An interventional study of Lateral Sagittal Approach and Costoclavicular Approach in Anesthesia, Local, Nerve Block and Brachial Plexus Block, sponsored by Ondokuz Mayıs University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-10-26.
Sponsored by Ondokuz Mayıs University · Not applicable, Interventional, and Treatment
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.
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)
Ondokuz Mayıs University is the lead sponsor of 262 studies on the registry; 68 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Ultrasound-guided infraclavicular block - lateral sagittal approach (20 ml 0.5% bupivacaine)
Procedure: Lateral Sagittal Approach
Ultrasound-guided infraclavicular block - costoclavicular approach (20 ml 0.5% bupivacaine)
Procedure: Costoclavicular Approach
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).
Also known as: Infraclavicular Block - Lateral Sagittal Approach
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.
Also known as: Infraclavicular Block - Costoclavicular Approach
Performance time of the operator
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.
Time frame: During the block procedure
Duration of start of motor block
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).
Time frame: 45 minutes after the block procedure
Start time of the nervous block
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.
Time frame: 45 minutes after the block procedure
Time of sensory block
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.
Time frame: Postoperative Day 1
Time of motor block
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).
Time frame: Postoperative Day 1
Patient Satisfaction
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.
Time frame: Postoperative Day 1
Surgeon Satisfaction
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.
Time frame: Postoperative Day 1
Number of needle redirections
Number of needle redirections until target area is reached: number of attempts to withdraw and redirect the needle without total withdrawal from the skin.
Time frame: During the block procedure
Number of needle attempts
Number of needle attempts required until target area is reached: number of withdrawals and redirections of the needle with total withdrawal from the skin.
Time frame: During the block procedure
Number of patients who required a rescue block
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.
Time frame: 45 minutes after the block procedure
Time of first analgesic request
Time at which the first analgesic is requested.
Time frame: Postoperative Day 1
This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Ondokuz Mayıs University