Clinical trial NCT05260736: Comparison of Costoclavicular and Paracoracoid Approaches to Infraclavicular Brachial Plexus Blocks
Official title: Comparison of Costoclavicular Lateral, Costoclavicular Medial and Lateral Sagittal Approaches to Infraclavicular Brachial Plexus Block in Upper Extremity Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2022-03-02
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, Double-Blind, Prospective, Interventional
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Sensory block onset time
timeFrame: Up to 45 minutes.
Secondary outcomes:
measure: Ideal USG guided brachial plexus cords visualization / needle pathway planning time
timeFrame: Up to 15 minutes
measure: Needle tip and shaft imaging visualization difficulty
timeFrame: Up to 15 minutes
measure: Requirement of additional maneuver due to insufficient local anesthetic distribution
timeFrame: Up to 15 minutes
measure: Total procedure difficulty according to anesthesiologist
timeFrame: Up to 15 minutes
measure: Patient number requiring rescue analgesics
timeFrame: Intraoperative 2-4 hours
measure: Motor blockade onset time
timeFrame: Up to 45 minutes
measure: Time to postoperative first pain
timeFrame: Up to 24 hours
measure: Patient number requiring postoperative additional analgesic
timeFrame: Up to 24 hours
measure: Complications / Side effects
timeFrame: Up to 24 hours
measure: Patient satisfaction
timeFrame: Up to 24 hours
measure: Surgeon satisfaction
timeFrame: Up to 24 hours
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Meltem Savran Karadeniz
state: Fatih
Study officials:
References: