Stellate Ganglion Block in Herpes Zoster

NCT04188327 | Completed

• 1 other identifier: 33426/10/10
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 3

Brief 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. 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.

Conditions

Pain; Neuropathic

Keywords

Herpes Zoster; Stellate ganglion; Post-herpetic neuralgia

Outcome Measures

Primary Outcomes (1)

• Incidence of Post-herpetic neuralgia

  The incidence of chronic neuropathic pain in the face or the neck after herpes zoster

  within 3 months of the last stellate ganglion block

Secondary Outcomes (1)

• The duration of herpes zoster

  Through study completion, an average of 1 year

Study Arms (2)

Control group(Group I)

SHAM COMPARATOR

Patients will receive sham stellate ganglion block weekly for three times

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

Procedure: Stellate ganglion block

Interventions

Stellate ganglion block PROCEDURE

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

Stellate Ganglion block group (Group II)

Sham Stellate ganglion block PROCEDURE

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

Control group(Group I)

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tanta University: lead
• Mohamad Gamal Elmawy, M.D: collaborator

Study Sites (3)

Faculty of Medicine

Tanta, Algharbia, 31511, Egypt

Location

Faculty of Medicine

Al Fayyum, 63512, Egypt

Location

Tanta University hospitals

Tanta, 31511, Egypt

Location

MeSH Terms

Conditions

Pain; Herpes Zoster; Neuralgia, Postherpetic

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Neuralgia; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Sameh Ismaiel, M.D

  Lecturer of Anesthesia and Intensive Care, Tanta University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: * The patients will be blind through the use of closed sealed envelops. * The investigator will be blind through the use of sham block in the control group. * The measurement will be collected by anesthesiologist not participating in the study and blinded to its group
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Model Details: Prospective randomized controlled study

Study Record Dates

• First Submitted: November 28, 2019
• First Posted: December 5, 2019
• Study Start: May 1, 2020
• Primary Completion: February 2, 2025
• Study Completion: February 2, 2025
• Last Updated: February 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (3)