Regional AnesthesiaNCT06756347
Comparative Analysis of Ultrasound-Guided Versus Landmark-Based Techniques for Regional Anesthesia in Egyptian Patients
A study testing Patients receiving landmark-based brachial plexus blocks, Landmark-Based Brachial Plexus Block and Bupivacaine in people with Regional Anesthesia, run by Assiut University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Regional Anesthesia
- What is being tested?
- Patients receiving landmark-based brachial plexus blocks, Landmark-Based Brachial Plexus Block and Bupivacaine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 1 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ● Adult patients aged 18-65 years undergoing upper limb surgery requiring brachial plexus block.
- Patients capable of providing informed consent
Who cannot join
- ● 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Tarek Ashraf Ibrahim Abd Al-Hafiz, resident doctor contact
About this study
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.
Read the 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
- Being tested
- Patients receiving landmark-based brachial plexus blocks, Landmark-Based Brachial Plexus Block, Bupivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients receiving landmark-based brachial plexus blocksProcedure or surgery
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
Landmark-Based Brachial Plexus BlockProcedure or surgery
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.
BupivacaineDrug
injected in both group as local anesthetic agent ( at a standardized concentration and volume) to ensure comparability.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound-Guided Group | Active comparator | 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 Receives: Procedure: Patients receiving landmark-based brachial plexus blocks; Drug: Bupivacaine |
| Landmark-Based Group | Active comparator | Patients receiving landmark-based brachial plexus blocks.o Procedure performed based on anatomical landmarks and palpation, without imaging assistance Receives: Procedure: Landmark-Based Brachial Plexus Block; Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success Rate
Proportion of patients achieving adequate anesthesia (complete sensory block) within 30 minutes of administration.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2025
- Study start1 Jan 2025 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Regional AnesthesiaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tarek Ashraf Ibrahim Abd Al-Hafiz, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06756347
- Sponsor's protocol ID
- US-Guided vs Land mark RA
- Status last verified
- Jan 2025
- First submitted
- 24 Dec 2024
- Last updated
- 3 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 26066385
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Analysis of Ultrasound-Guided Versus Landmark-Based Techniques for Regional Anesthesia in Egyptian Patients
- ClinicalTrials.gov ID
- NCT06756347
- Acronym / sponsor ID
- US-Guided vs Land mark RA
- Conditions
- Regional Anesthesia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 3 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound-Guided Group | Active comparator | Procedure: Patients receiving landmark-based brachial plexus blocks, Drug: BupivacainePatients 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 |
| Landmark-Based Group | Active comparator | Procedure: Landmark-Based Brachial Plexus Block, Drug: BupivacainePatients receiving landmark-based brachial plexus blocks.o Procedure performed based on anatomical landmarks and palpation, without imaging assistance |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ● Adult patients aged 18-65 years undergoing upper limb surgery requiring brachial plexus block.
Key exclusion criteria (4 listed)
- ● Patients with contraindications to regional anesthesia (e.g., infection at the site, severe coagulopathy).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patients receiving landmark-based brachial plexus blocksThe 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 | Procedure or surgery | Ultrasound-Guided Group |
| Landmark-Based Brachial Plexus BlockThe 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. | Procedure or surgery | Landmark-Based Group |
| Bupivacaineinjected in both group as local anesthetic agent ( at a standardized concentration and volume) to ensure comparability. | Drug | Landmark-Based Group, Ultrasound-Guided Group |
Primary outcome
Success Rate
Time frame: 30 minutes
Proportion of patients achieving adequate anesthesia (complete sensory block) within 30 minutes of administration.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2025.
- Results publication: PubMed 26066385Sivashanmugam 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tarek Ashraf Ibrahim Abd Al-Hafiz, resident doctor contact
Questions about this trial
What is this clinical trial studying?
A study testing Patients receiving landmark-based brachial plexus blocks, Landmark-Based Brachial Plexus Block and Bupivacaine in people with Regional Anesthesia, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tarek Ashraf Ibrahim Abd Al-Hafiz, resident doctor (+201092002284, tarek.15235463@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success Rate (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06756347, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2025.