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Trial registered on ANZCTR


Registration number
ACTRN12624001149550
Ethics application status
Approved
Date submitted
13/08/2024
Date registered
23/09/2024
Date last updated
23/09/2024
Date data sharing statement initially provided
23/09/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
The Effect of Erector Spinae Plane Block in Herpes Zoster Patients Who Are Ineffective with Conventional Treatment
Scientific title
Effect of Erector Spinae Plane Block Applied to Painful Herpes Zoster Patients Who Failed to Respond to Pregabalin Treatment on Immunological Marker Levels and Postherpetic Neuralgia Incidence Rate
Secondary ID [1] 312742 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain management 334776 0
Herpes zoster 334959 0
Postherpetic neuralgia 334960 0
Condition category
Condition code
Infection 331336 331336 0 0
Other infectious diseases
Inflammatory and Immune System 331337 331337 0 0
Normal development and function of the immune system
Anaesthesiology 331489 331489 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Erector Spinae Plane (ESP) Block Application: The block will be performed at the level of the dermatome involved in the thoracic region. If more than one dermatome is involved, the block will be performed at the middle level of the involved area. Patients will be laid in the prone position and skin preparation will be performed with 10% povidone iodine. Cutaneous-subcutaneous anesthesia will be provided with 3 ml of 2% lidocaine hydrochloride at the targeted injection site. Using a linear probe covered with a sterile drape at 8 mHz frequency under ultrasound guidance, the thoracic vertebral spinous process will first be imaged in the horizontal plane in the midline. The probe will then be turned to the longitudinal plane and the transverse process and the erector spinae muscle will be imaged approximately 3 cm lateral from the midline. The 22-gauge, 80-mm block needle will be advanced craniocaudally in-plane and the transverse process will be touched. The needle will then be minimally withdrawn and its location between the erector spinae muscle and the transverse process will be confirmed by hydro-dissection, and 0.375% bupivacaine hydrochloride will be injected in a volume of 20 ml, and the spread of local anesthetic will be visualized simultaneously by ultrasonography. After 30 minutes, loss of hot and cold sensation below and above the level of the blocked dermatome will be considered as a block success.
An anaesthetist will be administering the block. The block will be administered for each patient once only.
All patients who met the inclusion criteria were started on pregabalin oral tablet treatment at the first application. Patients whose pain could be controlled with appropriate doses of pregabalin treatment and whose Numeric Rating Scale (NRS) score was below 4 formed Group I. Erector spinae plane (ESP) block was performed on patients whose pain could not be controlled with appropriate doses of pregabalin treatment and whose NRS score was 4 and above, and these patients formed Group II. Considering the patients' age, comorbidities, other medications they were using and general conditions, pregabalin treatment was started at a dose of 25 mg twicw daily or 75 mg twice daily, and the patients underwent outpatient clinic check-up 7 days later. Patients with an NRS score below 4 at this check-up continued to use the same dose of medication and were included in Group I. The medication dose of patients with an NRS score of 4 and above was adjusted. The dose of patients using 25 mg twice daily was changed to 75 mg twice daily, and the dose of patients using 75 mg twice daily was changed to 150 mg twice daily, and the patients were called for an outpatient clinic check-up 7 days later. Patients with an NRS score below 4 in this check-up continued to use the same dose of medication and were included in Group I. Patients with an NRS score of 4 and above using 150 mg twice daily pregabalin were included in Group II. The treatment of patients with an NRS score of 4 and above using 75 mg twice daily pregabalin was adjusted to 150 mg twice daily, and an outpatient clinic check-up was performed 7 days later. In this check-up, patients with an NRS score below 4 were included in Group I. Patients with an NRS score of 4 and above were included in Group II. ESP block was performed on the patients in Group II, and the patients were called for an outpatient clinic check-up 1 day later. If the patients' NRS score was still 4 and above at this control, paracetamol and opioid analgesics were added to the treatment. All patients were followed up with a two-week outpatient clinic control and if the NRS score was below 4 at the controls, no change was made in the treatment. If the NRS score was 4 and above, analgesic treatments were arranged. Strong opioids were used at the last stage. If the patient's pain did not respond to this treatment, different interventional methods were planned and these patients were excluded from the study. Again, patients who could not comply with the drugs used due to side effects at any stage of the treatment scheme and whose treatments had to be changed for this reason were also excluded from the study. The last outpatient clinic controls of the patients who responded to the treatment and complied with the treatment were performed at the end of the 3rd month and it was accepted that postherpetic neuralgia (PHN) developed in patients whose pain complaints continued.
Intervention code [1] 329273 0
Treatment: Drugs
Comparator / control treatment
All patients who meet the inclusion criteria will be started on pregabalin treatment at first presentation. Patients whose pain can be controlled with appropriate doses of pregabalin and whose Numeric Rating Scale (NRS) score is below 4 will constitute the Group I.All patients who met the inclusion criteria were started on pregabalin oral tablet treatment at the first application. Patients whose pain could be controlled with appropriate doses of pregabalin treatment and whose Numeric Rating Scale (NRS) score was below 4 formed Group I. Considering the patients' age, comorbidities, other medications they were using and general conditions, pregabalin treatment was started at a dose of 25 mg twicw daily or 75 mg twice daily, and the patients underwent outpatient clinic check-up 7 days later. Patients with an NRS score below 4 at this check-up continued to use the same dose of medication and were included in Group I. The medication dose of patients with an NRS score of 4 and above was adjusted. The dose of patients using 25 mg twice daily was changed to 75 mg twice daily, and the dose of patients using 75 mg twice daily was changed to 150 mg twice daily, and the patients were called for an outpatient clinic check-up 7 days later. Patients with an NRS score below 4 in this check-up continued to use the same dose of medication and were included in Group I. Patients with an NRS score of 4 and above using 150 mg twice daily pregabalin were included in Group II. The treatment of patients with an NRS score of 4 and above using 75 mg twice daily pregabalin was adjusted to 150 mg twice daily, and an outpatient clinic check-up was performed 7 days later. In this check-up, patients with an NRS score below 4 were included in Group I. Patients with an NRS score of 4 and above were included in Group II. ESP block was performed on the patients in Group II, and the patients were called for an outpatient clinic check-up 1 day later.
Control group
Active

Outcomes
Primary outcome [1] 339098 0
Change in CD3 levels
Timepoint [1] 339098 0
First visit 1 day after the block is applied (intervention group) or at the first check-up where it is determined that the patients in the control group have responded to pregabalin treatment and the dose is fixed (control group) At the end of the 3rd month post-baseline
Primary outcome [2] 339231 0
Rate of development of postherpetic neuralgia
Timepoint [2] 339231 0
At the end of the 3 months
Primary outcome [3] 339429 0
Change in CD4 levels
Timepoint [3] 339429 0
First visit 1 day after the block is applied (intervention group) or at the first check-up where it is determined that the patients in the control group have responded to pregabalin treatment and the dose is fixed (control group) At the end of the 3rd month post-baseline
Secondary outcome [1] 438548 0
Change in pain levels
Timepoint [1] 438548 0
Baseline and two weeks post-baseline
Secondary outcome [2] 439179 0
Change in effect of pain on sleep quality
Timepoint [2] 439179 0
Baseline and two weeks post-baseline
Secondary outcome [3] 439180 0
Change in neuropathic pain
Timepoint [3] 439180 0
Baseline and two weeks post-baseline
Secondary outcome [4] 439948 0
Change in CD8 levels This is an additional primary outcome
Timepoint [4] 439948 0
First visit 1 day after the block is applied (intervention group) or at the first check-up where it is determined that the patients in the control group have responded to pregabalin treatment and the dose is fixed (control group) At the end of the 3rd month post-baseline
Secondary outcome [5] 439949 0
Change in FOX3 levels This is an additional primary outcome
Timepoint [5] 439949 0
First visit 1 day after the block is applied (intervention group) or at the first check-up where it is determined that the patients in the control group have responded to pregabalin treatment and the dose is fixed (control group) At the end of the 3rd month post-baseline
Secondary outcome [6] 439950 0
Change in Defective T levels This is an additional primary outcome
Timepoint [6] 439950 0
First visit 1 day after the block is applied (intervention group) or at the first check-up where it is determined that the patients in the control group have responded to pregabalin treatment and the dose is fixed (control group) At the end of the 3rd month post-baseline
Secondary outcome [7] 439951 0
Change in Regulatory T levels This is an additional primary outcome
Timepoint [7] 439951 0
First visit 1 day after the block is applied (intervention group) or at the first check-up where it is determined that the patients in the control group have responded to pregabalin treatment and the dose is fixed (control group) At the end of the 3rd month post-baseline
Secondary outcome [8] 439952 0
Change in Cytotoxic T levels This is an additional primary outcome
Timepoint [8] 439952 0
First visit 1 day after the block is applied (intervention group) or at the first check-up where it is determined that the patients in the control group have responded to pregabalin treatment and the dose is fixed (control group) At the end of the 3rd month post-baseline
Secondary outcome [9] 439953 0
Change in CD57 levels This is an additional primary outcome
Timepoint [9] 439953 0
First visit 1 day after the block is applied (intervention group) or at the first check-up where it is determined that the patients in the control group have responded to pregabalin treatment and the dose is fixed (control group) At the end of the 3rd month post-baseline
Secondary outcome [10] 439954 0
Change in CD56 Bright levels This is an additional primary outcome
Timepoint [10] 439954 0
First visit 1 day after the block is applied (intervention group) or at the first check-up where it is determined that the patients in the control group have responded to pregabalin treatment and the dose is fixed (control group) At the end of the 3rd month post-baseline
Secondary outcome [11] 439955 0
Change in CD56 Dim levels This is an additional primary outcome
Timepoint [11] 439955 0
First visit 1 day after the block is applied (intervention group) or at the first check-up where it is determined that the patients in the control group have responded to pregabalin treatment and the dose is fixed (control group) At the end of the 3rd month post-baseline
Secondary outcome [12] 439956 0
Change in IFGN levels This is an additional primary outcome
Timepoint [12] 439956 0
First visit 1 day after the block is applied (intervention group) or at the first check-up where it is determined that the patients in the control group have responded to pregabalin treatment and the dose is fixed (control group) At the end of the 3rd month post-baseline
Secondary outcome [13] 439957 0
Change in IL 17A levels This is an additional primary outcome
Timepoint [13] 439957 0
First visit 1 day after the block is applied (intervention group) or at the first check-up where it is determined that the patients in the control group have responded to pregabalin treatment and the dose is fixed (control group) At the end of the 3rd month post-baseline

Eligibility
Key inclusion criteria
Volunteers aged between 18 and 80 years, who have passed the acute phase of the disease, whose vesicles have dried, whose antiviral treatment has been completed, who have involvement of thoracic region dermatomes, who have a DN4 score over 4, who have not started neuropathic pain treatment, and who have been diagnosed with herpes zoster whose pain has not become chronic will be included in the study.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with diabetes mellitus, another disease that may cause neuropathic pain, malignancy, previous treatment for neuropathic pain, bacterial infection in the affected dermatome, autoimmune disease, drug and alcohol addiction, smoking, chronic renal failure and liver failure, immunodeficiency, those who do not agree to participate in the study, and those who are pregnant or breastfeeding will be excluded from the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 26504 0
Turkey
State/province [1] 26504 0

Funding & Sponsors
Funding source category [1] 317175 0
University
Name [1] 317175 0
Necmettin Erbakan University
Country [1] 317175 0
Turkey
Primary sponsor type
University
Name
Necmettin Erbakan University
Address
Country
Turkey
Secondary sponsor category [1] 319438 0
Government body
Name [1] 319438 0
TÜBITAK Turkey Scientific and Technical Research Council
Address [1] 319438 0
Country [1] 319438 0
Turkey

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315919 0
Turkey Pharmaceuticals and Medical Devices Agency
Ethics committee address [1] 315919 0
Ethics committee country [1] 315919 0
Turkey
Date submitted for ethics approval [1] 315919 0
13/10/2021
Approval date [1] 315919 0
17/11/2021
Ethics approval number [1] 315919 0
E-66175679-514.04.01-596461

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 136214 0
Dr Gülçin Büyükbezirci
Address 136214 0
Necmettin Erbakan University Meram Medical Faculty Hocacihan Neighborhood Abdülhamid Han Street Number:3 Post Code:42080 Selçuklu Konya
Country 136214 0
Turkey
Phone 136214 0
+905054455498
Fax 136214 0
Email 136214 0
[email protected]
Contact person for public queries
Name 136215 0
Gülçin Büyükbezirci
Address 136215 0
Necmettin Erbakan University Meram Medical Faculty Hocacihan Neighborhood Abdülhamid Han Street Number:3 Post Code:42080 Selçuklu Konya
Country 136215 0
Turkey
Phone 136215 0
+905054455498
Fax 136215 0
Email 136215 0
[email protected]
Contact person for scientific queries
Name 136216 0
Gülçin Büyükbezirci
Address 136216 0
Necmettin Erbakan University Meram Medical Faculty Hocacihan Neighborhood Abdülhamid Han Street Number:3 Post Code:42080 Selçuklu Konya
Country 136216 0
Turkey
Phone 136216 0
+905054455498
Fax 136216 0
Email 136216 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Only researchers

Conditions for requesting access:
• -

What individual participant data might be shared?
• Individual participant data underlying published results only

What types of analyses could be done with individual participant data?
• Only to achieve the aims in the approved proposal

When can requests for individual participant data be made (start and end dates)?
From:
Following publication no end date determined

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• Access subject to approvals by Principal Investigator by emailing the Principal Investigator ([email protected])

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.