Thoracic Postherpetic NeuralgiaNCT03595046
The Evaluation of Erector Spinae Plane Block for the Pain Control of Thoracic Postherpetic Neuralgia
A study testing erector spinae plane block (20 mL of 0.25% ropivacaine with dexamethasone 5mg) and thoracic paravertebral block(10 mL 0.25% ropivacaine with dexamethasone 5mg) in people with Thoracic Postherpetic Neuralgia, run by Yonsei University at 1 site in South Korea.
Trial summary
Erector spinae plane block is new interfascial plane block, and can be applied to management of thoracic neuropathic pain syndromes. The target of needle is deeper(or anterior) to the erector spinae muscle. So it is more safe and simple technique than prior technique, thoracic paravertebral block. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Thoracic Postherpetic Neuralgia
- What is being tested?
- erector spinae plane block (20 mL of 0.25% ropivacaine with dexamethasone 5mg) and thoracic paravertebral block(10 mL 0.25% ropivacaine with dexamethasone 5mg)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2018to 6 Jun 2019
- Phase
- Interventional
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Inclusion criteria were patients who had chest wall post herpetic neuralgia, with moderate and severe pain and received appropriate antiviral therapy.
Who cannot join
- Patient refusal
- Patients who did not receive appropriate antiviral therapy
- Patients with mild pain
- Heavy skin eruption (no healthy area for needle entry) and infection at site of injection.
- Patients with history of renal, hepatic diseases, coagulopathy, diabetes
- Patients taking chemotherapy and/or radiotherapy
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- Patients with history of steroid therapy
- Patients taking narcotic analgesics
- Patient who does not understand the study because of illiteracy or language problems.
- Abnormal findings in peripheral blood test (CBC, ESR, CRP, PT/aPTT)
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Dept. of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
Seoul, 03722
About this study
Erector spinae plane block is new interfascial plane block, and can be applied to management of thoracic neuropathic pain syndromes. The target of needle is deeper(or anterior) to the erector spinae muscle. So it is more safe and simple technique than prior technique, thoracic paravertebral block. The aim of this study is the evaluation of erector spinae plane block comparison to prevertebra block.
Read the detailed description
This study is single-blind because it is not possible to blind the practitioner performing the injection.
Subjects were randomly assigned to the erector spinae plane block group (group E) and the thoracic paravertebral block group (group P) by a random random number table, and the possibilities for belonging to any group were all the same and can not be artificially controlled by researchers.
Before the procedure, a resident who does not know of this study records the patient's pain and painDETECT. and on follow-up four weeks visits, PGIC scale is checked.
The erector spinae plane block or thoracic paravertebral block should be performed after receiving the informed consent of the patient.
Because of the large difference between the skilled and unskilled patients, the procedure in this study is performed by only one skilled practitioner.
- Conditions
- Thoracic Postherpetic Neuralgia
- Being tested
- erector spinae plane block (20 mL of 0.25% ropivacaine with dexamethasone 5mg), thoracic paravertebral block(10 mL 0.25% ropivacaine with dexamethasone 5mg)
- Keywords
- thoracic paravertebral block, erector spinae plane block, thoracic postherpetic neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
erector spinae plane block (20 mL of 0.25% ropivacaine with dexamethasone 5mg)Procedure or surgery
In group E, The patient was placed in a sitting position and a high-frequency linear ultrasound transducer was placed in a longitudinal orientation 3 cm lateral to the thoracic spinous process. Three muscles were identified superficial to the hyperechoic transverse process shadow as follows: trapezius, rhomboid major, and erector spinae. An 8-cm 22-gauge block needle was inserted in a cephalad-to-caudad direction until the tip lay in the interfascial plane between transverse process and erector spinae muscles, as evidenced by visible linear spread of fluid between erector spinae muscles and the bony acoustic shadows of the transverse process. A total of 20 mL of 0.25% ropivacaine with dexamethasone 5mg was injected here.
thoracic paravertebral block(10 mL 0.25% ropivacaine with dexamethasone 5mg)Procedure or surgery
- In group P, an appropriate thoracic spinous precess is located by positioning the probe in the transverse plane. Then the probe is moved laterally to locate the transverse process. The probe is manipulated slightly caudad or cephala to locate the intercostal space. The transverse process is visualized medially with the pleura dipping under the inferolateral aspect. The internal intercostal membrane, which is contiguous with the superior costotransverse ligament, was generally seen as a thin, radiopaque line extending from the transverse process, creating a wedge-shaped pocket, which represents the thoracic paravertebral space. A 22-gauge, facet-tip needle is advanced, in plane, from the lateral aspect of the ultrasound probe. When the needle pierced the internal intercostal membrane, and after aspiration demonstrated the absence of air or blood, 10 mL 0.25% ropivacaine with dexamethasone 5mg deposited in 5-mL increments.
| Study group | Role | What they receive |
|---|---|---|
| erector spinae plane block group (group E) | Experimental | ultrasound-guided erector spinae plane block Receives: Procedure: erector spinae plane block (20 mL of 0.25% ropivacaine with dexamethasone 5mg) |
| thoracic paravertebral block group (group P) | Active comparator | ultrasound-guided thoracic paravertebral block Receives: Procedure: thoracic paravertebral block(10 mL 0.25% ropivacaine with dexamethasone 5mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Pain score (NRS)
- in both groups, the patient is asked to score the pain before the procedure and 4 weeks later. And then the change of pain score is recorded.
- NRS(numeric rating scale, on a scale of 0 to 10, with 0 being no pain at all and 10 being the worst pain imaginable)
Measured: Changes of Pain score from the procedure to 4 weeks
2. painDETECT score
- the patient is asked to painDETECT score the pain before the procedure and 4 weeks later. And then the change of painDETECT score is recorded.
- painDETECT Questionnaire. The first five questions ask about the gradation of pain, scored from 0 to 5 (never = 0, hardly noticed = 1, slightly = 2; moderately = 3, strongly = 4, very strongly = 5). Question 6 asks about the pain course pattern, scored from -1 to 2, depending on which pain course pattern diagram is selected. Question 7 asks about radiating pain, answered as yes or no, and scored as 2 or 0 respectively. The total score summed each subscales is between -1 and 38, indicates the likelihood of a neuropathic pain component. A score less than 12 indicates that pain is unlikely to have a neuropathic component, while a score more than 19 suggests that pain is likely to have a neuropathic component.
Measured: Changes of painDETECT score from the procedure to 4 weeks
3. PGIC, 7 scales(overall improvement of pain relief)
- the patient is asked to PGIC, 7 scales about overall improvement of pain relief 4 weeks later.
- Patient's global impression of change(PGIC) scale. Since beginning treatment at this clinic, the change (if any) in ACTIVITY LIMITATIONS, SYMPTOMS, EMOTIONS, and OVERALL QUALITY OF LIFE, related to your painful condition. (No change =1, almost the same = 2, a little better = 3, somewhat better =4, moderate better =5, better =6, a great deal better =7)
Measured: Changes of PGIC, 7 scales from the procedure to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2018
- Study startJul 2018 (estimated)
- Primary completion6 Apr 2019 (estimated)
- Study completion6 Jun 2019 (estimated)
Why it stopped: It was difficult to recruit subjects.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic Postherpetic NeuralgiaStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- erector spinae plane block group (group E) thoracic paravertebral block group (group P)
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03595046
- Sponsor's protocol ID
- 4-2018-0383
- Status last verified
- Feb 2019
- First submitted
- 14 Jun 2018
- Last updated
- 12 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of Erector Spinae Plane Block for the Pain Control of Thoracic Postherpetic Neuralgia
- ClinicalTrials.gov ID
- NCT03595046
- Acronym / sponsor ID
- 4-2018-0383
- Conditions
- Thoracic Postherpetic Neuralgia
- Keywords
- thoracic paravertebral block, erector spinae plane block, thoracic postherpetic neuralgia
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: It was difficult to recruit subjects.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jul 2018 (estimated)
- Primary completion
- 6 Apr 2019 (estimated)
- Study completion
- 6 Jun 2019 (estimated)
- First posted
- 23 Jul 2018 (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.
Erector spinae plane block is new interfascial plane block, and can be applied to management of thoracic neuropathic pain syndromes. The target of needle is deeper(or anterior) to the erector spinae muscle. So it is more safe and simple technique than prior technique, thoracic paravertebral block. The aim of this study is the evaluation of erector spinae plane block comparison to prevertebra block.
Detailed description
This study is single-blind because it is not possible to blind the practitioner performing the injection.
Subjects were randomly assigned to the erector spinae plane block group (group E) and the thoracic paravertebral block group (group P) by a random random number table, and the possibilities for belonging to any group were all the same and can not be artificially controlled by researchers.
Before the procedure, a resident who does not know of this study records the patient's pain and painDETECT. and on follow-up four weeks visits, PGIC scale is checked.
The erector spinae plane block or thoracic paravertebral block should be performed after receiving the informed consent of the patient.
Because of the large difference between the skilled and unskilled patients, the procedure in this study is performed by only one skilled practitioner.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- erector spinae plane block group (group E) thoracic paravertebral block group (group P)
| Arm | Type | Receives |
|---|---|---|
| erector spinae plane block group (group E) | Experimental | Procedure: erector spinae plane block (20 mL of 0.25% ropivacaine with dexamethasone 5mg)ultrasound-guided erector spinae plane block |
| thoracic paravertebral block group (group P) | Active comparator | Procedure: thoracic paravertebral block(10 mL 0.25% ropivacaine with dexamethasone 5mg)ultrasound-guided thoracic paravertebral block |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Inclusion criteria were patients who had chest wall post herpetic neuralgia, with moderate and severe pain and received appropriate antiviral therapy.
Key exclusion criteria (10 listed)
- Patient refusal
- Patients who did not receive appropriate antiviral therapy
- Patients with mild pain
- Heavy skin eruption (no healthy area for needle entry) and infection at site of injection.
- Patients with history of renal, hepatic diseases, coagulopathy, diabetes
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 |
|---|---|---|
| erector spinae plane block (20 mL of 0.25% ropivacaine with dexamethasone 5mg)In group E, The patient was placed in a sitting position and a high-frequency linear ultrasound transducer was placed in a longitudinal orientation 3 cm lateral to the thoracic spinous process. Three muscles were identified superficial to the hyperechoic transverse process shadow as follows: trapezius, rhomboid major, and erector spinae. An 8-cm 22-gauge block needle was inserted in a cephalad-to-caudad direction until the tip lay in the interfascial plane between transverse process and erector spinae muscles, as evidenced by visible linear spread of fluid between erector spinae muscles and the bony acoustic shadows of the transverse process. A total of 20 mL of 0.25% ropivacaine with dexamethasone 5mg was injected here. | Procedure or surgery | erector spinae plane block group (group E) |
| thoracic paravertebral block(10 mL 0.25% ropivacaine with dexamethasone 5mg)2) In group P, an appropriate thoracic spinous precess is located by positioning the probe in the transverse plane. Then the probe is moved laterally to locate the transverse process. The probe is manipulated slightly caudad or cephala to locate the intercostal space. The transverse process is visualized medially with the pleura dipping under the inferolateral aspect. The internal intercostal membrane, which is contiguous with the superior costotransverse ligament, was generally seen as a thin, radiopaque line extending from the transverse process, creating a wedge-shaped pocket, which represents the thoracic paravertebral space. A 22-gauge, facet-tip needle is advanced, in plane, from the lateral aspect of the ultrasound probe. When the needle pierced the internal intercostal membrane, and after aspiration demonstrated the absence of air or blood, 10 mL 0.25% ropivacaine with dexamethasone 5mg deposited in 5-mL increments. | Procedure or surgery | thoracic paravertebral block group (group P) |
Primary outcome
1. Pain score (NRS)
Time frame: Changes of Pain score from the procedure to 4 weeks
1. in both groups, the patient is asked to score the pain before the procedure and 4 weeks later. And then the change of pain score is recorded. * NRS(numeric rating scale, on a scale of 0 to 10, with 0 being no pain at all and 10 being the worst pain imaginable)
2. painDETECT score
Time frame: Changes of painDETECT score from the procedure to 4 weeks
2. the patient is asked to painDETECT score the pain before the procedure and 4 weeks later. And then the change of painDETECT score is recorded. * painDETECT Questionnaire. The first five questions ask about the gradation of pain, scored from 0 to 5 (never = 0, hardly noticed = 1, slightly = 2; moderately = 3, strongly = 4, very strongly = 5). Question 6 asks about the pain course pattern, scored from -1 to 2, depending on which pain course pattern diagram is selected. Question 7 asks about radiating pain, answered as yes or no, and scored as 2 or 0 respectively. The total score summed each subscales is between -1 and 38, indicates the likelihood of a neuropathic pain component. A score less than 12 indicates that pain is unlikely to have a neuropathic component, while a score more than 19 suggests that pain is likely to have a neuropathic component.
3. PGIC, 7 scales(overall improvement of pain relief)
Time frame: Changes of PGIC, 7 scales from the procedure to 4 weeks
3. the patient is asked to PGIC, 7 scales about overall improvement of pain relief 4 weeks later. * Patient's global impression of change(PGIC) scale. Since beginning treatment at this clinic, the change (if any) in ACTIVITY LIMITATIONS, SYMPTOMS, EMOTIONS, and OVERALL QUALITY OF LIFE, related to your painful condition. (No change =1, almost the same = 2, a little better = 3, somewhat better =4, moderate better =5, better =6, a great deal better =7)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2019.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing erector spinae plane block (20 mL of 0.25% ropivacaine with dexamethasone 5mg) and thoracic paravertebral block(10 mL 0.25% ropivacaine with dexamethasone 5mg) in people with Thoracic Postherpetic Neuralgia, run by Yonsei University 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 1 inclusion and 10 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: withdrawn, as of the sponsor's last update on 12 Feb 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. Pain score (NRS) (time frame: Changes of Pain score from the procedure to 4 weeks). The study lists 3 primary outcomes in all. 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 12 Feb 2019.