Acute Herpes Zoster Pain ManagmentNCT06307444
Ultrasound-Guided Erectro Spinae Plane Block Versus Stellate Ganglion Block for Patients With Upper Limb Acute Herpes Zoster Pain.
A study testing Ultrasound-Guided Stellate Ganglion Block and T2 T3 (High Thorathic) ESP Block in people with Acute Herpes Zoster Pain Managment, run by Tanta University at 1 site in Egypt.
Trial summary
Herpes zoster (HZ) is a painful, eruptive, viral condition results from reactivation of the latent varicella zoster virus after the primary infection. The selection of an effective analgesic method in the acute phase of herpes zoster can decrease the incidence of postherpetic neuralgia by reducing neural… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Acute Herpes Zoster Pain Managment
- What is being tested?
- Ultrasound-Guided Stellate Ganglion Block and T2 T3 (High Thorathic) ESP Block
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Mar 2024to 1 Feb 2025
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients over the age of 21 with upper limb herpetic eruption lasting shorter than a week along with moderate to severe pain who got adequate antiviral medications
Who cannot join
- We will exclude patients who refuse to participate, those who are taking anticoagulant medications, have secondary bacterial infections of the dermatome, those who have an allergy to local anesthetics or serious disease of the heart ( e.g. heart block), lung, kidneys and those who had a history of neck surgery, such as thyroid cancer.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound-Guided Erectro Spinae Plane Block Versus Stellate Ganglion Block for Patients With Upper Limb Acute Herpes Zoster Pain: Randomized Controlled Study
Herpes zoster (HZ) is a painful, eruptive, viral condition results from reactivation of the latent varicella zoster virus after the primary infection. The selection of an effective analgesic method in the acute phase of herpes zoster can decrease the incidence of postherpetic neuralgia by reducing neural sensitization. The stellate ganglion is present in 80% of the general population and is composed of the inferior cervical ganglion and the first thoracic ganglion fusion. It lies anterior to the neck of the first rib and extends to the inferior aspect of the transverse process of C7. The erector spinae plane (ESP) block has been reported to provide diffuse and effective analgesia in the cervical, thoracic, and lumbar regions.
Read the detailed description
Especially for elderly patients, when cell-mediated immunity wanes, common symptoms of HZ appear, primarily as pain in a dermatomal distribution with a burning, sharp pain sensation (paresthesia) and itching, in addition to development of a vesicular rash. The selection of an effective analgesic method in the acute phase of herpes zoster can decrease the incidence of postherpetic neuralgia by reducing neural sensitization. The sympathetic fibers for the head, neck, heart, and upper limbs arise from the first thoracic segments, ascend through the sympathetic chain, and synapse in the superior, middle, and inferior cervical ganglions. The stellate ganglion is present in 80% of the general population and is composed of the inferior cervical ganglion and the first thoracic ganglion fusion. It lies anterior to the neck of the first rib and extends to the inferior aspect of the transverse process of C7. The erector spinae plane (ESP) block has been reported to provide diffuse and effective analgesia in the cervical, thoracic, and lumbar regions.
- Conditions
- Acute Herpes Zoster Pain Managment
- Being tested
- Ultrasound-Guided Stellate Ganglion Block, T2 T3 (High Thorathic) ESP Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-Guided Stellate Ganglion BlockProcedure or surgery
high frequency (6 to 13 MHz) linear transducer will be placed perpendicular to the tracheal axis at the cricoid cartilage and will be moved inferiorly until the superior aspect of the thyroid gland is visualized. Later, the transducer should be relocated laterally to visualize the anterior aspect of the Chassaignac's tubercle on []the C6 transverse process. The carotid artery, internal jugular vein, thyroid gland, trachea, Longus colli, and Longus capitis muscle, prevertebral fascia, the root of C6 spinal nerve, and transverse process of C6 can be identified. Color Doppler will be used to detect the position of the vessels. With an in-plane approach, 22 to 25 gauge echo-enhanced needle is placed beside the trachea with a lateral to medial direction.
T2 T3 (High Thorathic) ESP BlockProcedure or surgery
We will count the laminae in the cephaled-to-caudal direction, starting from the C7 using the US to determine the exact vertebral level where the needle will be inserted. A linear high-frequency ultrasound probe will be used to perform the blocks. After the determination of the needle insertion site, the US probe was placed over the spinous processes of the vertebrae at the midline in the longitudinal plane. The US probe will then slid laterally from the spinous processes to visualize the transverse process. The needle will be advanced posterior-to-anteriorly, in the caudal to cephalic direction using the in-plane orientation within paraspinal muscles, targeting the transverse process. When the tip of the needle reaches and contact the transverse process, the local anesthetic drugs(0.2-0.3ml/kg(11) of bupivacaine 0.25% 8mg Dexamethazone) will be administered
| Study group | Role | What they receive |
|---|---|---|
| medical treatment only | No intervention | All patients will receive oral medication for antiviral therapy (800mg of acyclovir 5 times daily) at the time of diagnosis and supportive treatments, including acetaminophen (1gm 3times daily), and gabapentin (starting at 100mg three times daily) to be incrementally up titrated over time as needed by 100 to 300 mg every 3 to 5 days, to as high a dosage as 1800 to 3600 mg/day in 3 or 4 divided doses |
| Ultrasound-Guided Stellate Ganglion Block | Experimental | Ten milliliters of a local anesthetic solution (bupivacaine (0.25%)+ 8 mg dexamethasone) is injected until the fluid spreads along the paravertebral fascia to the stellate ganglion. Receives: Procedure: Ultrasound-Guided Stellate Ganglion Block |
| Group III T2 T3 (High Thorathic) ErectroSpinae Plan Block | Experimental | ocal anesthetic drugs(0.2-0.3ml/kg of bupivacaine 0.25% 8mg Dexamethazone) will be administered as standard in all patients aiming to distribute within the plane between the anterior fascia of the erector spinae muscle and the transverse process. Receives: Procedure: T2 T3 (High Thorathic) ESP Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
reduction of a numeric rating scale (NRS) pain score
- Pain intensity before block by NRS score (0-10)
- Pain intensity after block by NRS score (0-10) Pain intensity at 1,2,3,4, ,6,8,12 and24 weeks
Measured: after the porcedure till 12 weak
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start20 Mar 2024
- Primary completion1 Dec 2024
- Study completion1 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Herpes Zoster Pain ManagmentStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aliaa Muhammad Belal, Tanta University
- Investigators
- Aliaa M Belal, MD, Principal investigator, tanta univ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06307444
- Sponsor's protocol ID
- stellate block and ESP block
- Status last verified
- Apr 2025
- First submitted
- 6 Mar 2024
- Last updated
- 29 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-Guided Erectro Spinae Plane Block Versus Stellate Ganglion Block for Patients With Upper Limb Acute Herpes Zoster Pain: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06307444
- Acronym / sponsor ID
- stellate block and ESP block
- Conditions
- Acute Herpes Zoster Pain Managment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 20 Mar 2024 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Feb 2025 (actual)
- First posted
- 12 Mar 2024 (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.
Herpes zoster (HZ) is a painful, eruptive, viral condition results from reactivation of the latent varicella zoster virus after the primary infection. The selection of an effective analgesic method in the acute phase of herpes zoster can decrease the incidence of postherpetic neuralgia by reducing neural sensitization. The stellate ganglion is present in 80% of the general population and is composed of the inferior cervical ganglion and the first thoracic ganglion fusion. It lies anterior to the neck of the first rib and extends to the inferior aspect of the transverse process of C7. The erector spinae plane (ESP) block has been reported to provide diffuse and effective analgesia in the cervical, thoracic, and lumbar regions.
Detailed description
Especially for elderly patients, when cell-mediated immunity wanes, common symptoms of HZ appear, primarily as pain in a dermatomal distribution with a burning, sharp pain sensation (paresthesia) and itching, in addition to development of a vesicular rash. The selection of an effective analgesic method in the acute phase of herpes zoster can decrease the incidence of postherpetic neuralgia by reducing neural sensitization. The sympathetic fibers for the head, neck, heart, and upper limbs arise from the first thoracic segments, ascend through the sympathetic chain, and synapse in the superior, middle, and inferior cervical ganglions. The stellate ganglion is present in 80% of the general population and is composed of the inferior cervical ganglion and the first thoracic ganglion fusion. It lies anterior to the neck of the first rib and extends to the inferior aspect of the transverse process of C7. The erector spinae plane (ESP) block has been reported to provide diffuse and effective analgesia in the cervical, thoracic, and lumbar regions.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| medical treatment only | No intervention | –All patients will receive oral medication for antiviral therapy (800mg of acyclovir 5 times daily) at the time of diagnosis and supportive treatments, including acetaminophen (1gm 3times daily), and gabapentin (starting at 100mg three times daily) to be incrementally up titrated over time as needed by 100 to 300 mg every 3 to 5 days, to as high a dosage as 1800 to 3600 mg/day in 3 or 4 divided doses |
| Ultrasound-Guided Stellate Ganglion Block | Experimental | Procedure: Ultrasound-Guided Stellate Ganglion BlockTen milliliters of a local anesthetic solution (bupivacaine (0.25%)+ 8 mg dexamethasone) is injected until the fluid spreads along the paravertebral fascia to the stellate ganglion. |
| Group III T2 T3 (High Thorathic) ErectroSpinae Plan Block | Experimental | Procedure: T2 T3 (High Thorathic) ESP Blockocal anesthetic drugs(0.2-0.3ml/kg of bupivacaine 0.25% 8mg Dexamethazone) will be administered as standard in all patients aiming to distribute within the plane between the anterior fascia of the erector spinae muscle and the transverse process. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients over the age of 21 with upper limb herpetic eruption lasting shorter than a week along with moderate to severe pain who got adequate antiviral medications
Key exclusion criteria (1 listed)
- We will exclude patients who refuse to participate, those who are taking anticoagulant medications, have secondary bacterial infections of the dermatome, those who have an allergy to local anesthetics or serious disease of the heart ( e.g. heart block), lung, kidneys and those who had a history of neck surgery, such as thyroid cancer.
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 |
|---|---|---|
| Ultrasound-Guided Stellate Ganglion Blockhigh frequency (6 to 13 MHz) linear transducer will be placed perpendicular to the tracheal axis at the cricoid cartilage and will be moved inferiorly until the superior aspect of the thyroid gland is visualized. Later, the transducer should be relocated laterally to visualize the anterior aspect of the Chassaignac's tubercle on []the C6 transverse process. The carotid artery, internal jugular vein, thyroid gland, trachea, Longus colli, and Longus capitis muscle, prevertebral fascia, the root of C6 spinal nerve, and transverse process of C6 can be identified. Color Doppler will be used to detect the position of the vessels. With an in-plane approach, 22 to 25 gauge echo-enhanced needle is placed beside the trachea with a lateral to medial direction. | Procedure or surgery | Ultrasound-Guided Stellate Ganglion Block |
| T2 T3 (High Thorathic) ESP BlockWe will count the laminae in the cephaled-to-caudal direction, starting from the C7 using the US to determine the exact vertebral level where the needle will be inserted. A linear high-frequency ultrasound probe will be used to perform the blocks. After the determination of the needle insertion site, the US probe was placed over the spinous processes of the vertebrae at the midline in the longitudinal plane. The US probe will then slid laterally from the spinous processes to visualize the transverse process. The needle will be advanced posterior-to-anteriorly, in the caudal to cephalic direction using the in-plane orientation within paraspinal muscles, targeting the transverse process. When the tip of the needle reaches and contact the transverse process, the local anesthetic drugs(0.2-0.3ml/kg(11) of bupivacaine 0.25% 8mg Dexamethazone) will be administered | Procedure or surgery | Group III T2 T3 (High Thorathic) ErectroSpinae Plan Block |
Primary outcome
reduction of a numeric rating scale (NRS) pain score
Time frame: after the porcedure till 12 weak
1. Pain intensity before block by NRS score (0-10) 2. Pain intensity after block by NRS score (0-10) Pain intensity at 1,2,3,4, ,6,8,12 and24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2025.
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.
Aliaa M Belal, MD principal investigator
tanta univ
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-Guided Stellate Ganglion Block and T2 T3 (High Thorathic) ESP Block in people with Acute Herpes Zoster Pain Managment, run by Tanta University at 1 site in Egypt.
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 1 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: finished, as of the sponsor's last update on 29 Apr 2025. 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 Egypt. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
reduction of a numeric rating scale (NRS) pain score (time frame: after the porcedure till 12 weak). 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 29 Apr 2025.