Supraclavicular Plexus Block Procedure (SCPB)NCT07852351

Ultrasound Guidance Intercostobrachial Nerve Block in AVF Superficialization

A study testing Distal Intercostobrachial Nerve Block and Supraclavicular Plexus Block Procedure (SCPB) in people with Supraclavicular Plexus Block Procedure (SCPB) and ESRD, run by Assiut University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record

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Trial summary

The present clinical study will be undertaken to evaluate and compare the clinical efficacy of two different volumes of distal ICBN block when combined with a baseline supraclavicular brachial plexus block during superficialization of upper arm arteriovenous fistula Read more about this study

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Supraclavicular Plexus Block Procedure (SCPB), ESRD
What is being tested?: Distal Intercostobrachial Nerve Block and Supraclavicular Plexus Block Procedure (SCPB)
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 76 participants
Where: No sites listed yet
Study dates: 1 Oct 2026to 1 Mar 2028
Phase: Interventional

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 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Adult patients aged 18 to 65 years of either sex
Patients scheduled for elective upper-arm AVF superficialization (brachiobasilic or brachiocephalic)
ASA physical status II, III (common in chronic kidney disease patients)

Who cannot join

Pre-existing peripheral neuropathy or severe neurological deficits in the operative upper extremity.
Cognitive impairment, psychiatric disorders, or an inability to comprehend and communicate the pain scoring scales
Patients on chronic opioid use
Local infection, severe dermatitis, or anatomical distortions at the proposed needle insertion sites.
Known allergy or hypersensitivity to local anesthetics.
Patient refusal of regional anesthesia techniques.

About this study

Official title: Effect of Two Different Volumes of Ultrasound-Guided Distal Intercostobrachial Nerve Block on Block Success During Arteriovenous Fistula Superficialization Surgery

Read the detailed description

Patients with chronic renal failure, particularly those with end-stage kidney disease, usually have multiple co-morbid conditions, and thus, regional anesthesia is usually preferred over general anesthesia (GA) in such cases Arteriovenous fistula (AVF) superficialization is a critical surgical procedure commonly performed in patients with end-stage renal disease to facilitate adequate hemodialysis access Ultrasound-guided brachial plexus block provides excellent surgical anesthesia for upper extremity procedures and is widely used during (AVF) creation. However, superficialization of the fistula often requires an extended incision and deeper dissection along the medial aspect of the arm. Because the intercostobrachial nerve (ICBN) originates from the second intercostal nerve (T2) rather than the brachial plexus, brachial plexus block alone does not provide reliable anesthesia of the axilla and upper medial arm supplied by the ICBN The skin and subcutaneous tissue in this specific region are heavily innervated by the ICBN, which originates as the lateral cutaneous branch of the second intercostal nerve (T2) and bypasses the brachial plexus entirely. Consequently, brachial plexus alone may not provide adequate anesthesia of the medial upper arm. So patients undergoing this procedure often experience sharp and intense intraoperative pain during medial skin tunneling and surgical manipulation if the ICBN is not separately anesthetized To address this anatomical challenge, ICBN block must be performed in conjunction with the primary brachial plexus blockade. Traditionally, a conventional landmark-guided subcutaneous infiltration has been used to block the ICBN as it emerges into the axillary fossa. However, this blind technique exhibits variable success rates and carries a risk of incomplete sensory coverage, and can lead to accidental vascular puncture in the highly vascular axillary region (Magazzeni et al., 2018). With the advancement of regional anesthesia, ultrasound-guided fascial plane blocks several approaches have been described, including , ultrasound-guided distal block, proximal block at the chest wall, and fascial plane techniques, with variable success rates reported among studies. One possible explanation for these inconsistent results is the considerable anatomical variability of the ICBN. Cadaveric studies have demonstrated variations in its origin, branching pattern, and communications with adjacent nerves. Furthermore, approximately one-third of ICBNs may receive contributions from neighboring intercostal nerves, potentially limiting the effectiveness of localized distal injections.In a randomized trial, Moustafa and Kandeel reported a complete sensory block success rate of only 51% using a distal ultrasound-guided ICBN block with 6 mL of local anesthetic, suggesting that distal blockade may not reliably anesthetize all relevant nerve branches. Given the considerable anatomical variability of the ICBN and its terminal branches, the extent of local anesthetic spread may influence the success of distal ICBN blockade. It is therefore plausible that larger injectate volumes may improve neural coverage and increase the probability of achieving complete sensory blockade. This hypothesis has not been specifically evaluated in previous clinical studies.

Conditions: Supraclavicular Plexus Block Procedure (SCPB), ESRD
Being tested: Distal Intercostobrachial Nerve Block, Supraclavicular Plexus Block Procedure (SCPB)
Keywords: esrd, Supraclavicular Plexus Block Procedure (SCPB)
Medical subject headings: Kidney Failure, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Distal Intercostobrachial Nerve BlockProcedure or surgery
Ultrasound Positioning and Administration: The transducer will be placed transversely across the inner aspect of the arm, directly beneath where the pectoralis major muscle attaches.
Infiltration Technique: Probe transversely across the axillary fold/proximal medial arm.
Identify pectoralis major anteriorly and latissimus dorsi posteriorly. The target is the subcutaneous plane superficial to the brachial fascia, spanning between these muscular boundaries.
Patients will be divided into two equal groups. Group H will be injected with 12 milliliters of bupivacaine 0.25%, and Group L will be injected with 6 milliliters of bupivacaine 0.25%, while advancing the needle so the LA forms a continuous subcutaneous spread from the pectoralis major side toward the latissimus dorsi side
Supraclavicular Plexus Block Procedure (SCPB)Procedure or surgery
supine with the head turned approximately 30° away from the surgical side, and a small towel will be positioned between the scapulae to optimize access. After aseptic preparation, a high-frequency linear US probe (6 - 12 MHz) covered with a sterile sheath will be placed in the coronal-oblique plane just superior to the clavicle and lateral to the sternocleidomastoid muscle to visualize the subclavian artery medially, the brachial plexus divisions as a cluster of hypoechoic round structures lateral to the artery, and the first rib and pleura as hyperechoic lines deep to the artery. Using an in-plane lateral-to-medial approach, a 22-G, 80-mm insulated block needle will be advanced under continuous US guidance toward the "corner pocket" bordered by the subclavian artery medially, the first rib inferiorly, and the brachial plexus laterally. After negative aspiration, Ten mL of bupivacaine 0.3% will be injected into the corner pocket. needle will be redirected to deposit additional 3 - 5 mL

Study groups in NCT07852351
Study group	Role	What they receive
Distal Intercostobrachial Nerve Block with large vloume	Experimental	Distal Intercostobrachial Nerve Block will be conducted with 12 millimeters of Bupivacaine 0.25%. Receives: Procedure: Supraclavicular Plexus Block Procedure (SCPB)
Distal Intercostobrachial Nerve Block with small vloume	Experimental	Distal Intercostobrachial Nerve Block will be conducted with 6 millimeters of Bupivacaine 0.25 % Receives: Procedure: Distal Intercostobrachial Nerve Block

What is being measured

The primary outcome is the main question the study is designed to answer.

Comparing the incidence of successful complete sensory block
successful complete sensory block between the two techniques at 30 minutes after injection using cold sensitivity test.
Measured: baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 20261 Mar 2028

First posted1 Oct 2026
Study start1 Oct 2026 (estimated)
Primary completion1 Dec 2027 (estimated)
Study completion1 Mar 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Supraclavicular Plexus Block Procedure (SCPB)Studies 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: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 76 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07852351
Sponsor's protocol ID: AVF2026
Status last verified: Oct 2026
First submitted: 24 Sep 2026
Last updated: 7 Oct 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No