Classic Versus Interfascial Axillary Block in Hand, Wrist, and Forearm Surgery
Comparison of Axillary Block and Interfascial Axillary Block in Terms of Block Success and Intraoperative Clinical Efficacy in Hand, Wrist, and Forearm Surgery: A Prospective Randomized Study
Hand, wrist, and forearm surgeries are commonly performed procedures with significant postoperative pain potential. Regional anesthesia of the brachial plexus via the axillary approach is one of the gold-standard techniques for distal upper-limb surgery. In the conventional (classic) axillary block, the median, ulnar, and radial nerves within the axillary sheath are individually targeted under ultrasound guidance; however, anatomical septations around the axillary artery may prevent homogeneous spread of local anesthetic, leading to a patchy block and reduced intraoperative success.
The interfascial axillary block is a modified approach in which local anesthetic is deposited into the fascial planes between the axillary muscles rather than directly into the nerve sheath, aiming for passive diffusion, homogeneous spread, and fewer needle manipulations. This prospective, randomized, single-center study compares the classic axillary block with the interfascial axillary block in patients undergoing hand, wrist, and forearm surgery, primarily in terms of surgical anesthesia adequacy (block success).
Studienübersicht
Status
Intervention / Behandlung
Detaillierte Beschreibung
This is a prospective, randomized, single-center clinical trial conducted in a Department of Anesthesiology and Reanimation. Randomization is performed using the sealed-envelope method. A total of 110 patients (55 per group) aged 18-90 years, American society of anesthesiologists physical status I-III, scheduled for elective hand, wrist, or forearm surgery under ultrasound-guided regional anesthesia will be enrolled.
Group 1 (Classic Axillary Block) receives an ultrasound-guided block targeting the median, ulnar, and radial nerves perineurally/perivascularly within the axillary sheath. Group 2 (Interfascial Axillary Block) receives an ultrasound-guided injection of local anesthetic into the potential fascial planes between the axillary muscles, relying on passive diffusion.
The primary outcome is surgical anesthesia adequacy (block success). Secondary outcomes include block application time, sensory and motor block onset, rates of additional local infiltration and conversion to general anesthesia, intraoperative additional analgesic/sedation requirements, hemodynamic parameters, patient and surgeon satisfaction, and complications.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Korgün Ökmen, PhD.
- Telefonnummer: 05057081021
- E-Mail: korgunokmen@gmail.com
Studienorte
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Bursa, Türkei (türkiye), 16110
- Bursa Yuksek Ihtisas Training and Research Hospital
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
Inclusion Criteria:
- Aged 18-90 years
- American society of anesthesiologists physical status I-II-III
- Scheduled for elective hand, wrist, or forearm surgery
- Written informed consent obtained
Exclusion Criteria:
- History of local anesthetic allergy
- Coagulation disorder
- BMI > 40 kg/m²
- Infection at the block site
- Chronic pain syndrome
- Pregnancy
- Inability to communicate
- Need for emergency surgery
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Aktiver Komparator: Classic Axillary Block
Ultrasound-guided classic axillary brachial plexus block.
The median, ulnar, and radial nerves within the axillary sheath around the axillary artery are targeted individually by perineural/perivascular injection of local anesthetic.
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Classic (perivascular/perineural) axillary brachial plexus block
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Aktiver Komparator: Interfascial Axillary Block
Ultrasound-guided interfascial axillary block.
Local anesthetic is injected into the potential fascial planes between the axillary muscles rather than directly into the nerve sheath, allowing passive diffusion of the drug.
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Interfascial (fascial-plane) axillary brachial plexus block.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Surgical anesthesia adequacy (block success)
Zeitfenster: 30 minutes after block
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Complete sensory and motor blockade of the surgical field, allowing the operation to be completed without additional local infiltration or conversion to general anesthesia
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30 minutes after block
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Block application time
Zeitfenster: intraoperative
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time from needle insertion to withdrawal.
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intraoperative
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Sensory block onset time
Zeitfenster: 5., 10., 15., 30. minutes
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Pin-Prick test in the median, ulnar, radial, and musculocutaneous dermatomes (0: normal, 1: blunt, 2: no sensation).
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5., 10., 15., 30. minutes
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Motor block onset time
Zeitfenster: 5., 10., 15., 30. minutes
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5., 10., 15., 30. minutes
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Intraoperative additional analgesic/sedation consumption
Zeitfenster: intraoperative
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intraoperative
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Patient and surgeon satisfaction
Zeitfenster: end of surgery
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4-point Likert scale (1: very poor, 4: very good)
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end of surgery
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Mitarbeiter und Ermittler
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- BursaYIEAH-2026-1
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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