Comparative Analysis of Ultrasound-Guided Versus Landmark-Based Techniques for Regional Anesthesia in Egyptian Patients

NCT ID: NCT06756347

Last Updated: 2025-01-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2026-03-01

Brief Summary

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.

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.

Conditions

Regional Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Patients receiving landmark-based brachial plexus blocks

Intervention Type: PROCEDURE

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

Bupivacaine

Intervention Type: DRUG

injected in both group as local anesthetic agent ( at a standardized concentration and volume) to ensure comparability.

Landmark-Based Group

Patients receiving landmark-based brachial plexus blocks.o Procedure performed based on anatomical landmarks and palpation, without imaging assistance

Group Type: ACTIVE_COMPARATOR

Landmark-Based Brachial Plexus Block

Intervention Type: PROCEDURE

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.

Bupivacaine

Intervention Type: DRUG

injected in both group as local anesthetic agent ( at a standardized concentration and volume) to ensure comparability.

Interventions

Patients receiving landmark-based brachial plexus blocks

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

Intervention Type: PROCEDURE

Landmark-Based Brachial Plexus Block

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.

Intervention Type: PROCEDURE

Bupivacaine

injected in both group as local anesthetic agent ( at a standardized concentration and volume) to ensure comparability.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Tarek Ashraf Ibrahim Abd Al-Hafiz

resident doctor at Assiut University hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Tarek Ashraf Ibrahim Abd Al-Hafiz, resident doctor

Role: CONTACT

tarek.15235463@med.aun.edu.eg

+201092002284

References

Sivashanmugam T, Ray S, Ravishankar M, Jaya V, Selvam E, Karmakar MK. Randomized Comparison of Extrafascial Versus Subfascial Injection of Local Anesthetic During Ultrasound-Guided Supraclavicular Brachial Plexus Block. Reg Anesth Pain Med. 2015 Jul-Aug;40(4):337-43. doi: 10.1097/AAP.0000000000000264.

Reference Type: RESULT

PMID: 26066385 (View on PubMed)

Other Identifiers

US-Guided vs Land mark RA

Identifier Type: -

Identifier Source: org_study_id