Lateral Sagittal vs Costoclavicular Approach for Ultrasound-Guided Infraclavicular Block

NCT04356521 | Completed

• 1 other identifier: CC0255
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anesthesia, Local; Nerve Block; Brachial Plexus Block

Keywords

Anesthesia, Conduction; Ultrasound; Brachial Plexus Block/methods; Infraclavicular; Costoclavicular approach; Lateral Sagittal approach; Upper Extremity

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (8)

• Time of sensory block

  Postoperative Day 1

• Time of motor block

  Postoperative Day 1

• Patient Satisfaction

  Postoperative Day 1

• Surgeon Satisfaction

  Postoperative Day 1

• Number of needle redirections

  During the block procedure

Study Arms (2)

Group LS

ACTIVE COMPARATOR

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

Procedure: Lateral Sagittal Approach

Group CC

ACTIVE COMPARATOR

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

Procedure: Costoclavicular Approach

Interventions

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).

Also known as: Infraclavicular Block - Lateral Sagittal Approach

Group LS

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.

Also known as: Infraclavicular Block - Costoclavicular Approach

Group CC

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

Study Sites (1)

Ondokuz Mayis University

Samsun, Atakum, 55139, Turkey (Türkiye)

Location

Related Publications (8)

• 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.

  PMID: 28205117 BACKGROUND

• 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.

  PMID: 29923950 BACKGROUND

• 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.

  PMID: 28421316 BACKGROUND

• 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.

  PMID: 32235015 BACKGROUND

• 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.

  PMID: 31941792 BACKGROUND

• 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.

  PMID: 31920246 BACKGROUND

• 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.

  PMID: 31570494 BACKGROUND

• 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.

  PMID: 31519300 BACKGROUND

Study Officials

• BURHAN DOST

  Ondokuz Mayıs University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 19, 2020
• First Posted: April 22, 2020
• Study Start: May 1, 2020
• Primary Completion: October 1, 2020
• Study Completion: October 20, 2020
• Last Updated: October 26, 2020

Record last verified: 2020-10

Locations

TU (1)