Comparison of Costoclavicular and Paracoracoid Approaches to Infraclavicular Brachial Plexus Blocks

Comparison of Costoclavicular Lateral, Costoclavicular Medial and Lateral Sagittal Approaches to Infraclavicular Brachial Plexus Block in Upper Extremity Surgery

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia
• Intervention / Treatment: Procedure: Infraclavicular brachial plexus block

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Fatih
    • Istanbul, Fatih, Turkey, 34000
      • Meltem Savran Karadeniz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group Costoclavicular Lateral (CL); Patients anesthetized with costoclavicular lateral infraclavicular brachial plexus block.	Procedure: Infraclavicular brachial plexus block; Named after the anatomical site; patients will be applied infraclavicular brachial plexus block with costoclavicular lateral, costoclavicular medial or lateral sagittal approach.
Active Comparator: Group Costoclavicular Medial (CM); Patients anesthetized with costoclavicular medial infraclavicular brachial plexus block.	Procedure: Infraclavicular brachial plexus block; Named after the anatomical site; patients will be applied infraclavicular brachial plexus block with costoclavicular lateral, costoclavicular medial or lateral sagittal approach.
Active Comparator: Group Lateral Sagittal (LS); Patients anesthetized with lateral sagittal infraclavicular brachial plexus block.	Procedure: Infraclavicular brachial plexus block; Named after the anatomical site; patients will be applied infraclavicular brachial plexus block with costoclavicular lateral, costoclavicular medial or lateral sagittal approach.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgeon satisfaction	Satisfaction score: 0: very unsatisfied, 3: very satisfied	Up to 24 hours
Ideal USG guided brachial plexus cords visualization / needle pathway planning time	Practitioner's ideal image acquisition time	Up to 15 minutes
Needle tip and shaft imaging visualization difficulty	Likert Scale: 1-5 (1:very hard; 5: very easy)	Up to 15 minutes
Requirement of additional maneuver due to insufficient local anesthetic distribution	Extra needle redirection to cover neural structure	Up to 15 minutes
Total procedure difficulty according to anesthesiologist	Likert Scale: 1-5 (1:Very hard; 5: Very easy)	Up to 15 minutes
Patient number requiring rescue analgesics	If a ≥ 20% increase above preinduction values in MAP or HR was observed during the perioperative period, additional fentanyl dose (1 μg/kg) was applied intravenously	Intraoperative 2-4 hours
Motor blockade onset time	Separately evaluated motor examination for four nerves (n. medianus, n. radialis, n. ulnaris, n. musculocutaneus), a total number of 6 points is accepted as "settled motor block". 0= absent motor block (Full movement), 1= partial motor block (free movement only), 2= complete motor block (no movement). Patients will be evaluated every 5 minutes after intervention.	Up to 45 minutes
Time to postoperative first pain	Time to first intravenous analgesic administration which is requested by the patient	Up to 24 hours
Patient number requiring postoperative additional analgesic	Number of patients who require paracetamol (15 mg/kg) and tramadol (1mg/kg) IV	Up to 24 hours
Complications / Side effects	Possible complications related to infraclavicular block (such as vascular puncture, hematoma, pneumothorax, diaphragma palsy...)	Up to 24 hours
Patient satisfaction	Satisfaction score: 0: very unsatisfied 3: very satisfied	Up to 24 hours

Collaborators and Investigators

• Sponsor: Istanbul University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Actual): May 1, 2023
• Study Completion (Actual): May 2, 2023

Study Registration Dates

• First Submitted: February 20, 2022
• First Submitted That Met QC Criteria: February 20, 2022
• First Posted (Actual): March 2, 2022

Study Record Updates

• Last Update Posted (Estimate): May 5, 2023
• Last Update Submitted That Met QC Criteria: May 4, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2022/151

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No