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Erector Spinae Block Versus Thoracic Paravertebral Block for Acute Thoracic Herpes Zoster

Primary Purpose

Acute Thoracic Herpes Zoster, Erector Spinae Plane Block, Thoracic Paravertebral Block

Status
Unknown status
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Control Rx
Erector Spinae Block
Thoracic Paravertebral Block
Sponsored by
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Thoracic Herpes Zoster

Eligibility Criteria

51 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Over 50 years of age
  • Chest wall herpetic eruption of less than one week
  • Moderate or severe pain

Exclusion Criteria:

  • Patient refusal
  • Eruption more than one week duration
  • Patients who will not receive appropriate anti-viral therapy
  • Patients with mild pain
  • Infection at the site of injection
  • Patients with a history of renal, hepatic diseases, coagulopathy, steroid therapy, malignancies.
  • Patient taking chemotherapy and/or radiotherapy.

Sites / Locations

  • Tanta University HospitalsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Control Group

Erector Spinae Block (ESB) group

Thoracic Paravertebral Block group

Arm Description

Patients of this group will receive standard treatment for herpes zoster which include acyclovir 800 mg, 5 times daily administered orally within the first 72 hours and analgesics as needed.

Patients of this group will receive 25 mg bupivacaine 0.5%, plus 8 mg dexamethasone in a total volume of 10 ml (The final Patients of this group will receive 25 mg bupivacaine 0.5%, plus 8 mg dexamethasone in a total volume of 10 ml(The final concentration of bupivacaine will be 0.25%) to be injected beneath the erector spinae muscle sheath) at the desired level under ultrasonography. The concentration of bupivacaine will be 0.25%) to be injected beneath the erector spinae muscle sheath) at the desired level under ultrasonography.

Patients will receive 25 mg bupivacaine 0.5%, plus 8mg dexamethasone in a total volume of 10 ml(The final concentration of bupivacaine will be 0.25%) to be injected in the Paravertebral space at the desired level under ultrasonography

Outcomes

Primary Outcome Measures

The incidence of post herpetic neuralgia (PHN)
Persistent herpetic pain after 3 months will reported as post herpetic neuralgia (PHN)

Secondary Outcome Measures

Visual Analog Scale
Visual Analog Scale (VAS) at baseline, 3, 4, 12, 24 weeks
Total consumption of rescue analgesia
Rescue analgesia in the form of Acetaminophen in a dose of 1,000 mg will be given if Visual Analog Scale (VAS) ≥4
The times of complete resolution of pain
The times of complete resolution of pain (from the date of block until complete disappearance of herpetic pain)
Adverse effects and complications
Hypotension Pneumothorax Local anesthetic toxicity Respiratory depression

Full Information

First Posted
December 4, 2020
Last Updated
December 6, 2020
Sponsor
Tanta University
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1. Study Identification

Unique Protocol Identification Number
NCT04656821
Brief Title
Erector Spinae Block Versus Thoracic Paravertebral Block for Acute Thoracic Herpes Zoster
Official Title
Ultrasound Guided Erector Spinae Block Versus Ultrasound Guided Thoracic Paravertebral Block for Pain Relief in Patients With Acute Thoracic Herpes Zoster
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 5, 2020 (Actual)
Primary Completion Date
June 6, 2021 (Anticipated)
Study Completion Date
June 20, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University

4. Oversight

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

5. Study Description

Brief Summary
The aim of this research is to study and compare the efficacy and safety of single injection erector spinae plane block and thoracic paravertebral block in prevention of post herpetic neuralgia in patients with acute thoracic herpes zoster.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Thoracic Herpes Zoster, Erector Spinae Plane Block, Thoracic Paravertebral Block, Pain Relief

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Patients of this group will receive standard treatment for herpes zoster which include acyclovir 800 mg, 5 times daily administered orally within the first 72 hours and analgesics as needed.
Arm Title
Erector Spinae Block (ESB) group
Arm Type
Experimental
Arm Description
Patients of this group will receive 25 mg bupivacaine 0.5%, plus 8 mg dexamethasone in a total volume of 10 ml (The final Patients of this group will receive 25 mg bupivacaine 0.5%, plus 8 mg dexamethasone in a total volume of 10 ml(The final concentration of bupivacaine will be 0.25%) to be injected beneath the erector spinae muscle sheath) at the desired level under ultrasonography. The concentration of bupivacaine will be 0.25%) to be injected beneath the erector spinae muscle sheath) at the desired level under ultrasonography.
Arm Title
Thoracic Paravertebral Block group
Arm Type
Experimental
Arm Description
Patients will receive 25 mg bupivacaine 0.5%, plus 8mg dexamethasone in a total volume of 10 ml(The final concentration of bupivacaine will be 0.25%) to be injected in the Paravertebral space at the desired level under ultrasonography
Intervention Type
Drug
Intervention Name(s)
Control Rx
Intervention Description
Patients of this group will receive standard treatment for herpes zoster which include acyclovir 800 mg, 5 times daily administered orally within the first 72 hours and analgesics as needed
Intervention Type
Procedure
Intervention Name(s)
Erector Spinae Block
Intervention Description
Patients of this group will receive 25 mg bupivacaine 0.5%, plus 8 mg dexamethasone in a total volume of 10 ml (The final concentration of bupivacaine will be 0.25%) to be injected beneath the erector spinae muscle sheath) at the desired level under ultrasonography.
Intervention Type
Procedure
Intervention Name(s)
Thoracic Paravertebral Block
Intervention Description
Patients of this group will receive 25 mg bupivacaine 0.5% , plus 8mg dexamethasone in a total volume of 10 ml(The final concentration of bupivacaine will be 0.25%) to be injected in the Paravertebral space at desired level under ultrasonography
Primary Outcome Measure Information:
Title
The incidence of post herpetic neuralgia (PHN)
Description
Persistent herpetic pain after 3 months will reported as post herpetic neuralgia (PHN)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Visual Analog Scale
Description
Visual Analog Scale (VAS) at baseline, 3, 4, 12, 24 weeks
Time Frame
6 months
Title
Total consumption of rescue analgesia
Description
Rescue analgesia in the form of Acetaminophen in a dose of 1,000 mg will be given if Visual Analog Scale (VAS) ≥4
Time Frame
6 months
Title
The times of complete resolution of pain
Description
The times of complete resolution of pain (from the date of block until complete disappearance of herpetic pain)
Time Frame
3 months
Title
Adverse effects and complications
Description
Hypotension Pneumothorax Local anesthetic toxicity Respiratory depression
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
51 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Over 50 years of age Chest wall herpetic eruption of less than one week Moderate or severe pain Exclusion Criteria: Patient refusal Eruption more than one week duration Patients who will not receive appropriate anti-viral therapy Patients with mild pain Infection at the site of injection Patients with a history of renal, hepatic diseases, coagulopathy, steroid therapy, malignancies. Patient taking chemotherapy and/or radiotherapy.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Esraa Hassan Abdelwahab, MSc
Phone
+201010473318
Email
esraa.hassan@med.tanta.edu.eg
Facility Information:
Facility Name
Tanta University Hospitals
City
Tanta
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Esraa Hassan Abdelwahab, MSc
Phone
+201010473318
Email
esraa.hassan@med.tanta.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The data will be available upon a reasonable request

Learn more about this trial

Erector Spinae Block Versus Thoracic Paravertebral Block for Acute Thoracic Herpes Zoster

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