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Ultrasound Guidance Intercostobrachial Nerve Block in AVF Superficialization

2026年10月3日 更新者:Ahmed Mahmood Ahmed Mohammed、Assiut University

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

調査の概要

詳細な説明

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.

研究の種類

介入

入学 (推定)

76

段階

  • 適用できない

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年~60年 (大人)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:他の
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
実験的: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

実験的: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

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Comparing the incidence of successful complete sensory block
時間枠:baseline

successful complete sensory block between the two techniques at 30 minutes after injection using cold sensitivity test.

baseline

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研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年10月1日

一次修了 (推定)

2027年12月1日

研究の完了 (推定)

2028年3月1日

試験登録日

最初に提出

2026年9月24日

QC基準を満たした最初の提出物

2026年9月30日

最初の投稿 (実際)

2026年10月1日

学習記録の更新

投稿された最後の更新 (実際)

2026年10月7日

QC基準を満たした最後の更新が送信されました

2026年10月3日

最終確認日

2026年10月1日

詳しくは

本研究に関する用語

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

米国で製造され、米国から輸出された製品。

はい

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