NCT06756347

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 24, 2024

Completed
8 days until next milestone

Study Start

First participant enrolled

January 1, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 3, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

January 3, 2025

Status Verified

January 1, 2025

Enrollment Period

1 year

First QC Date

December 24, 2024

Last Update Submit

January 2, 2025

Conditions

Regional Anesthesia

Outcome Measures

Primary Outcomes (1)

  • Success Rate

    Proportion of patients achieving adequate anesthesia (complete sensory block) within 30 minutes of administration.

    30 minutes

Study Arms (2)

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

Procedure: Patients receiving landmark-based brachial plexus blocksDrug: 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

Procedure: Landmark-Based Brachial Plexus BlockDrug: Bupivacaine

Interventions

Patients receiving landmark-based brachial plexus blocksPROCEDURE

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

Ultrasound-Guided Group
Landmark-Based Brachial Plexus BlockPROCEDURE

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.

Landmark-Based Group
BupivacaineDRUG

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

Landmark-Based GroupUltrasound-Guided Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ● Adult patients aged 18-65 years undergoing upper limb surgery requiring brachial plexus block.
  • Patients capable of providing informed consent

You may not qualify if:

  • ● 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 26066385RESULT

MeSH Terms

Interventions

Bupivacaine

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Central Study Contacts

Tarek Ashraf Ibrahim Abd Al-Hafiz, resident doctor

CONTACT

+201092002284tarek.15235463@med.aun.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident doctor at Assiut University hospital

Study Record Dates

First Submitted

December 24, 2024

First Posted

January 3, 2025

Study Start

January 1, 2025

Primary Completion

January 1, 2026

Study Completion

March 1, 2026

Last Updated

January 3, 2025

Record last verified: 2025-01