Comparison of Costoclavicular and Paracoracoid Approaches to Infraclavicular Brachial Plexus Blocks

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05260736
• Other study ID #: 2022/151
• Status: Completed
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: May 2, 2023

Study information

• Verified date: May 2023
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: May 2, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia

Intervention

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.

Locations

Country	Name	City	State
Turkey	Meltem Savran Karadeniz	Istanbul	Fatih

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

Outcome

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