Clinical trial

Comparison of Different Approaches for Supraclavicular Block and Their Effects on Diaphragm Muscle Function Evaluated With Diaphragm Thickening Fraction

Name
cagritez
Description
Brachial plexus blocks used for anesthesia in upper extremity operations can be performed with interscalene, axillary, supraclavicular and infraclavicular approaches. Plexus blockage can be performed under the guidance of needle nerve stimulation, artery palpation or ultrasonography (USG). Nowadays, the simultaneous use of USG during the block allows the protection of structures such as nerves, pleura and vessels, and allows practitioners to see the needle and the spread of local anesthetic during the injection. Although supraclavicular block seems to be advantageous because the brachial plexus is more compact and superficial in this region, it has a disadvantage of being close to the pleura. (Increased risk of pneumothorax) With the use of USG, this risk has decreased and the supraclavicular block has become an alternative to infraclavicular block, which is widely used in upper extremity surgery. Due to the compact structure of the brachial plexus trunk at the first rib level, the application of the block is easier and the block formation is faster due to the peripheral spread of the local anesthetic. With the spread of local anesthetic to C3-C5 nerve roots in the brachial plexus, paralysis can be seen in the ipsilateral phrenic nerve up to 67%. Patients who will be operated on, especially in patients with respiratory distress, may experience respiratory distress due to the dysfunction of that side diaphragm muscle. With the help of ultrasound, the inspiratory and end-expiratory thickness of the diaphragm is measured with the Diaphragm Thickness Index (DTI), which is a new and effective method used as a mechanical ventilator weaning index in intensive care units. With this method, we can examine the effect of phrenic nerve block on diaphragm muscle due to local anesthesia in the acute period. DTI is calculated as a percentage from the following formula: (Max thickness at the end of inspiration - Max thickness at the end of the expiration) / Max thickness at the end of the expiration. By comparing 3 different approaches used in supraclavicular block, we aimed to investigate the most appropriate block approach in terms of effectiveness, speed, complication rate, effects on diaphragm and 6 months effects.
Trial arms
Trial start
2021-02-16
Estimated PCD
2021-08-15
Trial end
2022-03-02
Status
Completed
Phase
Early phase I
Treatment
Bupivacaine HCl 0.5% Injectable Solution
20 ml of bupivacaine(Buvicaine HCl %0.5) and prilocaine(Priloc HCl %2) 1:1 mixture will be prepared in a way that there will be 5mcg adrenaline per ml.(9ml bupivacaine, 9ml prilocaine and 2ml saline with 50 mcg adrenaline per ml)
Arms:
corner pocket, corner+intracluster, multi
Other names:
buvicaine %0.5,
Prilocaine HCl % 2 injectable solution
20 ml of bupivacaine(Buvicaine HCl %0.5) and prilocaine(Priloc HCl %2) 1:1 mixture will be prepared in a way that there will be 5mcg adrenaline per ml.(9ml bupivacaine, 9ml prilocaine and 2ml saline with 50 mcg adrenaline per ml)
Arms:
corner pocket, corner+intracluster, multi
Other names:
priloc %2
adrenaline amp 0.5mg
20 ml of bupivacaine(Buvicaine HCl %0.5) and prilocaine(Priloc HCl %2) 1:1 mixture will be prepared in a way that there will be 5mcg adrenaline per ml.(9ml bupivacaine, 9ml prilocaine and 2ml saline with 50 mcg adrenaline per ml)
Arms:
corner pocket, corner+intracluster, multi
Other names:
adrenalin codex 0.5mg/1ml injectable solution
Ultrasound Guided Supraclavicular Block Corner pocket approach
The blocks will be performed by an experienced anesthesiologist with a USG guidance. Local anesthetic mixture will be given to the corner pocket - where the artery and the first rib intersect in the sonoanatomical image.
Arms:
corner pocket
Ultrasound Guided Supraclavicular Block Corner pocket + intracluster approach
The blocks will be performed by an experienced anesthesiologist with a USG guidance .10 ml of the local anesthetic mixture will be given to the described corner pack and the remaining 10 ml into the largest nerve cluster (Intracluster injection).
Arms:
corner+intracluster
Ultrasound Guided Supraclavicular Block multi approach
The blocks will be performed by an experienced anesthesiologist with a USG guidance Local anesthetic mixture will be administered by multi injection method between the nerve groups seen in the sonoanatomical image.
Arms:
multi
diagraphma muscle evaluation with ultrasound
All patients will be evaluated with USG in a head-up position facing the side to be operated before and 30 minutes after the block is performed. The probe will be placed perpendicular to the chest wall, in the eighth or ninth intercostal space, between the anterior axillary and midaxillary lines, 0.5 to 2 cm below the costophrenic sinus.
Arms:
corner pocket, corner+intracluster, multi
Size
90
Primary endpoint
Comparison of Three Different Approach for Supraclavicular Blocks Effects on Diaphragm Thickening Fraction
Comparison of Diaphragm Thickening Fraction will be evaluated 30 minutes after the block is performed.
Eligibility criteria
Inclusion Criteria: * Patients who are scheduled scheduled for hand, wrist, forearm, arm surgery * Patients who has informed consent for study * Patients with American Society of Anesthesiologists Physical Status Classification(ASA) I,II and III Exclusion Criteria: * Patient's refusal to participate * Patients under 18 years of age * Patients with known local anesthetic allergy * Patients with Body mass index\> 35 * Patients diagnosed sepsis and bacteriemia, * Skin infection at the injection site, * History of coagulopathy or anticoagulant therapy * Patients with uncontrolled diabetes, * Uncoordinated patients, * Psychological and emotional lability, * Patients with anatomical disorders at application points * Pregnant patients
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Three groups involved. 3 different approaches of supraclavicular block will be compared. Approaches share the same probe position and needle entry point but differ in where the local anesthetic is given.\n\nGroup 1: Local anesthetic mixture will be given to the corner pocket - where the artery and the first rib intersect in the sonoanatomical image.\n\nGroup 2: 10 ml of the local anesthetic mixture will be given to the described corner pack and the remaining 10 ml into the largest nerve cluster (Intracluster injection).\n\nGroup 3: Local anesthetic mixture will be administered by multi injection method between the nerve groups seen in the sonoanatomical image.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': "The participant will not know which group he or she is in. The diaphragm thickening fraction and evaluations (outcomes) will be made by another experienced anesthesiologist, double-blindness will be achieved by being blind to the patient's group.\n\nBlock evaluation and measurements will be made by a different experienced anesthesiologist .", 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 90, 'type': 'ACTUAL'}}
Updated at
2023-06-13

1 organization

3 products

6 indications

Indication
Complications
Indication
Nerve Block
Product
Adrenaline