Lateral Sagittal vs Costoclavicular Approach for Ultrasound-Guided Infraclavicular Block

Anesthesia, Local Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04356521
• Other study ID #: CC0255
• Status: Completed
• Phase: N/A
• Start date: May 1, 2020
• Est. completion date: October 20, 2020

Study information

• Verified date: October 2020
• Source: Ondokuz Mayis University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: October 20, 2020
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia, Local
• Brachial Plexus Block
• Nerve Block

Intervention

Procedure:
• Lateral Sagittal 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).
• Costoclavicular 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.

Locations

Country	Name	City	State
Turkey	Ondokuz Mayis University	Samsun	Atakum

Sponsors (1)

Lead Sponsor	Collaborator
Ondokuz Mayis University

Country where clinical trial is conducted

Turkey, 

References & Publications (8)

Kavrut Ozturk N, Kavakli AS. Comparison of the coracoid and retroclavicular approaches for ultrasound-guided infraclavicular brachial plexus block. J Anesth. 2017 Aug;31(4):572-578. doi: 10.1007/s00540-017-2359-6. Epub 2017 Apr 18. — View Citation

Layera S, Aliste J, Bravo D, Fernández D, García A, Finlayson RJ, Tran DQ. Single- versus double-injection costoclavicular block: a randomized comparison. Reg Anesth Pain Med. 2020 Mar;45(3):209-213. doi: 10.1136/rapm-2019-101167. Epub 2020 Jan 14. — View Citation

Leurcharusmee P, Elgueta MF, Tiyaprasertkul W, Sotthisopha T, Samerchua A, Gordon A, Aliste J, Finlayson RJ, Tran DQH. A randomized comparison between costoclavicular and paracoracoid ultrasound-guided infraclavicular block for upper limb surgery. Can J Anaesth. 2017 Jun;64(6):617-625. doi: 10.1007/s12630-017-0842-z. Epub 2017 Feb 15. — View Citation

Mistry T, Balavenkatasubhramanian J, Natarajan V, Kuppusamy E. Ultrasound-guided bilateral costoclavicular brachial plexus blocks for single-stage bilateral upper limb surgeries: Abstain or indulge. J Anaesthesiol Clin Pharmacol. 2019 Oct-Dec;35(4):556-557. doi: 10.4103/joacp.JOACP_222_18. — View Citation

Monzó E, Hadzic A. Costoclavicular approach to the brachial plexus block: simple or double injection? Reg Anesth Pain Med. 2019 Sep 29. pii: rapm-2019-100852. doi: 10.1136/rapm-2019-100852. [Epub ahead of print] — View Citation

Oh C, Noh C, Eom H, Lee S, Park S, Lee S, Shin YS, Ko Y, Chung W, Hong B. Costoclavicular brachial plexus block reduces hemidiaphragmatic paralysis more than supraclavicular brachial plexus block: retrospective, propensity score matched cohort study. Korean J Pain. 2020 Apr 1;33(2):144-152. doi: 10.3344/kjp.2020.33.2.144. — View Citation

Silva GR, Borges DG, Lopes IF, Ruzi RA, Costa PRRM, Mandim BLDS. [Ultrasound-guided costoclavicular block as an alternative for upper limb anesthesia in obese patients]. Rev Bras Anestesiol. 2019 Sep - Oct;69(5):510-513. doi: 10.1016/j.bjan.2019.01.004. Epub 2019 Sep 10. Portuguese. — View Citation

Songthamwat B, Karmakar MK, Li JW, Samy W, Mok LYH. Ultrasound-Guided Infraclavicular Brachial Plexus Block: Prospective Randomized Comparison of the Lateral Sagittal and Costoclavicular Approach. Reg Anesth Pain Med. 2018 Nov;43(8):825-831. doi: 10.1097/AAP.0000000000000822. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	During the block procedure
Primary	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).	45 minutes after the block procedure
Primary	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.	45 minutes after the block procedure
Secondary	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.	Postoperative Day 1
Secondary	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).	Postoperative Day 1
Secondary	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.	Postoperative Day 1
Secondary	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.	Postoperative Day 1
Secondary	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.	During the block procedure
Secondary	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.	During the block procedure
Secondary	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.	45 minutes after the block procedure
Secondary	Time of first analgesic request	Time at which the first analgesic is requested.	Postoperative Day 1