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Comparison of 90° and 120° Arm Positions in Costoclavicular Block (COSTO-RCT)

6. Juni 2026 aktualisiert von: ALGAN TURGUT ÇARSANCAKLI, Ankara Etlik City Hospital

Effect of Arm Abduction Degree ( 90° vs. 120° ) on Block Onset Time and Block Success in Costoclavicular Brachial Plexus Block in Patients Undergoing Hand, Wrist and Forearm Surgery: A Prospective Randomized Controlled Trial

The costoclavicular approach of the infraclavicular brachial plexus block is widely used for upper extremity surgeries due to its reliable anatomy and high success rates. Patient positioning, particularly the degree of arm abduction, may influence the spread of local anesthetic and the characteristics of the block. However, the optimal arm abduction angle during this procedure remains unclear.

This prospective randomized controlled trial aims to investigate the effect of two different arm abduction angles (90° and 120°) on block onset time and block success in patients undergoing hand, wrist, and forearm surgery under ultrasound-guided costoclavicular brachial plexus block.

Patients will be randomly assigned to one of two groups according to the degree of arm abduction. The primary outcome is block onset time. Secondary outcomes include block success, sensory and motor block characteristics, perfusion index changes, hemodynamic parameters, readiness for surgery at 15 and 20 minutes, block performance time, need for additional anesthesia, postoperative neurological evaluation at 4 and 24 hours, complications, and patient satisfaction.

The findings of this study are expected to provide evidence on optimal patient positioning to improve the effectiveness and reliability of ultrasound-guided costoclavicular brachial plexus block.

Studienübersicht

Detaillierte Beschreibung

The costoclavicular approach is a recently described infraclavicular technique for brachial plexus block that provides reliable anesthesia for upper extremity surgeries. Due to the compact arrangement of the cords in the costoclavicular space, this technique has gained popularity for its high success rates and consistent anatomy. However, procedural factors such as patient positioning may influence the distribution of local anesthetic and the effectiveness of the block.

Arm abduction is known to alter the anatomical relationships within the infraclavicular region, potentially affecting needle visualization, spread of local anesthetic, and block characteristics. Despite its clinical relevance, there is limited evidence regarding the optimal degree of arm abduction during ultrasound-guided costoclavicular brachial plexus block.

This prospective randomized controlled study aims to compare two different arm abduction angles 90° and 120° in patients undergoing elective hand, wrist, and forearm surgery. After obtaining written informed consent, eligible patients will be randomly assigned into two groups according to the degree of arm abduction.

All procedures will be performed under ultrasound guidance using a standardized technique. The local anesthetic will be administered in the costoclavicular space, and block characteristics will be assessed systematically. The primary outcome is block onset time, defined as the time from completion of local anesthetic injection to the achievement of adequate sensory block for surgery.

Secondary outcomes include block success, sensory and motor block scores, perfusion index measurements, hemodynamic parameters, readiness for surgery at 15 and 20 minutes, block performance time, need for additional anesthesia or conversion to general anesthesia, early complications, postoperative neurological evaluation at 4 and 24 hours, and patient satisfaction assessed using a Likert scale.

The results of this study are expected to provide valuable evidence regarding optimal patient positioning and contribute to improving the clinical effectiveness and reliability of ultrasound-guided costoclavicular brachial plexus block.

Studientyp

Interventionell

Einschreibung (Geschätzt)

106

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

  • Name: Reyhan POLAT, Professor
  • Telefonnummer: +90 532 673 43 10
  • E-Mail: reyhanp9@gmail.com

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Inclusion Criteria:

  • Patients aged between 18 and 80 years.
  • Patients scheduled for elective upper extremity surgery (hand, wrist, forearm).
  • Patients classified as ASA I-III.
  • Patients who provide informed consent after being informed about the study.

Exclusion Criteria:

  • History of previous surgery, scar tissue, tumor, or trauma that may alter brachial plexus anatomy.
  • Presence of infection, hematoma, severe edema, burn, or open wound at the block application site.
  • Known allergy to local anesthetics or other medications used in the study.
  • Coagulopathy, use of anticoagulants, or platelet count < 100,000/mm³.
  • History of peripheral neuropathy, neurological deficit, cervical radiculopathy, or CRPS.
  • Pregnancy or breastfeeding.
  • Patients with BMI < 18 kg/m².
  • Patients with BMI > 35 kg/m².
  • Severe cardiac, pulmonary, renal, or hepatic failure.
  • Mental retardation, communication difficulties, or lack of cooperation.
  • Deformity, amputation, or large mass in the surgical extremity that may interfere with sensorimotor assessment.
  • Preoperative significant sensory loss, motor weakness, or signs of neurological disease.
  • Severe anemia (Hb < 9 g/dL) or polycythemia (Hb > 18 g/dL).
  • Psychiatric disorders, substance abuse, or any condition that may interfere with study compliance.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Screening
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 90° Arm Abduction
Patients receive ultrasound-guided costoclavicular brachial plexus block with the arm positioned at 90° abduction.
Ultra-sound Guided costoclavicular brachial plexus block performed for upper extremity surgery using a standard local anesthetic technique
Experimental: 120° Arm Abduction
Patients receive ultrasound-guided costoclavicular brachial plexus block with the arm positioned at 120° abduction.
Ultra-sound Guided costoclavicular brachial plexus block performed for upper extremity surgery using a standard local anesthetic technique

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Block Onset Time
Zeitfenster: Up to 30 minutes after block performance
Time from completion of local anesthetic injection to achievement of adequate sensory block sufficient for surgery, assessed by pinprick test.
Up to 30 minutes after block performance

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Block Success
Zeitfenster: İntraoperative period
Successful completion of surgery without the need for additional anesthesia.
İntraoperative period
Sensory Block Score
Zeitfenster: Baseline and at 5-minute intervals up to 20 minutes after block performance.
Sensory block was assessed using a 3-point pinprick scale ( 0= normal sensation, 1= loss of pinprick sensation, 2= complete sensory block).
Baseline and at 5-minute intervals up to 20 minutes after block performance.
Motor Block Score
Zeitfenster: Baseline and at 5-minute intervals up to 30 minutes after block performance.
Motor block was assessed using a 3-point motor scale (0= normal motor function, 1= reduced motor strength, 20 complete motor block).
Baseline and at 5-minute intervals up to 30 minutes after block performance.
Perfusion Index
Zeitfenster: Baseline and at 5,10,15 and 20 minutes after block performance.
Perfusion index values measured using a Masimo pulse oximeter probe placed on the blocked upper extremity.
Baseline and at 5,10,15 and 20 minutes after block performance.
Readiness for Surgery
Zeitfenster: 15 minutes after block
Proportion of patients ready for surgery at 15 and 20 minutes.
15 minutes after block
Readiness for Surgery
Zeitfenster: 20 minutes after block
Proportion of patients ready for surgery at 15 and 20 minutes
20 minutes after block
Block Performance Time
Zeitfenster: During procedure ( min )
Time required to perform the block.
During procedure ( min )
Need for Additional Anesthesia
Zeitfenster: Intraoperative period
Requirement for supplemental anesthesia or conversion to general anesthesia.
Intraoperative period
Complications
Zeitfenster: Up to 24 hours
Early complications related to block
Up to 24 hours
Postoperative Sensory and Motor Function Assessment
Zeitfenster: 4 hours after surgery
Postoperative neurological evaluation including sensory and motor function examination of the blocked upper extremity to assess for neurological complications.
4 hours after surgery
Postoperative Sensory and Motor Function Assessment
Zeitfenster: 24 hours after surgery
Postoperative neurological evaluation including sensory and motor function examination of the blocked upper extremity to assess for neurological complications.
24 hours after surgery
Patient Satisfaction
Zeitfenster: At the end of the surgery and 24 hours postoperatively
Patient satisfaction assessed using a 5-point Likert scale, where 1 indicates very dissatisfied and 5 indicates very satisfied.
At the end of the surgery and 24 hours postoperatively
Hemodynamic Parametres
Zeitfenster: Baseline and at 5,10,15 and 20minutes after block performance
Heart rate
Baseline and at 5,10,15 and 20minutes after block performance
Systolic Blood Pressure
Zeitfenster: Baseline and at 5,10,15 and 20 minutes after block performance.
Systolic blood pressure values measured during and after block performance.
Baseline and at 5,10,15 and 20 minutes after block performance.
Diastolic Blood Pressure
Zeitfenster: Baseline and at 5,10,15 and 20 minutes after block performance.
Diastolic blood pressure values measured during and after block performance.
Baseline and at 5,10,15 and 20 minutes after block performance.
Mean Arterial Pressure
Zeitfenster: Baseline and at 5,10,15 and 20 minutes after block performance.
Mean arterial pressure values measured during and after block performance.
Baseline and at 5,10,15 and 20 minutes after block performance.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Ermittler

  • Studienleiter: Reyhan Polat, Professor, Ankara Etlik City Hospital

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

15. Mai 2026

Primärer Abschluss (Geschätzt)

15. Juli 2026

Studienabschluss (Geschätzt)

27. August 2026

Studienanmeldedaten

Zuerst eingereicht

7. April 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

8. Mai 2026

Zuerst gepostet (Tatsächlich)

14. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

9. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

6. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

  • AEŞH-EK-2026-07

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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