Drug: Dexamethasone, Drug: Ropivacaine0.19% Ropivacaine 8mL + Dexametasone 1mg every other day injection during 10 days |
| N group | Placebo comparator | Drug: Ropivacaine0.19% Ropivacaine 8mL only every other day injection during 10 days |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexamethasoneAlso: DEXA-SContinous 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. . | Drug | D group |
| RopivacaineAlso: RocaineContinous epidural injection will be done during 10 days Both group will be injected a 0.19% ropivacaine 8mL every other day during 10 days | Drug | D group, N group |
Primary outcome
VAS score
Time frame: up to 10 days
The investigator set the primary outcome If there is a 50% reduction of VAS score.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2019.
- Individual participant dataSharing planned: Undecided. IPD sharing is not decided.
Related trials for Neuralgia,Postherpetic
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Active, not recruitingObservational study
Obesity and Obesity-Related Factors and Risk of Herpes Zoster (Shingles) and Postherpetic Neuralgia
Herpes Zoster (HZ)
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The Analgesic Efficacy and Safety of Venlafaxine for Prevention of Postherpetic Neuralgia in Patients With Acute Herpes Zoster
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Efficacy and Safety of Intravenous Dexamethasone Palmitate Treatments in Acute and Subacute Herpes Zoster Pain
Herpes Zoster Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexamethasone and Ropivacaine in people with Neuralgia,Postherpetic, run by Korea University Guro Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jung Eun Kim, MD, PhD (+82-10-7271-5391, geri200@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS score (time frame: up to 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2019.