Ultrasound Guided Serratus Anterior Versus Erector Spinae Block in Pain Alleviation in Acute Herpes Zoster

June 26, 2024 updated by: Mina Maher, Minia University

Ultrasound Guided Serratus Anterior Versus Erector Spinae Block in Pain Alleviation in Acute Herpes Zoster: A Prospective Comparative Study

Acute herpes zoster pain is very severe . Conventional analgesics may be of no value. Regional blocks may play a role

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult population between 30 and 75 years old.
  • Unilateral painful thoracic herpetic eruption of less than one week duration.
  • VAS more than or equal 4, persistent pain in spite of proper antiviral and analgesic therapy, (800 mg oral acyclovir, 5 times per day, for one week), pregabalin 300 mg per day, acetaminophen 1000 mg per day, topical calamine lotion).

Exclusion Criteria:

  • Diabetic patients.
  • Painful herpetic eruptive vesicles more than one week.
  • Abdominal herpetic eruptions.
  • Non-compliant on anti-viral (bulbar palsy for example).
  • Co-malignancy or radiotherapy.
  • Steroid therapy > 5 mg prednisolone or its equivalent.
  • Infections or hematoma at site of injection.
  • Coagulopathy (chronic kidney or liver disease, clopidogrel use).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
800 mg acyclovir, 5 times / day, orally administered, for one week, acetaminophen 1000 mg per day, topical calamine lotion)
Active Comparator: Erector spinae group
800 mg acyclovir, 5 times / day, orally administered, for one week, acetaminophen 1000 mg per day, topical calamine lotion)+ 25 ml bupivacaine 0.25% plus 8 mg dexamethasone
Procedure: ultrasound guided erector spine block
Ultrasound guided thoracic erector spinae block
Active Comparator: Serratus anterior group
800 mg acyclovir, 5 times / day, orally administered, for one week, acetaminophen 1000 mg per day, topical calamine lotion)+ 25 ml bupivacaine 0.25% plus 8 mg dexamethasone
Procedure: Serratus anterior block
Ultrasound guided serratus anterior block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain score
Time Frame: immediate after injection, 1 week, 1, 3 months
Visual analogue scale from 0 to 10. 0= NO pain, 1-3=mild tolerable pain, 4-6= moderate pain, 7-10= severe untearable pain.
immediate after injection, 1 week, 1, 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with pain recurrence
Time Frame: 1 week, 1, and 3 months
Number of patients in need for re-injection
1 week, 1, and 3 months
analgesic consumption
Time Frame: 1 week, 1, and 3 months
total amount dose of analgesics used
1 week, 1, and 3 months
Incidence of treatment related adverse events
Time Frame: immediately after injection
hypotension, bradyarrhythmia, hematoma
immediately after injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Minia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 5, 2024

Primary Completion (Estimated)

April 15, 2025

Study Completion (Estimated)

April 15, 2025

Study Registration Dates

First Submitted

June 15, 2024

First Submitted That Met QC Criteria

June 20, 2024

First Posted (Actual)

June 26, 2024

Study Record Updates

Last Update Posted (Actual)

June 27, 2024

Last Update Submitted That Met QC Criteria

June 26, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1084

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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