Comparison of Different Approaches for Supraclavicular Block and Their Effects on Diaphragm Muscle Function
Condition: Phrenic Nerve Paralysis; Diaphragm Sellae Meningioma; Complications; Respiratory Complication; Nerve Block; Brachial Plexus Block
MeSH terms: Meningioma; Paralysis
Study type: Interventional
Phase: Phase 4

Summary: 
      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.
    

Detailed description: 
      In this prospective randomized double-blind study, patients will be divided into 3 groups
      using a computer program.

      Standard monitoring (ECG, pulse oximetry, noninvasive blood pressure) will be applied to the
      patients who will then be taken to the block application room . After the peripheral vascular
      access is established on the hand that will not be operated on, premedication will be
      provided with 2 mg iv midazolam.

      The blocks will be performed by an experienced anesthesiologist with the USG guidance. Block
      evaluation and measurements will be made by a different experienced anesthesiologist. After
      the antisepsis of the area to be blocked, a 22G 50 mm stimulator needle will be used for the
      block. Intermittent negative aspiration will be performed during all procedures to detect
      possible vascular puncture. The local anesthetic mixture we routinely use in our clinic will
      be used. 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) The ultrasound probe will be placed
      on the clavicle, the supraclavicular block will be applied in the coronal oblique plane using
      the in-plane technique.

      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.

      Group 1: Local anesthetic mixture will be given to the corner pocket - where the artery and
      the first rib intersect in the sonoanatomical image.

      Group 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).

      Group 3: Local anesthetic mixture will be administered by multi injection method between the
      nerve groups seen in the sonoanatomical image.

      The diaphragm thickening fraction and evaluations will be made by another experienced
      anesthesiologist, double-blindness will be achieved by being blind to the patient's group.

      Effects of phrenic nerve block on diaphraghma muscle will be evaluated by diaphraghma
      thickining fraction.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.

      The diaphragm will be viewed as a structure with three distinct layers, including two
      parallel echoic lines (Diaphragmatic pleura and peritoneum) and a hypoechoic line between
      them (Diaphragm muscle) . The patient will be instructed to breathe up to total lung capacity
      (TLC) and then exhale to residual volume (RV).

      Several diaphragm images will be taken, at least three at the point of maximum thickening in
      TLC and at least three at minimum thickness in RV.

      On each B-mode image, diaphragm thickness will be measured from the middle of the pleural
      line to the middle of the peritoneal line. Then DTI will be 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.

      With this formula, we can determine the involvement of phrenic nerve by looking at the rate
      of diaphragm thickening before and after supraclavicular block in different groups.

      As a first line rescue anesthesia, patients will receive sedoanalgesia with remifentanil
      infusion. Laryngeal mask and general anesthesia will be commenced if needed. The
      postoperative analgesic regimen will routinely contain 1000 mg IV acetaminophen (3x1) and, if
      necessary, 1 mg opioid (Tramadol) per kg will be given.
    

Intervention name(s): Bupivacaine HCl 0.5% Injectable Solution; Prilocaine HCl % 2 injectable solution; adrenaline amp 0.5mg; Ultrasound Guided Supraclavicular Block Corner pocket approach; Ultrasound Guided Supraclavicular Block Corner pocket + intracluster approach; Ultrasound Guided Supraclavicular Block multi approach; diagraphma muscle evaluation with ultrasound
Intervention type(s): Drug; Drug; Drug; Procedure; Procedure; Procedure; Procedure
Intervention description(s): 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); 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); 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); 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.; 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).; 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.; 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.
Other intervention name(s): buvicaine %0.5,; priloc %2; adrenalin codex 0.5mg/1ml injectable solution
Intervention MeSH terms: Epinephrine; Racepinephrine; Bupivacaine; Prilocaine; Pharmaceutical Solutions; Epinephryl borate
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 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.
Group 1: Local anesthetic mixture will be given to the corner pocket - where the artery and the first rib intersect in the sonoanatomical image.
Group 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).
Group 3: Local anesthetic mixture will be administered by multi injection method between the nerve groups seen in the sonoanatomical image.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Brachial Plexus Block; Phrenic Nerve Paralysis; Respiratory Complication; Complications; nerve block; Diaphragm