Distal Upper Limb SurgeriesNCT07305584
Comparative Study of Subcoracoid Tunnel Block Versus Costoclavicular Block
A study testing subcoracoid tunnel block and Costoclavicular block in people with Distal Upper Limb Surgeries, run by Zagazig University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Distal Upper Limb Surgeries
- What is being tested?
- subcoracoid tunnel block and Costoclavicular block
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2026to 1 Apr 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 65 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
faculty of medicine,zagazig university Egypt
Zagazig
Marwa M Medhat, MD, 01002828937, medhatmarwa@gmail.com
About this study
Official title: 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.
- Conditions
- Distal Upper Limb Surgeries
- Being tested
- subcoracoid tunnel block, Costoclavicular block
- Keywords
- distal Upper Limb Surgeries Subcoracoid Tunnel Block Costoclavicular Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
subcoracoid tunnel blockOther
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
Costoclavicular blockOther
. 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.
| Study group | Role | What they receive |
|---|---|---|
| Group (S) | Active comparator | The patient will receive subcoracoid tunnel block Receives: Other: subcoracoid tunnel block |
| Group (C) | Active comparator | The patient will receive costoclavicular block Receives: Other: Costoclavicular block |
What is being measured
The primary outcome is the main question the study is designed to answer.
the onset time of sensory block
the time interval between the end of total local anesthetic administration and complete sensory block
Measured: 5 minutes after the block
Secondary outcomes (5)
block performance time
Measured: time of performance of the block
3. Time of first rescue analgesia(naluphine)
Measured: 24 hours postoperative
Pain intensity
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)]
Measured: basal, one, 2, 4, 8, 12, 18, 24, and 24 hours postoperative
patient's satisfaction
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)
Measured: 24 hours postoperative
Incidence of block complications
hematoma formation or paresthesia or local anesthetic systemic toxicity.
Measured: first 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2025
- Study start1 Jan 2026 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Apr 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 Distal Upper Limb SurgeriesStudies of the same condition, open and under way.
- More trials run by Zagazig 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Marwa Mohamed Medhat, Zagazig University
- Investigators
- Howida A Kamal, MD, Study director, faculty of medicine,zagazig university Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07305584
- Sponsor's protocol ID
- ZU-IRB#1885/7-Nov-2025
- Status last verified
- Dec 2025
- First submitted
- 12 Dec 2025
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kaya S, Sahap M, Demirtas K. Comparison of costoclavicular and lateral sagittal infraclavicular approaches in ultrasound-guided brachial plexus block. Agri. 2025 Jan;37(1):32-41. doi: 10.14744/agri.2024.34022.
PubMed 39835953
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regional Anesthesia for Elderly Patients Undergoing Distal Upper Limb Surgeries: A Randomized Comparative Study of Subcoracoid Tunnel Block Versus Costoclavicular Block
- ClinicalTrials.gov ID
- NCT07305584
- Acronym / sponsor ID
- ZU-IRB#1885/7-Nov-2025
- Conditions
- Distal Upper Limb Surgeries
- Keywords
- distal Upper Limb Surgeries Subcoracoid Tunnel Block Costoclavicular Block
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 26 Dec 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group (S) | Active comparator | Other: subcoracoid tunnel blockThe patient will receive subcoracoid tunnel block |
| Group (C) | Active comparator | Other: Costoclavicular blockThe patient will receive costoclavicular block |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| subcoracoid tunnel blockThe 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 | Other | Group (S) |
| 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. | Other | Group (C) |
Primary outcome
the onset time of sensory block
Time frame: 5 minutes after the block
the time interval between the end of total local anesthetic administration and complete sensory block
5 secondary outcomes
block performance time
Time frame: time of performance of the block
3. Time of first rescue analgesia(naluphine)
Time frame: 24 hours postoperative
Pain intensity
Time frame: basal, one, 2, 4, 8, 12, 18, 24, and 24 hours postoperative
patient's satisfaction
Time frame: 24 hours postoperative
Incidence of block complications
Time frame: first 24 hours postoperative
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 30 Dec 2025.
- Background: PubMed 39835953Kaya S, Sahap M, Demirtas K. Comparison of costoclavicular and lateral sagittal infraclavicular approaches in ultrasound-guided brachial plexus block. Agri. 2025 Jan;37(1):32-41. doi: 10.14744/agri.2024.34022.
- Individual participant dataSharing planned: Undecided
Related trials for Distal Upper Limb Surgeries
Active, not recruiting
Immediate Mobilization Versus 2 Weeks Cast Immobilization After Distal Radius Fracture Treated With Volar Locking Plate
Distal Radius Fracture
RecruitingPhase 1
Impact of Early ADL Education on Outcomes Post DRF ORIF
Distal Radius Fractures
Not yet recruiting
Tourniquet Pain Prevention During Distal Upper Limb Surgery
Analgesia
Not yet recruiting
Distal Versus Conventional Radial Arterial Catheterization for Arterial Waveform Stability
Intraoperative Arterial Blood Pressure Monitoring, Arterial Catheter Dysfunction
Not yet recruitingObservational study
Early Detection of Ulnar Sparing After Supraclavicular Block Using Infrared Thermography and Perfusion Index
Elective Upper Limb Surgery Distal to the Elbow
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.
Howida A Kamal, MD study director
faculty of medicine,zagazig university Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing subcoracoid tunnel block and Costoclavicular block in people with Distal Upper Limb Surgeries, run by Zagazig University at 1 site in Egypt.
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 4 inclusion and 5 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 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Marwa M Medhat, MD (01002828937, medhatmarwa9@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the onset time of sensory block (time frame: 5 minutes after the block). 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 NCT07305584, 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 30 Dec 2025.