Ultrasound Guidance Intercostobrachial Nerve Block in AVF Superficialization
Effect of Two Different Volumes of Ultrasound-Guided Distal Intercostobrachial Nerve Block on Block Success During Arteriovenous Fistula Superficialization Surgery
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
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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)
Exclusion criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Distal Intercostobrachial Nerve Block with large vloume
Distal Intercostobrachial Nerve Block will be conducted with 12 millimeters of Bupivacaine 0.25%. |
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 |
|
Experimental: Distal Intercostobrachial Nerve Block with small vloume
Distal Intercostobrachial Nerve Block will be conducted with 6 millimeters of Bupivacaine 0.25 % |
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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Comparing the incidence of successful complete sensory block
Time Frame: baseline
|
successful complete sensory block between the two techniques at 30 minutes after injection using cold sensitivity test. |
baseline
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
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
Additional Relevant MeSH Terms
- Urogenital Diseases
- Pathologic Processes
- Male Urogenital Diseases
- Kidney Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Chronic Disease
- Disease Attributes
- Renal Insufficiency
- Renal Insufficiency, Chronic
- Pathological Conditions, Signs and Symptoms
- Kidney Failure, Chronic
Other Study ID Numbers
- AVF2026
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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