- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06756347
Comparative Analysis of Ultrasound-Guided Versus Landmark-Based Techniques for Regional Anesthesia in Egyptian Patients
Regional anesthesia is a cornerstone in modern surgical practices due to its ability to provide effective pain management and reduce reliance on general anesthesia. Traditional landmark-based techniques, widely used due to their simplicity and cost-effectiveness, rely on surface anatomy and palpation to guide needle placement. However, these techniques are associated with a higher risk of complications, including failed blocks and nerve injuries.
Ultrasound-guided techniques have emerged as a safer, more precise alternative, offering real-time visualization of anatomical structures. Studies suggest that ultrasound guidance improves the success rate, reduces procedural time, and minimizes complications. Despite global advancements in ultrasound-guided regional anesthesia, limited research addresses its efficacy and safety specifically in Egyptian patients, whose unique anatomical and physiological characteristics may influence outcomes.
This study seeks to fill this knowledge gap and provide evidence-based guidance tailored to this population, focusing on brachial plexus blocks.
Study Overview
Status
Conditions
Detailed Description
Regional anesthesia is a cornerstone in modern surgical practices due to its ability to provide effective pain management and reduce reliance on general anesthesia. Traditional landmark-based techniques, widely used due to their simplicity and cost-effectiveness, rely on surface anatomy and palpation to guide needle placement. However, these techniques are associated with a higher risk of complications, including failed blocks and nerve injuries.
Ultrasound-guided techniques have emerged as a safer, more precise alternative, offering real-time visualization of anatomical structures. Studies suggest that ultrasound guidance improves the success rate, reduces procedural time, and minimizes complications. Despite global advancements in ultrasound-guided regional anesthesia, limited research addresses its efficacy and safety specifically in Egyptian patients, whose unique anatomical and physiological characteristics may influence outcomes.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Tarek Ashraf Ibrahim Abd Al-Hafiz, resident doctor
- Phone Number: +201092002284
- Email: tarek.15235463@med.aun.edu.eg
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
● Adult patients aged 18-65 years undergoing upper limb surgery requiring brachial plexus block.
- Patients capable of providing informed consent
Exclusion Criteria:
● Patients with contraindications to regional anesthesia (e.g., infection at the site, severe coagulopathy).
- History of severe allergic reactions to local anesthetics.
- Anatomical abnormalities affecting the brachial plexus block.
- Obesity (BMI > 35) or other conditions that might confound results.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Ultrasound-Guided Group
Patients receiving ultrasound-guided brachial plexus blocks .o
Procedure performed using a high-frequency linear ultrasound probe.Real-time visualization of the brachial plexus for precise anesthetic delivery
|
The operator will visualize anatomical structures in real time, identify the brachial plexus (supraclavicular approach), and guide the needle to the injection site under direct ultrasound visualization
injected in both group as local anesthetic agent ( at a standardized concentration and volume) to ensure comparability.
|
|
Active Comparator: Landmark-Based Group
Patients receiving landmark-based brachial plexus blocks.o
Procedure performed based on anatomical landmarks and palpation, without imaging assistance
|
injected in both group as local anesthetic agent ( at a standardized concentration and volume) to ensure comparability.
The operator will identify anatomical landmarks (e.g., interscalene groove, supraclavicular fossa) using palpation and surface anatomy.
The needle will be inserted based on these landmarks, with no direct visualization of internal structures.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Success Rate
Time Frame: 30 minutes
|
Proportion of patients achieving adequate anesthesia (complete sensory block) within 30 minutes of administration.
|
30 minutes
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Estimated)
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
- US-Guided vs Land mark RA
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.
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