- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07305584
Comparative Study of Subcoracoid Tunnel Block Versus Costoclavicular Block
December 28, 2025 updated by: Marwa Mohamed Medhat, Zagazig University
Regional Anesthesia for Elderly Patients Undergoing Distal Upper Limb Surgeries: A Randomized Comparative Study of Subcoracoid Tunnel Block Versus Costoclavicular Block
The purpose of this study is to compare the analgesic outcomes (time to first analgesic request, total amount of analgesic consumption, and pain scores) following the ultrasound-guided subcoracoid tunnel block or costoclavicular block for elderly patients undergoing distal upper limb surgeries.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
70
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Marwa M Medhat, MD
- Phone Number: 01002828937
- Email: medhatmarwa9@gmail.com
Study Contact Backup
- Name: Howida A Kamal, MD
- Phone Number: 01225096755
- Email: K.Howida@yahoO.com
Study Locations
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-
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Zagazig, Egypt
- faculty of medicine,zagazig university Egypt
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Contact:
- Marwa M Medhat, MD
- Phone Number: 01002828937
- Email: medhatmarwa@gmail.com
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patients acceptance to share in the study.
- Patients with ASA physical status I-II.
- Patients with a body mass index (BMI): of 18.5-30 kg/m2.
- Patients undergoing distal upper limb surgeries not more than 2 hours.
Exclusion Criteria:
- Patients with a history of allergic reactions or contraindications to local anesthetics.
- Patients with significant comorbidities (e.g., severe cardiovascular, neurological, or musculoskeletal disorders).
- Patients with respiratory insufficiency.
- Patients with coagulation disorders or taking drugs affecting surgical hemostasis.
- Patients with pre-existing neurological deficits
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Group (S)
The patient will receive subcoracoid tunnel block
|
The probe will be placed with its proximal end towards the mid-clavicular point and distal end with a marker towards the apex of the axilla.
A medial tilt of the probe will demonstrate the posterior and medial cords, while a slight lateral tilt of the probe will demonstrate the lateral cord.
The needle entry point at the distal end of the probe will be marked.
By using the in-plane technique, the needle will be advanced from a caudal to cephalad direction.
The probe will be tilted medially, and the needle will be advanced to position its tip above the posterior or medial cord.
The probe will be tilted laterally.
The needle tip will be repositioned above the lateral cord, and the LA will be injected
|
|
Active Comparator: Group (C)
The patient will receive costoclavicular block
|
. The key anatomical structures will be identified under ultrasound: the pectoralis major muscle, subclavius muscle, and three brachial plexus cords (lateral, medial, and posterior) clustered tightly lateral to the axillary artery, along with the axillary artery and vein.
The needle will be inserted by the in-plane technique from lateral to medial.
The needle tip will be advanced through subcutaneous tissue and subclavius, aiming to land in the costoclavicular fascial plane between the cords, ideally between the lateral and posterior cords and superficial to the medial cord, without traversing neural structure by multipoint strategy, and local anesthesia will be injected.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
the onset time of sensory block
Time Frame: 5 minutes after the block
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the time interval between the end of total local anesthetic administration and complete sensory block
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5 minutes after the block
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
block performance time
Time Frame: time of performance of the block
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time of performance of the block
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|
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3. Time of first rescue analgesia(naluphine)
Time Frame: 24 hours postoperative
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24 hours postoperative
|
|
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Pain intensity
Time Frame: basal, one, 2, 4, 8, 12, 18, 24, and 24 hours postoperative
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10-point NRS [(0 = no pain, 10 = worst imaginable pain), 1-3: Mild pain (nagging, annoying, slightly interfering with activities of daily living (ADLs), 4 - 6: Moderate pain (significantly interfering with ADLs, 7 - 10: Severe pain (disabling, unable to perform ADLs)]
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basal, one, 2, 4, 8, 12, 18, 24, and 24 hours postoperative
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patient's satisfaction
Time Frame: 24 hours postoperative
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The patients will be asked to rate the overall degree of satisfaction of the analgesia by using a 5-points likert-like verbal scale (1 = very dissatisfied analgesia, 2 = dissatisfied analgesia, and 3 = neutral, 4=satisfied analgesia, and 5=very satisfied analgesia)
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24 hours postoperative
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Incidence of block complications
Time Frame: first 24 hours postoperative
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hematoma formation or paresthesia or local anesthetic systemic toxicity.
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first 24 hours postoperative
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Howida A Kamal, MD, faculty of medicine,zagazig university Egypt
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
January 1, 2026
Primary Completion (Estimated)
January 1, 2026
Study Completion (Estimated)
April 1, 2026
Study Registration Dates
First Submitted
December 12, 2025
First Submitted That Met QC Criteria
December 12, 2025
First Posted (Estimated)
December 26, 2025
Study Record Updates
Last Update Posted (Actual)
December 30, 2025
Last Update Submitted That Met QC Criteria
December 28, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- ZU-IRB#1885/7-Nov-2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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