Stellate Ganglion Block in Herpes Zoster

NCT ID: NCT04188327

Last Updated: 2025-02-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 208 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-01
• Study Completion Date: 2025-02-02

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Control group(Group I)

Patients will receive sham stellate ganglion block weekly for three times

Group Type: SHAM_COMPARATOR

Sham Stellate ganglion block

Intervention Type: 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

Stellate Ganglion block group (Group II)

Patients will receive stellate ganglion block weekly for three times with injection of 6ml bupivicain 0.25%+ 1 ml methylpredinosolone 40mg

Group Type: EXPERIMENTAL

Stellate ganglion block

Intervention Type: 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

Interventions

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

Intervention Type: PROCEDURE

Sham Stellate ganglion block

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mohamad Gamal Elmawy, M.D

UNKNOWN

Sponsor Role: collaborator

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Sameh Abdelkhalik Ahmed Ismaiel

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sameh Ismaiel, M.D

Role: PRINCIPAL_INVESTIGATOR

Lecturer of Anesthesia and Intensive Care, Tanta University

Locations

Faculty of Medicine

Tanta, Algharbia, Egypt

Faculty of Medicine

Al Fayyum, , Egypt

Tanta University hospitals

Tanta, , Egypt

Countries

Egypt

Other Identifiers

33426/10/10

Identifier Type: -

Identifier Source: org_study_id