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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in Egypt

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 groups in NCT04188327
Study groupRoleWhat they receive
Control group(Group I)Sham comparatorPatients will receive sham stellate ganglion block weekly for three times
Receives: Procedure: Sham Stellate ganglion block
Stellate Ganglion block group (Group II)ExperimentalPatients 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.

  1. 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)
  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.

  1. First posted5 Dec 2019
  2. Study start1 May 2020
  3. Primary completion2 Feb 2025
  4. Study completion2 Feb 2025

Resources

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)
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.

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.

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