Lateral Sagittal vs Costoclavicular Approach for Ultrasound-Guided Infraclavicular Block

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

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia, Local; Brachial Plexus Block; Nerve Block
• Intervention / Treatment: Procedure: Lateral Sagittal Approach; Procedure: Costoclavicular Approach

Detailed 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)

• Study Type: Interventional
• Enrollment (Actual): 109
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Atakum
    • Samsun, Atakum, Turkey, 55139
      • Ondokuz Mayis University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group LS; Ultrasound-guided infraclavicular block - lateral sagittal approach (20 ml 0.5% bupivacaine)	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).; Other Names: Infraclavicular Block - Lateral Sagittal Approach
Active Comparator: Group CC; Ultrasound-guided infraclavicular block - costoclavicular approach (20 ml 0.5% bupivacaine)	Procedure: 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.; Other Names: Infraclavicular Block - Costoclavicular Approach

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
Time of first analgesic request	Time at which the first analgesic is requested.	Postoperative Day 1

Collaborators and Investigators

• Sponsor: Ondokuz Mayıs University
• Investigators: Principal Investigator: BURHAN DOST, Ondokuz Mayıs University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• Layera S, Aliste J, Bravo D, Fernandez D, Garcia 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.
• 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. No abstract available.
• Monzo E, Hadzic A. Costoclavicular approach to the brachial plexus block: simple or double injection? Reg Anesth Pain Med. 2019 Sep 29:rapm-2019-100852. doi: 10.1136/rapm-2019-100852. Online ahead of print. No abstract available.
• 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]. Braz J Anesthesiol. 2019 Sep-Oct;69(5):510-513. doi: 10.1016/j.bjan.2019.01.004. Epub 2019 Sep 10.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2020
• Primary Completion (Actual): October 1, 2020
• Study Completion (Actual): October 20, 2020

Study Registration Dates

• First Submitted: April 19, 2020
• First Submitted That Met QC Criteria: April 21, 2020
• First Posted (Actual): April 22, 2020

Study Record Updates

• Last Update Posted (Actual): October 26, 2020
• Last Update Submitted That Met QC Criteria: October 22, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Ultrasound; Upper Extremity; Anesthesia, Conduction; Infraclavicular; Brachial Plexus Block/methods; Costoclavicular approach; Lateral Sagittal approach
• Other Study ID Numbers: CC0255

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No