Comparison of Costoclavicular and Paracoracoid Approaches to Infraclavicular Brachial Plexus Blocks

NCT05260736 | Completed

• 1 other identifier: 2022/151
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

Infraclavicular block has taken its place in the literature as a proven technique in the anesthetic management of upper extremity surgeries. Compared to general anesthesia; The prominent advantages of regional anesthesia are that it provides longer perioperative pain control, reduces the incidence of postoperative nausea and vomiting, reduces opioid consumption and reduces the cost of hospitalization. The widespread use of ultrasonography (USG) in the last two decades has facilitated the application of the method and allowed the investigation of different injection methods. Regional blocks are planned according to the surgery to be performed. For anesthesia of arm, forearm and hand operations; brachial plexus can be blocked in the axillary, infraclavicular, supraclavicular or interscalene region. The infraclavicular technique, on the other hand, is roughly divided into three types: costoclavicular lateral, costoclavicular medial and paracoracoid (Lateral sagittal). The image obtained by placing the ultrasonography probe in the relevant anatomical region serves as a guide for the orientation of the peripheral block needle and performing the intervention by observing the vascular structures in the existing region provides a great advantage in terms of patient safety. In this study, we aimed to examine 3 different infraclavicular block methods; lateral costoclavicular, medial costoclavicular and lateral sagittal (Paracoracoid) approach, in terms of ease of application and motor/sensory block efficiency. Our hypothesis is that the sensory block will begin in a shorter time with costoclavicular methods compared to the lateral sagittal method. We are also planning to compare performance difficulties (needle maneuver numbers, subjective block exertion, block performance time etc.) for each type of intervention.

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

• Sensory block onset time

  Separately evaluated sensorial examination for four nerves (n. medianus, n. radialis, n. ulnaris, n. musculocutaneus), a total number of 6 points is accepted as "settled sensory block". 0= absent sensory block (feels pain), 1= partial sensory block (feels touch), 2= complete sensory block (no sense). Patients will be evaluated every 5 minutes after intervention.

  Up to 45 minutes.

Secondary Outcomes (11)

• Ideal USG guided brachial plexus cords visualization / needle pathway planning time

  Up to 15 minutes

• Needle tip and shaft imaging visualization difficulty

  Up to 15 minutes

• Requirement of additional maneuver due to insufficient local anesthetic distribution

  Up to 15 minutes

• Total procedure difficulty according to anesthesiologist

  Up to 15 minutes

• Patient number requiring rescue analgesics

  Intraoperative 2-4 hours

Study Arms (3)

Group Costoclavicular Lateral (CL)

ACTIVE COMPARATOR

Patients anesthetized with costoclavicular lateral infraclavicular brachial plexus block.

Procedure: Infraclavicular brachial plexus block

Group Costoclavicular Medial (CM)

ACTIVE COMPARATOR

Patients anesthetized with costoclavicular medial infraclavicular brachial plexus block.

Procedure: Infraclavicular brachial plexus block

Group Lateral Sagittal (LS)

ACTIVE COMPARATOR

Patients anesthetized with lateral sagittal infraclavicular brachial plexus block.

Procedure: Infraclavicular brachial plexus block

Interventions

Infraclavicular brachial plexus block PROCEDURE

Named after the anatomical site; patients will be applied infraclavicular brachial plexus block with costoclavicular lateral, costoclavicular medial or lateral sagittal approach.

Group Costoclavicular Lateral (CL); Group Costoclavicular Medial (CM); Group Lateral Sagittal (LS)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled for elective upper extremity surgeries (Arm, upper-arm and hand)

You may not qualify if:

• Patients with bleeding diathesis Presence of infection on the intervention site Patients requiring continous anticoagulation therapy due to the existing comorbidities Patients with history of local anesthetic allergy Pregnant patients

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Meltem Savran Karadeniz

Istanbul, Fatih, 34000, Turkey (Türkiye)

Location

Related Publications (1)

• Bingul ES, Canbaz M, Guzel M, Salviz EA, Akalin BE, Berkoz O, Emre Demirel E, Sungur Z, Savran Karadeniz M. Comparing the clinical features of lateral and medial approaches of costoclavicular technique versus traditional lateral sagittal technique as infraclavicular brachial plexus block methods: a randomized controlled trial. BMC Anesthesiol. 2024 Jul 25;24(1):254. doi: 10.1186/s12871-024-02645-z.

  PMID: 39054425 DERIVED

Study Design

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

Model Details: Randomized, Double-Blind, Prospective, Interventional

Study Record Dates

• First Submitted: February 20, 2022
• First Posted: March 2, 2022
• Study Start: June 1, 2022
• Primary Completion: May 1, 2023
• Study Completion: May 2, 2023
• Last Updated: May 6, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)