- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07256145
Comparison Between the Efficacy of Ultrasound-guided Erector Spinae Plane Block and Conventional Treatment for Pain Management in Patients With Post-herpetic Neuralgia
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The current study will be conducted as a single-blinded prospective randomized controlled study to evaluate the efficacy of ultrasound-guided erector spinae plane block with steroids to relieve pain in cases of post-herpetic neuralgia.
All patients will be evaluated by:
- Full history taking: including age, sex, presence of co-morbid conditions as well as the presenting complaint.
Clinical examination and routine lab investigations that include:
- Complete blood count (CBC).
- Fasting blood glucose (FBG).
- Coagulation profile (bleeding time, prothrombin time, prothrombin activity, international normalized ratio).
Measurements:
Patients will be followed up at 24 hours, 1 week, and 6 weeks after injection.
The following measurements will be recorded:
- Pain will be assessed pre- and post-injection using VAS score at 24 hours, 1 week, and 6 weeks post-injection.
- Need for analgesic intake post-injection will be assessed at the follow-up periods.
- Patient satisfaction using the SAPS score.
- Complications post-injection as pain, irritation or infection will be assessed.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Aleexandria
-
Alexandria, Aleexandria, Egypt, 21523
- Recruiting
- Alexandria University
-
Contact:
- yasmine ragab elsayed, MD
- Phone Number: 00201001972418
- Email: y_elsayed16@alexmed.edu.eg
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients with post-herpetic neuralgia not responding to medical treatment.
Exclusion Criteria:
- 1- Patient refusal 2- Age less than 20 years or older than 70 years. 3- Systemic Infection. 4-Patients with dementia or other diseases that could have impaired their memory or cognitive function.
5- Immunocompromised patients, severe osteoporosis, and uncontrolled diabetes mellitus.
Study Plan
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: conventional group
|
|
|
Experimental: Injection group
|
erector spinae plane block with steroids
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluate the efficacy of ultrasound-guided erector spinae plane block with steroids to relieve pain in cases of post-herpetic neuralgia
Time Frame: 6 weeks
|
by VAS score
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient satisfaction
Time Frame: 6 weeks
|
SAPS score
|
6 weeks
|
|
Complications
Time Frame: 6 weeks
|
As pain, irritation or infection
|
6 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0307429
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Post-Herpetic Neuralgia
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Grünenthal GmbHCompletedPost Herpetic Neuralgia
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Novartis PharmaceuticalsTerminatedPost-herpetic NeuralgiaAustralia, Taiwan, Germany, France, Portugal, Czechia, United Kingdom, Hungary, Spain, Slovakia, Japan, Canada, Denmark, Norway, Austria, Belgium, Poland, Italy, Korea, Republic of
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Bial - Portela C S.A.Terminated
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NeurAxon Inc.CompletedPost Herpetic NeuralgiaUnited States, Canada
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Odense University HospitalCompletedPost Herpetic NeuralgiaDenmark
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DepomedCompletedPost Herpetic NeuralgiaUnited States
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University of Sao PauloCompletedPost-herpetic Neuralgia
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Bristol-Myers SquibbCompleted
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