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Lateral Sagittal vs Costoclavicular Approach for Ultrasound-Guided Infraclavicular Block

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04356521
Recruitment Status : Completed
First Posted : April 22, 2020
Last Update Posted : October 26, 2020
Sponsor:
Information provided by (Responsible Party):
BURHAN DOST, Ondokuz Mayıs University

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.

Condition or disease Intervention/treatment Phase
Anesthesia, Local Nerve Block Brachial Plexus Block Procedure: Lateral Sagittal Approach Procedure: Costoclavicular Approach Not Applicable

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)

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 109 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Lateral Sagittal Versus Costoclavicular Approach for Ultrasound-Guided Infraclavicular Brachial Plexus Block: Comparison of Block Dynamics and Patient Comfort
Actual Study Start Date : May 1, 2020
Actual Primary Completion Date : October 1, 2020
Actual Study Completion Date : October 20, 2020

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 Name: 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 Name: Infraclavicular Block - Costoclavicular Approach




Primary Outcome Measures :
  1. Performance time of the operator [ Time Frame: During the block procedure ]
    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.

  2. Duration of start of motor block [ Time Frame: 45 minutes after the block procedure ]

    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).


  3. Start time of the nervous block [ Time Frame: 45 minutes after the block procedure ]
    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.


Secondary Outcome Measures :
  1. Time of sensory block [ Time Frame: Postoperative Day 1 ]
    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.

  2. Time of motor block [ Time Frame: Postoperative Day 1 ]

    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).


  3. Patient Satisfaction [ Time Frame: Postoperative Day 1 ]

    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.


  4. Surgeon Satisfaction [ Time Frame: Postoperative Day 1 ]

    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.


  5. Number of needle redirections [ Time Frame: During the block procedure ]
    Number of needle redirections until target area is reached: number of attempts to withdraw and redirect the needle without total withdrawal from the skin.

  6. Number of needle attempts [ Time Frame: During the block procedure ]
    Number of needle attempts required until target area is reached: number of withdrawals and redirections of the needle with total withdrawal from the skin.

  7. Number of patients who required a rescue block [ Time Frame: 45 minutes after the block procedure ]
    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.

  8. Time of first analgesic request [ Time Frame: Postoperative Day 1 ]
    Time at which the first analgesic is requested.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04356521


Locations
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Turkey
Ondokuz Mayis University
Samsun, Atakum, Turkey, 55139
Sponsors and Collaborators
Ondokuz Mayıs University
Investigators
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Principal Investigator: BURHAN DOST Ondokuz Mayıs University
Publications:

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Responsible Party: BURHAN DOST, Assistant Professor, Ondokuz Mayıs University
ClinicalTrials.gov Identifier: NCT04356521    
Other Study ID Numbers: CC0255
First Posted: April 22, 2020    Key Record Dates
Last Update Posted: October 26, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by BURHAN DOST, Ondokuz Mayıs University:
Anesthesia, Conduction
Ultrasound
Brachial Plexus Block/methods
Infraclavicular
Costoclavicular approach
Lateral Sagittal approach
Upper Extremity