An interventional study of Stellate ganglion block and Sham Stellate ganglion block in Pain and Neuropathic, sponsored by Tanta University. Completed at 3 sites in Egypt. Open to participants aged 60 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-02-13.
Sponsored by Tanta University · Not applicable, Interventional, and Supportive care
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.
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:
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
Equipment
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.
360 studies on the registry are indexed under Herpes Zoster; 60 are open to participants now.
This study's enrollment of 208 is below the median of 250 across 299 interventional studies indexed under Herpes Zoster.
Browse Herpes Zoster studies →Tanta University is the lead sponsor of 963 studies on the registry; 304 are open to participants now.
Of its 16 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Patients will receive sham stellate ganglion block weekly for three times
Procedure: Sham Stellate ganglion block
Patients will receive stellate ganglion block weekly for three times with injection of 6ml bupivicain 0.25%+ 1 ml methylpredinosolone 40mg
Procedure: Stellate ganglion block
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
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
Incidence of Post-herpetic neuralgia
The incidence of chronic neuropathic pain in the face or the neck after herpes zoster
Time frame: within 3 months of the last stellate ganglion block
The duration of herpes zoster
The time from diagnosis of HZ till resolving of it
Time frame: Through study completion, an average of 1 year
Plan to share: No — Once the study had been successfully completed, the data will be shared for other researchers.
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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