Comparison of Costoclavicular and Paracoracoid Approaches to Infraclavicular Brachial Plexus Blocks

Not Applicable

Completed

• Conditions: Anesthesia
• Interventions: Procedure: Infraclavicular brachial plexus block

• Registration Number: NCT05260736
• Lead Sponsor: Istanbul University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-20
• Study First Submitted QC: 2022-02-20
• Study First Posted: 2022-03-02
• Study Start: 2022-06-01
• Status Verified: 2023-05
• Primary Completion: 2023-05-01
• Study Completion: 2023-05-02
• Last Update Submitted: 2023-05-04
• Last Update Posted: 2023-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group Lateral Sagittal (LS)	Infraclavicular brachial plexus block	Patients anesthetized with lateral sagittal infraclavicular brachial plexus block.
Group Costoclavicular Lateral (CL)	Infraclavicular brachial plexus block	Patients anesthetized with costoclavicular lateral infraclavicular brachial plexus block.
Group Costoclavicular Medial (CM)	Infraclavicular brachial plexus block	Patients anesthetized with costoclavicular medial infraclavicular brachial plexus block.

Primary Outcome Measures

Name	Time	Method
Sensory block onset time	Up to 45 minutes.	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.

Secondary Outcome Measures

Name	Time	Method
Time to postoperative first pain	Up to 24 hours	Time to first intravenous analgesic administration which is requested by the patient
Complications / Side effects	Up to 24 hours	Possible complications related to infraclavicular block (such as vascular puncture, hematoma, pneumothorax, diaphragma palsy...)
Surgeon satisfaction	Up to 24 hours	Satisfaction score: 0: very unsatisfied, 3: very satisfied
Needle tip and shaft imaging visualization difficulty	Up to 15 minutes	Likert Scale: 1-5 (1:very hard; 5: very easy)
Requirement of additional maneuver due to insufficient local anesthetic distribution	Up to 15 minutes	Extra needle redirection to cover neural structure
Total procedure difficulty according to anesthesiologist	Up to 15 minutes	Likert Scale: 1-5 (1:Very hard; 5: Very easy)
Motor blockade onset time	Up to 45 minutes	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.
Patient number requiring postoperative additional analgesic	Up to 24 hours	Number of patients who require paracetamol (15 mg/kg) and tramadol (1mg/kg) IV
Patient satisfaction	Up to 24 hours	Satisfaction score: 0: very unsatisfied 3: very satisfied
Ideal USG guided brachial plexus cords visualization / needle pathway planning time	Up to 15 minutes	Practitioner's ideal image acquisition time
Patient number requiring rescue analgesics	Intraoperative 2-4 hours	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

Trial Locations

Locations (1)

Meltem Savran Karadeniz; 🇹🇷 Istanbul, Fatih, Turkey