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NCT Number: NCT04356521

Lateral Sagittal vs Costoclavicular Approach for Ultrasound-Guided Infraclavicular Block

An ultrasound-guided infraclavicular block performed with the costoclavicular (CC) approach and the lateral sagittal (LS) approach will be compared in patients scheduled for forearm and hand surgery.

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Key information

Conditions

Anesthesia, Local Brachial Plexus Block Nerve Block

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ondokuz Mayis University

Samsun, Atakum, 55139, Turkey (Türkiye)

About this study

The CC approach is a recently introduced infraclavicular approach that targets three cords (medial, lateral and posterior) located lateral to the axillary artery in the costoclavicular space. Cords in this space are located more superficially than with the classical approach at the lateral infraclavicular fossa and are clustered but maintain a consistent anatomical relationship with each other.

Patients will be divided into two groups:

Group LS: Ultrasound-guided infraclavicular block - lateral sagittal approach (20 ml 0.5% bupivacaine)

Group CC: Ultrasound-guided infraclavicular block - costoclavicular approach (20 ml 0.5% bupivacaine)

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age 18 years to 65 years
  • Patients scheduled for elective forearm and hand surgeries
  • Patients with American Society of Anesthesiologists (ASA) 1-3

Exclusion criteria

  • Patients not consenting/unwilling to participate
  • Age <18 years or >65 years
  • Patients with ASA 4
  • Obesity (BMI >30 kg/m2)
  • Regional anesthesia contraindicated (thrombocytopenia, infection at injection site)
  • Severe renal, cardiac, or hepatic disease
  • History of hypersensitivity or allergy to local anesthetics
  • History of opioid or steroid use for more than 4 weeks
  • History of psychiatric disorders
  • Analgesic treatment in the last 48 hours preoperatively
  • Operations lasting less than 60 minutes and more than 180 minutes
  • Patients who converted to general anesthesia

Treatment and study plan

Lateral Sagittal Approach

Procedure

The US probe will be located medial to the coracoid process in the sagittal plane in the infraclavicular region, and then three cords of the brachial plexus will be viewed. Using the in-plane technique, bupivacaine 0.5% will be administered around the posterior cord (7ml), lateral cord (7ml), and medial cord (6ml).

Other names: Infraclavicular Block - Lateral Sagittal Approach

Costoclavicular Approach

Procedure

The US probe will be placed parallel to the clavicle in the midclavicular area and tilted toward the cephalad and the axillary artery, and three cords will be viewed. A needle will be forwarded from lateral to medial with the in-plane technique, and 20 ml of bupivacaine 0.5% will be administered at the center of the three cords.

Other names: Infraclavicular Block - Costoclavicular Approach

Primary outcomes

  1. Performance time of the operator

    Time frame: During the block procedure

    Time elapsed from when the needle enters the skin after an optimal view is obtained on ultrasound until the block needle exits the skin after the procedure is completed.

  2. Duration of start of motor block

    Time frame: 45 minutes after the block procedure

    Time from when a Lovett score of 5 is seen in at least 1 of 3 cords in the patient extremity on which the operation is being performed, following local anesthetic injection.

    Lovett rating scale: 6 = normal muscle strength, 5 = slightly decreased muscle strength, 4 = significantly decreased muscle strength, 3 = slight loss of movement, 2 = significant loss of movement, 1 = near total loss of movement, and 0 = total paralysis.

    Motor block cord myotomes will be evaluated as medial cord (thumb adduction = ulnar nerve), lateral cord (elbow flexion = mucocutaneous nerve), and posterior cord (wrist extension = radial nerve).

  3. Start time of the nervous block

    Time frame: 45 minutes after the block procedure

    Time from the local injection to when a pin-prick test yields no response in at least 1 of 3 cords in the extremity on which the operation is being performed.

Secondary outcomes

  1. Time of sensory block

    Time frame: Postoperative Day 1

    Time when the patient describes pain or when the pin-prick test yields a positive response in the extremity on which the operation is performed.

  2. Time of motor block

    Time frame: Postoperative Day 1

    Time when Lovett score is 2 at any of the 3 dermatomes of the extremity on which the operation is being performed.

    Lovett rating scale 6 = normal muscle strength, 5 = slightly decreased muscle strength, 4 = significantly decreased muscle strength, 3 = slight loss of movement, 2 = significant loss of movement, 1 = near total loss of movement, and 0= total paralysis.

    Motor block cord myotomes will be evaluated as medial cord (thumb adduction=ulnar nerve), lateral cord (elbow flexion= mucocutaneous nerve), and posterior cord (wrist extension=radial nerve).

  3. Patient Satisfaction

    Time frame: Postoperative Day 1

    The discomfort produced by the procedure will be evaluated using the visual rating scale (VRS) at the end of the operation day.

    VRS: 0-100, 0 = no discomfort at all, 100 = excessive discomfort.

  4. Surgeon Satisfaction

    Time frame: Postoperative Day 1

    Surgeon satisfaction will be evaluated at the end of the operation day using the VRS.

    VRS: 0-100, 0 = no discomfort at all, 100 = excessive discomfort.

  5. Number of needle redirections

    Time frame: During the block procedure

    Number of needle redirections until target area is reached: number of attempts to withdraw and redirect the needle without total withdrawal from the skin.

  6. Number of needle attempts

    Time frame: During the block procedure

    Number of needle attempts required until target area is reached: number of withdrawals and redirections of the needle with total withdrawal from the skin.

  7. Number of patients who required a rescue block

    Time frame: 45 minutes after the block procedure

    Patients subjected to an additional rescue block due to positivity in a pin-prick test at a sensorial examination 45 minutes after the block procedure; these patients will be recorded.

  8. Time of first analgesic request

    Time frame: Postoperative Day 1

    Time at which the first analgesic is requested.

Sponsors and collaborators

Lead sponsor

Ondokuz Mayıs University

Other

Registry information

Official study title

Lateral Sagittal Versus Costoclavicular Approach for Ultrasound-Guided Infraclavicular Brachial Plexus Block: Comparison of Block Dynamics and Patient Comfort

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 22, 2020
Registry last updated
Oct 26, 2020

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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