PainNCT04188327
Stellate Ganglion Block in Herpes Zoster
A study testing Stellate ganglion block in people with Pain and Neuropathic, run by Tanta University at 3 sites in Egypt.
Trial summary
Patient who will be presented to Tanta University Hospitals complaining of acute herpes zoster with onset of vesicular eruption less than 7 days will be included in this clinical study. Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Pain, Neuropathic
- What is being tested?
- Stellate ganglion block
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 208 participants
- Where
- 3 sitesEgypt
- Study dates
- 1 May 2020to 2 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 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who is presented to the pain clinic, diagnosed with acute herpes zoster of the face and/ or neck with onset of vesicular eruption less than seven days
Who cannot join
- Patient refusal or un-cooperation
- Known history of allergy to local anesthetics
- Local infection at the site of the block
- Platelet count less than 75,000/ cc
- Neurological deficit in the upper limb
- Glaucoma
- Bradycardia
Trial locations and contacts
3 sites in 1 country.
Egypt3 sites
Faculty of Medicine
Al Fayyum, 63512
Faculty of Medicine
Tanta, Algharbia, 31511
Tanta University hospitals
Tanta, 31511
About this study
Official title: Utility of Early Serial Stellate Ganglion Block in Acute Herpes Zoster of Face and Neck
Patient who will be presented to Tanta University Hospitals complaining of acute herpes zoster with onset of vesicular eruption less than 7 days will be included in this clinical study.
Patients will be excluded if they refused participation, had allergy to local anesthetics, coagulopathy, local infection, glaucoma, or neurological deficit.
Read more
All the patients will receive acyclovir (antiviral therapy) and pregablin (analgesic) and the patients will be classified into two groups:- Group I (control group): Patients will receive sham block weekly for three times Group III (SGB group): Patients will receive stellate ganglion block weekly for three times
The time of first block after the onset of vesicular eruption, the incidence of PHN, NPRS at visit, duration of acute HZ , duration of PHN (if occurred), and the incidence of complication will be measured.
Read the detailed description
This prospective randomized study will be carried out on adult patients complaining of acute herpes zoster presented at Tanta University Hospitals after approval from ethics committee for twelve months.
An informed consent will be taken from each patient. All data of patients will be confidential with secret codes and private file for each patient. All given data will be used for the current medical research only.
Any unexpected risk encountered during the course of the research will be cleared to the participant as well as to the Ethical Committee on time. Every patient will receive an explanation to the purpose of the study and will have a secret code number to ensure privacy of the participants and confidentiality of their data.
The study will be terminated in case of incidence of severe hypotension no responding to ephedrine (Mean arterial blood pressure less than 60 mmHg) or severe bradycardia not responding to atropine (Heart rate less than 40 b/min). The participants and the ethical committee will be announced.
There will be adequate supervision to maintain the privacy of patients and confidentiality of data. There will be no conflict of interest, nor conflict with religion, law, or society standards. The research will be beneficial to the society and has no risk of environmental pollution.
After inclusion, adequate history taking, clinical examination, and laboratory investigation (as needed) will be done for all patients. Every patient will be educated about the use of the 0-10 numerical rating scale for pain assessment (NPRS: with endpoints of 'no pain' and 'worst pain').
Each patient will receive:
- Acyclovir 800 mg orally every 5 times per day (for immuno-compromised patients 10 mg/kg IV 3 times per day) for 7 days.
- Pregabalin start with 50 mg orally every 8hours for 7 days then increase to 150 mg every 12 hours
Groups:
Participants will be divided into two groups; each group consists of (88) patients. The sample size calculation was made using Epi-Info software program created by the WHO
- Group I (control group): Patients will receive sham block weekly for three times
- Group II (SGB group): Patients will receive stellate ganglion block weekly for three times
Equipment
- 10-mL syringe - For local anesthetic
- 22- or 25-gauge, 1.5-inch short-bevel needle
- Skin temperature monitor
- Ultrasound machine with a 6-12 MHz linear type probe.
- Appropriate equipment and medications for medical resuscitation
Technique of SGB:
The patient will be positioned supine with slight neck extension and rotation to the contralateral side. After adequate asepsis of the neck, the probe will be placed perpendicular to tracheal axis at the cricoid cartilage. An initial scan will be obtained to identify structures: thyroid gland, carotid artery and jugular vein.
The transverse process at C6 should be identified as the initial landmark because of its prominent anterior tubercle (The Chassaignac tubercle). The long muscle of the neck (longus colli) is found above it.
The puncture should be in-plane to see the tip of the needle all the time. The needle will be directed medially until it passes through the deep cervical fascia above the longus colli muscle.
Considering repeated aspiration test, a 7 ml injectate (for SGB group: 6ml bupivicain 0.25%+ 1 ml methylpredinosolone 40mg) will be done while observing the dissection between the carotid artery and the longus colli muscle.
After finishing the block:
The patient will be transferred to the recovery room for 30-60 min to assess any potential complications. After that he will be discharged.
Review appointments will be arranged weekly for 4 weeks then every 2 weeks for 4 months.
- Conditions
- Pain, Neuropathic
- Being tested
- Stellate ganglion block, Sham Stellate ganglion block
- Keywords
- Herpes Zoster, Stellate ganglion, Post-herpetic neuralgia
- Medical subject headings
- Pain, Herpes Zoster, Neuralgia, Postherpetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stellate ganglion blockProcedure or surgery
While the patient is in a supine position with slight neck extension and rotation to the contralateral side, in-plane ultrasound guided stellate ganglion block will be performed with injection of 7 ml injectate (6ml bupivicain 0.25%+ 1 ml methylpredinosolone 40mg).
Each patient will receive:
- Acyclovir 800 mg orally every 5 times per day 7 days.
- Pregabalin start with 50 mg orally every 8hours for 7 days then increase to 150 mg every 12 hours
Sham Stellate ganglion blockProcedure or surgery
The patient will be positioned supine with slight neck extension and rotation to the contralateral side. Under US guidance, a sham stellate ganglion block will be performed with injection of a 1ml injectate of normal saline will be done while observing the dissection between the carotid artery and the longus colli muscle.
Each patient will receive:
- Acyclovir 800 mg orally every 5 times per day for 7 days.
- Pregabalin start with 50 mg orally every 8hours for 7 days then increase to 150 mg every 12 hours
| Study group | Role | What they receive |
|---|---|---|
| Control group(Group I) | Sham comparator | Patients will receive sham stellate ganglion block weekly for three times Receives: Procedure: Sham Stellate ganglion block |
| Stellate Ganglion block group (Group II) | Experimental | Patients will receive stellate ganglion block weekly for three times with injection of 6ml bupivicain 0.25%+ 1 ml methylpredinosolone 40mg Receives: Procedure: Stellate ganglion block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Post-herpetic neuralgia
The incidence of chronic neuropathic pain in the face or the neck after herpes zoster
Measured: within 3 months of the last stellate ganglion block
Secondary outcomes (1)
The duration of herpes zoster
The time from diagnosis of HZ till resolving of it
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2019
- Study start1 May 2020
- Primary completion2 Feb 2025
- Study completion2 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Model description
- Prospective randomized controlled study
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Collaborators
- Mohamad Gamal Elmawy, M.D
- Responsible party
- Principal investigator, Sameh Abdelkhalik Ahmed Ismaiel, Tanta University
- Investigators
- Sameh Ismaiel, M.D, Principal investigator, Lecturer of Anesthesia and Intensive Care, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04188327
- Sponsor's protocol ID
- 33426/10/10
- Status last verified
- Feb 2025
- First submitted
- 28 Nov 2019
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Once the study had been successfully completed, the data will be shared for other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of Early Serial Stellate Ganglion Block in Acute Herpes Zoster of Face and Neck
- ClinicalTrials.gov ID
- NCT04188327
- Acronym / sponsor ID
- 33426/10/10
- Conditions
- Pain, Neuropathic
- Keywords
- Herpes Zoster, Stellate ganglion, Post-herpetic neuralgia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Collaborators
- Mohamad Gamal Elmawy, M.D
- Study start
- 1 May 2020 (actual)
- Primary completion
- 2 Feb 2025 (actual)
- Study completion
- 2 Feb 2025 (actual)
- First posted
- 5 Dec 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.
Patient who will be presented to Tanta University Hospitals complaining of acute herpes zoster with onset of vesicular eruption less than 7 days will be included in this clinical study.
Patients will be excluded if they refused participation, had allergy to local anesthetics, coagulopathy, local infection, glaucoma, or neurological deficit.
All the patients will receive acyclovir (antiviral therapy) and pregablin (analgesic) and the patients will be classified into two groups:- Group I (control group): Patients will receive sham block weekly for three times Group III (SGB group): Patients will receive stellate ganglion block weekly for three times
The time of first block after the onset of vesicular eruption, the incidence of PHN, NPRS at visit, duration of acute HZ , duration of PHN (if occurred), and the incidence of complication will be measured.
Detailed description
This prospective randomized study will be carried out on adult patients complaining of acute herpes zoster presented at Tanta University Hospitals after approval from ethics committee for twelve months.
An informed consent will be taken from each patient. All data of patients will be confidential with secret codes and private file for each patient. All given data will be used for the current medical research only.
Any unexpected risk encountered during the course of the research will be cleared to the participant as well as to the Ethical Committee on time. Every patient will receive an explanation to the purpose of the study and will have a secret code number to ensure privacy of the participants and confidentiality of their data.
The study will be terminated in case of incidence of severe hypotension no responding to ephedrine (Mean arterial blood pressure less than 60 mmHg) or severe bradycardia not responding to atropine (Heart rate less than 40 b/min). The participants and the ethical committee will be announced.
There will be adequate supervision to maintain the privacy of patients and confidentiality of data. There will be no conflict of interest, nor conflict with religion, law, or society standards. The research will be beneficial to the society and has no risk of environmental pollution.
After inclusion, adequate history taking, clinical examination, and laboratory investigation (as needed) will be done for all patients. Every patient will be educated about the use of the 0-10 numerical rating scale for pain assessment (NPRS: with endpoints of 'no pain' and 'worst pain').
Each patient will receive:
- Acyclovir 800 mg orally every 5 times per day (for immuno-compromised patients 10 mg/kg IV 3 times per day) for 7 days.
- Pregabalin start with 50 mg orally every 8hours for 7 days then increase to 150 mg every 12 hours
Groups:
Participants will be divided into two groups; each group consists of (88) patients. The sample size calculation was made using Epi-Info software program created by the WHO
- Group I (control group): Patients will receive sham block weekly for three times
- Group II (SGB group): Patients will receive stellate ganglion block weekly for three times
Equipment
- 10-mL syringe - For local anesthetic
- 22- or 25-gauge, 1.5-inch short-bevel needle
- Skin temperature monitor
- Ultrasound machine with a 6-12 MHz linear type probe.
- Appropriate equipment and medications for medical resuscitation
Technique of SGB:
The patient will be positioned supine with slight neck extension and rotation to the contralateral side. After adequate asepsis of the neck, the probe will be placed perpendicular to tracheal axis at the cricoid cartilage. An initial scan will be obtained to identify structures: thyroid gland, carotid artery and jugular vein.
The transverse process at C6 should be identified as the initial landmark because of its prominent anterior tubercle (The Chassaignac tubercle). The long muscle of the neck (longus colli) is found above it.
The puncture should be in-plane to see the tip of the needle all the time. The needle will be directed medially until it passes through the deep cervical fascia above the longus colli muscle.
Considering repeated aspiration test, a 7 ml injectate (for SGB group: 6ml bupivicain 0.25%+ 1 ml methylpredinosolone 40mg) will be done while observing the dissection between the carotid artery and the longus colli muscle.
After finishing the block:
The patient will be transferred to the recovery room for 30-60 min to assess any potential complications. After that he will be discharged.
Review appointments will be arranged weekly for 4 weeks then every 2 weeks for 4 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| Control group(Group I) | Sham comparator | Procedure: Sham Stellate ganglion blockPatients will receive sham stellate ganglion block weekly for three times |
| Stellate Ganglion block group (Group II) | Experimental | Procedure: Stellate ganglion blockPatients will receive stellate ganglion block weekly for three times with injection of 6ml bupivicain 0.25%+ 1 ml methylpredinosolone 40mg |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who is presented to the pain clinic, diagnosed with acute herpes zoster of the face and/ or neck with onset of vesicular eruption less than seven days
Key exclusion criteria (7 listed)
- Patient refusal or un-cooperation
- Known history of allergy to local anesthetics
- Local infection at the site of the block
- Platelet count less than 75,000/ cc
- Neurological deficit in the upper limb
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 |
|---|---|---|
| Stellate ganglion blockWhile the patient is in a supine position with slight neck extension and rotation to the contralateral side, in-plane ultrasound guided stellate ganglion block will be performed with injection of 7 ml injectate (6ml bupivicain 0.25%+ 1 ml methylpredinosolone 40mg). Each patient will receive: * Acyclovir 800 mg orally every 5 times per day 7 days. * Pregabalin start with 50 mg orally every 8hours for 7 days then increase to 150 mg every 12 hours | Procedure or surgery | Stellate Ganglion block group (Group II) |
| Sham Stellate ganglion blockThe patient will be positioned supine with slight neck extension and rotation to the contralateral side. Under US guidance, a sham stellate ganglion block will be performed with injection of a 1ml injectate of normal saline will be done while observing the dissection between the carotid artery and the longus colli muscle. Each patient will receive: * Acyclovir 800 mg orally every 5 times per day for 7 days. * Pregabalin start with 50 mg orally every 8hours for 7 days then increase to 150 mg every 12 hours | Procedure or surgery | Control group(Group I) |
Primary outcome
Incidence of Post-herpetic neuralgia
Time frame: within 3 months of the last stellate ganglion block
The incidence of chronic neuropathic pain in the face or the neck after herpes zoster
1 secondary outcome
The duration of herpes zoster
Time frame: Through study completion, an average of 1 year
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 13 Feb 2025.
- Individual participant dataSharing planned: No. Once the study had been successfully completed, the data will be shared for other researchers.
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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.
Sameh Ismaiel, M.D principal investigator
Lecturer of Anesthesia and Intensive Care, Tanta University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stellate ganglion block in people with Pain and Neuropathic, run by Tanta University at 3 sites 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 7 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 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. 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.
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?
Incidence of Post-herpetic neuralgia (time frame: within 3 months of the last stellate ganglion block). 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 13 Feb 2025.