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Completed

NCT Number: NCT05260736

Comparison of Costoclavicular and Paracoracoid Approaches to Infraclavicular Brachial Plexus Blocks

Infraclavicular block has taken its place in the literature as a proven technique in the anesthetic management of upper extremity surgeries. Compared to general anesthesia; The prominent advantages of regional anesthesia are that it provides longer perioperative pain control, reduces the incidence of postoperative nausea and vomiting, reduces opioid consumption and reduces the cost of hospitalization. The widespread use of ultrasonography (USG) in the last two decades has facilitated the application of the method and allowed the investigation of different injection methods.

Regional blocks are planned according to the surgery to be performed. For anesthesia of arm, forearm and hand operations; brachial plexus can be blocked in the axillary, infraclavicular, supraclavicular or interscalene region. The infraclavicular technique, on the other hand, is roughly divided into three types: costoclavicular lateral, costoclavicular medial and paracoracoid (Lateral sagittal). The image obtained by placing the ultrasonography probe in the relevant anatomical region serves as a guide for the orientation of the peripheral block needle and performing the intervention by observing the vascular structures in the existing region provides a great advantage in terms of patient safety.

In this study, we aimed to examine 3 different infraclavicular block methods; lateral costoclavicular, medial costoclavicular and lateral sagittal (Paracoracoid) approach, in terms of ease of application and motor/sensory block efficiency. Our hypothesis is that the sensory block will begin in a shorter time with costoclavicular methods compared to the lateral sagittal method. We are also planning to compare performance difficulties (needle maneuver numbers, subjective block exertion, block performance time etc.) for each type of intervention.

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Key information

Conditions

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Meltem Savran Karadeniz

Istanbul, Fatih, 34000, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients scheduled for elective upper extremity surgeries (Arm, upper-arm and hand)

Exclusion criteria

  • Patients with bleeding diathesis Presence of infection on the intervention site Patients requiring continous anticoagulation therapy due to the existing comorbidities Patients with history of local anesthetic allergy Pregnant patients

Treatment and study plan

Infraclavicular brachial plexus block

Procedure

Named after the anatomical site; patients will be applied infraclavicular brachial plexus block with costoclavicular lateral, costoclavicular medial or lateral sagittal approach.

Primary outcomes

  1. Sensory block onset time

    Time frame: Up to 45 minutes.

    Separately evaluated sensorial examination for four nerves (n. medianus, n. radialis, n. ulnaris, n. musculocutaneus), a total number of 6 points is accepted as "settled sensory block". 0= absent sensory block (feels pain), 1= partial sensory block (feels touch), 2= complete sensory block (no sense). Patients will be evaluated every 5 minutes after intervention.

Secondary outcomes

  1. Ideal USG guided brachial plexus cords visualization / needle pathway planning time

    Time frame: Up to 15 minutes

    Practitioner's ideal image acquisition time

  2. Needle tip and shaft imaging visualization difficulty

    Time frame: Up to 15 minutes

    Likert Scale: 1-5 (1:very hard; 5: very easy)

  3. Requirement of additional maneuver due to insufficient local anesthetic distribution

    Time frame: Up to 15 minutes

    Extra needle redirection to cover neural structure

  4. Total procedure difficulty according to anesthesiologist

    Time frame: Up to 15 minutes

    Likert Scale: 1-5 (1:Very hard; 5: Very easy)

  5. Patient number requiring rescue analgesics

    Time frame: Intraoperative 2-4 hours

    If a ≥ 20% increase above preinduction values in MAP or HR was observed during the perioperative period, additional fentanyl dose (1 μg/kg) was applied intravenously

  6. Motor blockade onset time

    Time frame: Up to 45 minutes

    Separately evaluated motor examination for four nerves (n. medianus, n. radialis, n. ulnaris, n. musculocutaneus), a total number of 6 points is accepted as "settled motor block". 0= absent motor block (Full movement), 1= partial motor block (free movement only), 2= complete motor block (no movement). Patients will be evaluated every 5 minutes after intervention.

  7. Time to postoperative first pain

    Time frame: Up to 24 hours

    Time to first intravenous analgesic administration which is requested by the patient

  8. Patient number requiring postoperative additional analgesic

    Time frame: Up to 24 hours

    Number of patients who require paracetamol (15 mg/kg) and tramadol (1mg/kg) IV

  9. Complications / Side effects

    Time frame: Up to 24 hours

    Possible complications related to infraclavicular block (such as vascular puncture, hematoma, pneumothorax, diaphragma palsy...)

  10. Patient satisfaction

    Time frame: Up to 24 hours

    Satisfaction score: 0: very unsatisfied 3: very satisfied

  11. Surgeon satisfaction

    Time frame: Up to 24 hours

    Satisfaction score: 0: very unsatisfied, 3: very satisfied

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Official study title

Comparison of Costoclavicular Lateral, Costoclavicular Medial and Lateral Sagittal Approaches to Infraclavicular Brachial Plexus Block in Upper Extremity Surgery

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 2, 2022
Registry last updated
May 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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