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Anesthesia, LocalNCT04356521

Lateral Sagittal vs Costoclavicular Approach for Ultrasound-Guided Infraclavicular Block

A study testing Lateral Sagittal Approach and Costoclavicular Approach in people with Anesthesia, Local and Nerve Block, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
What is being tested?
Lateral Sagittal Approach and Costoclavicular Approach
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
109 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 May 2020to 20 Oct 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Ondokuz Mayis University

    Samsun, Atakum, 55139

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read the 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)

Being tested
Lateral Sagittal Approach, Costoclavicular Approach
Keywords
Anesthesia, Conduction, Ultrasound, Brachial Plexus Block/methods, Infraclavicular, Costoclavicular approach, Lateral Sagittal approach, Upper Extremity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lateral Sagittal ApproachProcedure or surgery

    Also called Infraclavicular Block - 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 ApproachProcedure or surgery

    Also called Infraclavicular Block - 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.

Study groups in NCT04356521
Study groupRoleWhat they receive
Group LSActive comparatorUltrasound-guided infraclavicular block - lateral sagittal approach (20 ml 0.5% bupivacaine)
Receives: Procedure: Lateral Sagittal Approach
Group CCActive comparatorUltrasound-guided infraclavicular block - costoclavicular approach (20 ml 0.5% bupivacaine)
Receives: Procedure: Costoclavicular Approach

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: During the block procedure

  2. 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).

    Measured: 45 minutes after the block procedure

  3. 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.

    Measured: 45 minutes after the block procedure

Secondary outcomes (8)

  1. 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.

    Measured: Postoperative Day 1

  2. 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).

    Measured: Postoperative Day 1

  3. 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.

    Measured: Postoperative Day 1

  4. 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.

    Measured: Postoperative Day 1

  5. 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.

    Measured: During the block procedure

  6. 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.

    Measured: During the block procedure

  7. 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.

    Measured: 45 minutes after the block procedure

  8. Time of first analgesic request

    Time at which the first analgesic is requested.

    Measured: Postoperative Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Apr 2020
  2. Study start1 May 2020
  3. Primary completion1 Oct 2020
  4. Study completion20 Oct 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
109 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04356521
Sponsor's protocol ID
CC0255
Status last verified
Oct 2020
First submitted
19 Apr 2020
Last updated
26 Oct 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

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.

    PubMed 28205117

  • 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.

    PubMed 29923950

  • 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.

    PubMed 28421316

  • 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.

    PubMed 32235015

  • 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.

    PubMed 31941792

  • 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.

    PubMed 31920246

  • 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.

    PubMed 31570494

  • 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.

    PubMed 31519300

Questions about this trial

What is this clinical trial studying?

A study testing Lateral Sagittal Approach and Costoclavicular Approach in people with Anesthesia, Local and Nerve Block, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Performance time of the operator (time frame: During the block procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04356521, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2020.

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