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Clinical Trials/NCT04356521
NCT04356521CompletedNot Applicable

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

Ondokuz Mayıs University1 site in 1 country109 target enrollmentStarted: May 1, 2020Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
109
Locations
1
Primary Endpoint
Start time of the nervous block

Study Overview

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.

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Group LS

Active Comparator

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

Intervention: Lateral Sagittal Approach (Procedure)

Group CC

Active Comparator

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

Intervention: Costoclavicular Approach (Procedure)

Outcomes

Primary Outcomes

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.

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).

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.

Secondary Outcomes

  • Time of sensory block(Postoperative Day 1)
  • Time of first analgesic request(Postoperative Day 1)
  • Surgeon Satisfaction(Postoperative Day 1)
  • Time of motor block(Postoperative Day 1)
  • Number of needle redirections(During the block procedure)
  • Number of patients who required a rescue block(45 minutes after the block procedure)
  • Patient Satisfaction(Postoperative Day 1)
  • Number of needle attempts(During the block procedure)

Investigators

Sponsor
Ondokuz Mayıs University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

BURHAN DOST

Assistant Professor

Ondokuz Mayıs University

Study Sites (1)

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