- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07517809
Comparison Between Ultrasound-Guided Costoclavicular and Lateral-Sagittal Infraclavicular Brachial Plexus Blocks in Adult Distal Upper Limb Surgeries : A Randomized Controlled Trial
Study Overview
Status
Conditions
Detailed Description
Regional anesthesia is commonly used for distal upper limb surgeries as it provides effective surgical anesthesia, reduces opioid consumption, and offers prolonged postoperative analgesia. Ultrasound-guided infraclavicular brachial plexus block is a well-established technique for these procedures. The traditional lateral-sagittal infraclavicular approach (LS-ICB) provides reliable anesthesia but may require multiple needle redirections to achieve adequate spread of local anesthetic around the cords of the brachial plexus. The costoclavicular (CC) approach is a newer ultrasound-guided infraclavicular technique in which the three cords of the brachial plexus are clustered together in the costoclavicular space, potentially allowing easier needle placement and faster spread of local anesthetic.
This prospective randomized controlled trial will include 50 adult patients undergoing distal upper limb surgery under regional anesthesia. Participants will be randomly assigned into two equal groups (25 patients each). Group CC will receive an ultrasound-guided costoclavicular brachial plexus block, while Group ICB will receive an ultrasound-guided lateral-sagittal infraclavicular brachial plexus block.
In both groups, the block will be performed using a mixture of 2% lidocaine and 0.5% bupivacaine in a 1:1 ratio with a total volume of 0.3 mL/kg, administered under real-time ultrasound guidance.
The primary outcome of the study is the time to onset of complete sensory and motor blockade after injection of the local anesthetic solution. Sensory block will be assessed using pinprick testing in the distributions of the median, ulnar, radial, and musculocutaneous nerves.
Secondary outcomes include block performance time, block success rate, incidence of complications (such as vascular puncture, pneumothorax, or local anesthetic systemic toxicity), postoperative pain scores, and total analgesic consumption during the first 24 hours after surgery. The findings of this study may help identify the most effective and safe infraclavicular block technique for distal upper limb surgeries.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ahmed Hesham Shahin, M.B.B.CH
- Phone Number: +201270857308
- Email: 160634@med.asu.edu.eg
Study Locations
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Cairo, Egypt
- Recruiting
- Ain Shams University Hospitals
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Contact:
- offices of professor D. Vice President
- Phone Number: +20226947820
- Email: info@ainshams.edu.eg
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- ASA physical status I-III
- Distal upper limb surgery requiring brachial plexus block.
- Patient approval after written and informed consent to participate.
Exclusion Criteria:
- Patient refusal.
- Allergy to drugs used.
- Infection at puncture site.
- Coagulopathy or anticoagulant therapy.
- Pre-existing neuropathy or neurological deficit in the affected limb.
- Severe pulmonary disease.
- BMI > 40 kg/m².
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Lateral-sagittal infraclavicular block (LS-ICB) group
Drug : A mixture of 2% lidocaine and 0.5% bupivacaine with volume of 0.3 mL/kg and a ratio of 1:1.
|
Ultrasound-guided lateral-sagittal infraclavicular brachial plexus block performed using a high-frequency linear probe.
A mixture of 2% lidocaine and 0.5% bupivacaine (1:1 ratio) with a total volume of 0.3 mL/kg is injected around the cords of the brachial plexus under real-time ultrasound guidance.
|
|
Active Comparator: Costoclavicular block brachial plexus (CC) group
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Ultrasound-guided costoclavicular brachial plexus block performed using a high-frequency linear probe.
A mixture of 2% lidocaine and 0.5% bupivacaine (1:1 ratio) with a total volume of 0.3 mL/kg is injected in the costoclavicular space around the cords of the brachial plexus under real-time ultrasound guidance.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to onset of complete sensory and motor block
Time Frame: From completion of injection up to 30 minutes after block performance
|
Time from completion of local anesthetic injection to achievement of complete sensory and motor blockade.
Sensory block will be assessed using pinprick testing in the distributions of the median, ulnar, radial, and musculocutaneous nerves.
Motor block will be graded using a standardized motor scale.
And time will be in minutes and seconds.
|
From completion of injection up to 30 minutes after block performance
|
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
Other Study ID Numbers
- FMASU MS 101/2026
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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