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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
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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
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Secondary ID [1]
312742
0
None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Pain management
334776
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Herpes zoster
334959
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Postherpetic neuralgia
334960
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Condition category
Condition code
Infection
331336
331336
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0
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Other infectious diseases
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Inflammatory and Immune System
331337
331337
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0
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Normal development and function of the immune system
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Anaesthesiology
331489
331489
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0
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Pain management
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
329273
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Treatment: Drugs
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
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Change in CD3 levels
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Assessment method [1]
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CD3 levels will be studied in the blood samples taken.
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Timepoint [1]
339098
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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
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Primary outcome [2]
339231
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Rate of development of postherpetic neuralgia
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Assessment method [2]
339231
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Numeric Rating Scale Score
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Timepoint [2]
339231
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At the end of the 3 months
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Primary outcome [3]
339429
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Change in CD4 levels
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Assessment method [3]
339429
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CD4 levels will be studied in the blood samples taken.
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Timepoint [3]
339429
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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
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Secondary outcome [1]
438548
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Change in pain levels
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Assessment method [1]
438548
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Numering Rating Scale (NRS) Scores
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Timepoint [1]
438548
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Baseline and two weeks post-baseline
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Secondary outcome [2]
439179
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Change in effect of pain on sleep quality
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Assessment method [2]
439179
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Sleep Interferance Score (SIS)
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Timepoint [2]
439179
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Baseline and two weeks post-baseline
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Secondary outcome [3]
439180
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Change in neuropathic pain
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Assessment method [3]
439180
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Douleur Neuropathique 4 (DN4) Score
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Timepoint [3]
439180
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Baseline and two weeks post-baseline
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Secondary outcome [4]
439948
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Change in CD8 levels
This is an additional primary outcome
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Assessment method [4]
439948
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CD8 levels will be studied in the blood samples taken.
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Timepoint [4]
439948
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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
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Secondary outcome [5]
439949
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Change in FOX3 levels
This is an additional primary outcome
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Assessment method [5]
439949
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FOX3 levels will be studied in the blood samples taken.
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Timepoint [5]
439949
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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
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Secondary outcome [6]
439950
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Change in Defective T levels
This is an additional primary outcome
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Assessment method [6]
439950
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Defective T levels will be studied in the blood samples taken.
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Timepoint [6]
439950
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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
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Secondary outcome [7]
439951
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Change in Regulatory T levels
This is an additional primary outcome
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Assessment method [7]
439951
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Regulatory T levels will be studied in the blood samples taken.
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Timepoint [7]
439951
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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
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Secondary outcome [8]
439952
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Change in Cytotoxic T levels
This is an additional primary outcome
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Assessment method [8]
439952
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Cytotoxic T levels will be studied in the blood samples taken.
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Timepoint [8]
439952
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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
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Secondary outcome [9]
439953
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Change in CD57 levels
This is an additional primary outcome
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Assessment method [9]
439953
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CD57 levels will be studied in the blood samples taken.
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Timepoint [9]
439953
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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
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Secondary outcome [10]
439954
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Change in CD56 Bright levels
This is an additional primary outcome
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Assessment method [10]
439954
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CD56 Bright levels will be studied in the blood samples taken.
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Timepoint [10]
439954
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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
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Secondary outcome [11]
439955
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Change in CD56 Dim levels
This is an additional primary outcome
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Assessment method [11]
439955
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CD56 Dim levels will be studied in the blood samples taken.
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Timepoint [11]
439955
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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
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Secondary outcome [12]
439956
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Change in IFGN levels
This is an additional primary outcome
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Assessment method [12]
439956
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IFGN levels will be studied in the blood samples taken.
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Timepoint [12]
439956
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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
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Secondary outcome [13]
439957
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Change in IL 17A levels
This is an additional primary outcome
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Assessment method [13]
439957
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IL 17A levels will be studied in the blood samples taken.
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Timepoint [13]
439957
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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
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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.
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Minimum age
18
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/10/2024
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
30
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
26504
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Turkey
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State/province [1]
26504
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Funding & Sponsors
Funding source category [1]
317175
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University
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Name [1]
317175
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Necmettin Erbakan University
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Address [1]
317175
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Country [1]
317175
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Turkey
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Primary sponsor type
University
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Name
Necmettin Erbakan University
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Address
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Country
Turkey
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Secondary sponsor category [1]
319438
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Government body
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Name [1]
319438
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TÜBITAK Turkey Scientific and Technical Research Council
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Address [1]
319438
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Country [1]
319438
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Turkey
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
315919
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Turkey Pharmaceuticals and Medical Devices Agency
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Ethics committee address [1]
315919
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Sögütözü Neighbourhood 2176 Street No:5 06520 Çankaya Ankara
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Ethics committee country [1]
315919
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Turkey
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Date submitted for ethics approval [1]
315919
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13/10/2021
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Approval date [1]
315919
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17/11/2021
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Ethics approval number [1]
315919
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E-66175679-514.04.01-596461
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Summary
Brief summary
Many studies have been conducted previously investigating the relationship between neuropathic pain and the immune system. However, no study has been conducted to reveal the effect of erector spinae plane block on immunological markers and the difference between it and pregabalin. Therefore, it was aimed to conduct a study using the most frequently investigated cytokines in the pathogenesis of neuropathic pain with the hypothesis that erector spinae plane block, used as an adjunct in patients who do not respond to pregabalin, may also have an effect on immunological markers that play a role in the development of neuropathic pain.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Gülçin Büyükbezirci
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Address
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Necmettin Erbakan University Meram Medical Faculty Hocacihan Neighborhood Abdülhamid Han Street Number:3 Post Code:42080 Selçuklu Konya
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Country
136214
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Turkey
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Phone
136214
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+905054455498
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Fax
136214
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Email
136214
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[email protected]
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Contact person for public queries
Name
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Gülçin Büyükbezirci
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Address
136215
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Necmettin Erbakan University Meram Medical Faculty Hocacihan Neighborhood Abdülhamid Han Street Number:3 Post Code:42080 Selçuklu Konya
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Country
136215
0
Turkey
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Phone
136215
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+905054455498
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Fax
136215
0
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Email
136215
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[email protected]
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Contact person for scientific queries
Name
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Gülçin Büyükbezirci
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Address
136216
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Necmettin Erbakan University Meram Medical Faculty Hocacihan Neighborhood Abdülhamid Han Street Number:3 Post Code:42080 Selçuklu Konya
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Country
136216
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Turkey
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Phone
136216
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+905054455498
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Fax
136216
0
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Email
136216
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Individual participant data underlying published results only
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When will data be available (start and end dates)?
Following publication no end date determined
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Available to whom?
Only researchers
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Available for what types of analyses?
Only to achieve the aims in the approved proposal
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How or where can data be obtained?
Access subject to approvals by Principal Investigator by emailing the Principal Investigator (
[email protected]
)
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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.
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