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

Sponsor

Tanta University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04656821

Collaborator

(none)

Enrollment

Location

Arms

6.5

Anticipated Duration (Months)

13.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Thoracic Herpes Zoster Erector Spinae Plane Block Thoracic Paravertebral Block Pain Relief	Drug: Control Rx Procedure: Erector Spinae Block Procedure: Thoracic Paravertebral Block	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Ultrasound Guided Erector Spinae Block Versus Ultrasound Guided Thoracic Paravertebral Block for Pain Relief in Patients With Acute Thoracic Herpes Zoster

Actual Study Start Date :

Dec 5, 2020

Anticipated Primary Completion Date :

Jun 6, 2021

Anticipated Study Completion Date :

Jun 20, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Control Group 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.	Drug: Control Rx 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
Experimental: Erector Spinae Block (ESB) group 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.	Procedure: Erector Spinae Block 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.
Experimental: Thoracic Paravertebral Block group 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	Procedure: Thoracic Paravertebral Block 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

Arm

Intervention/Treatment

Active Comparator: Control Group

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.

Drug: Control Rx

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

Experimental: Erector Spinae Block (ESB) group

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.

Procedure: Erector Spinae Block

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.

Experimental: Thoracic Paravertebral Block group

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

Procedure: Thoracic Paravertebral Block

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Visual Analog Scale [6 months]
Visual Analog Scale (VAS) at baseline, 3, 4, 12, 24 weeks
Total consumption of rescue analgesia [6 months]
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 [3 months]
The times of complete resolution of pain (from the date of block until complete disappearance of herpetic pain)
Adverse effects and complications [1 day]
Hypotension Pneumothorax Local anesthetic toxicity Respiratory depression

Eligibility Criteria

Criteria

Ages Eligible for Study:

51 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tanta University Hospitals	Tanta		Egypt

Sponsors and Collaborators

Tanta University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Esraa Hassan Abdelwahab, Assistant lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Tanta University

ClinicalTrials.gov Identifier:

NCT04656821

Other Study ID Numbers:

32720/11/18

First Posted:

Dec 7, 2020

Last Update Posted:

Dec 8, 2020

Last Verified:

Dec 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Herpes Simplex

Herpes Zoster

Aneurysm, Dissecting

Study Results

No Results Posted as of Dec 8, 2020