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Stellate Ganglion Block in Herpes Zoster

Primary Purpose

Pain, Neuropathic

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Stellate ganglion block
Sham Stellate ganglion block
Sponsored by
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pain focused on measuring Herpes Zoster, Stellate ganglion, Post-herpetic neuralgia

Eligibility Criteria

60 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Faculty of MedicineRecruiting
  • Faculty of MedicineRecruiting
  • Tanta University hospitalsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Control group(Group I)

Stellate Ganglion block group (Group II)

Arm Description

Patients will receive sham stellate ganglion block weekly for three times

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

Outcomes

Primary Outcome Measures

Incidence of Post-herpetic neuralgia
The incidence of chronic neuropathic pain in the face or the neck after herpes zoster

Secondary Outcome Measures

The duration of herpes zoster
The time from diagnosis of HZ till resolving of it

Full Information

First Posted
November 28, 2019
Last Updated
August 11, 2023
Sponsor
Tanta University
Collaborators
Mohamad Gamal Elmawy, M.D
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1. Study Identification

Unique Protocol Identification Number
NCT04188327
Brief Title
Stellate Ganglion Block in Herpes Zoster
Official Title
Utility of Early Serial Stellate Ganglion Block in Acute Herpes Zoster of Face and Neck
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2020 (Actual)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
October 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University
Collaborators
Mohamad Gamal Elmawy, M.D

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Neuropathic
Keywords
Herpes Zoster, Stellate ganglion, Post-herpetic neuralgia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective randomized controlled study
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
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
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group(Group I)
Arm Type
Sham Comparator
Arm Description
Patients will receive sham stellate ganglion block weekly for three times
Arm Title
Stellate Ganglion block group (Group II)
Arm Type
Experimental
Arm Description
Patients will receive stellate ganglion block weekly for three times with injection of 6ml bupivicain 0.25%+ 1 ml methylpredinosolone 40mg
Intervention Type
Procedure
Intervention Name(s)
Stellate ganglion block
Intervention Description
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
Intervention Name(s)
Sham Stellate ganglion block
Intervention Description
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
Primary Outcome Measure Information:
Title
Incidence of Post-herpetic neuralgia
Description
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
Secondary Outcome Measure Information:
Title
The duration of herpes zoster
Description
The time from diagnosis of HZ till resolving of it
Time Frame
Through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sohair Soliman, Professor
Phone
00201283929049
Email
sohairsoliman@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed Aly, M.D
Phone
00201099957971
Email
moh_aly_2005@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sameh Ismaiel, M.D
Organizational Affiliation
Lecturer of Anesthesia and Intensive Care, Tanta University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine
City
Tanta
State/Province
Algharbia
ZIP/Postal Code
31511
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sameh Ismaiel, M.D
Phone
00201002977048
Email
samehabdelkhalik1982@gmail.com
First Name & Middle Initial & Last Name & Degree
Mohamed Abduallah, M.D
Phone
00201099957971
Email
moh_aly_2005@hotmail.com
Facility Name
Faculty of Medicine
City
Fayoum
ZIP/Postal Code
63512
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed Awad, M.D
Phone
00201223881100
First Name & Middle Initial & Last Name & Degree
Mohamed Fouad, M.D
Phone
00201111645345
Facility Name
Tanta University hospitals
City
Tanta
ZIP/Postal Code
31511
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sohair Soliman, Professor
Phone
00201283929049
Email
sohairsoliman@hotmail.com
First Name & Middle Initial & Last Name & Degree
Mohamed Abduallah, M.D
Phone
00201099957971
Email
moh_aly_2005@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Once the study had been successfully completed, the data will be shared for other researchers.

Learn more about this trial

Stellate Ganglion Block in Herpes Zoster

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