Comparison of Different Approaches for Supraclavicular Block and Their Effects on Diaphragm Muscle Function

• ClinicalTrials.gov Identifier: NCT04756050
• Recruitment Status: Unknown
• First Posted: February 16, 2021
• Last Update Posted: February 16, 2021
• Sponsor: Bozyaka Training and Research Hospital
• Information provided by (Responsible Party): Çağrı Yeşilnacar, Bozyaka Training and Research Hospital

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Phrenic Nerve Paralysis; Diaphragm Sellae Meningioma; Complications; Respiratory Complication; Nerve Block; Brachial Plexus Block	Drug: Bupivacaine HCl 0.5% Injectable Solution; Drug: Prilocaine HCl % 2 injectable solution; Drug: adrenaline amp 0.5mg; Procedure: Ultrasound Guided Supraclavicular Block Corner pocket approach; Procedure: Ultrasound Guided Supraclavicular Block Corner pocket + intracluster approach; Procedure: Ultrasound Guided Supraclavicular Block multi approach; Procedure: diagraphma muscle evaluation with ultrasound	Phase 4

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 90 participants
• 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)

Masking Description

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.

Block evaluation and measurements will be made by a different experienced anesthesiologist .

• Primary Purpose: Treatment
• Official Title: Comparison of Different Approaches for Supraclavicular Block and Their Effects on Diaphragm Muscle Function Evaluated With Diaphragm Thickening Fraction
• Estimated Study Start Date: February 15, 2021
• Estimated Primary Completion Date: August 15, 2021
• Estimated Study Completion Date: March 2, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: corner pocket; The block will be performed by an experienced anesthesiologist in block applications under USG guidance. 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. 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) Local anesthetic mixture will be given to the corner pocket - where the artery and the first rib intersect in the sonoanatomical image.	Drug: 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); Other Name: buvicaine %0.5,; Drug: 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); Other Name: priloc %2; Drug: 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); Other Name: adrenalin codex 0.5mg/1ml injectable solution; Procedure: 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.; Procedure: 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.
Experimental: corner+intracluster; The block will be performed by an experienced anesthesiologist in block applications under USG guidance. 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 puncture20 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) 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).	Drug: 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); Other Name: buvicaine %0.5,; Drug: 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); Other Name: priloc %2; Drug: 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); Other Name: adrenalin codex 0.5mg/1ml injectable solution; Procedure: 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).; Procedure: 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.
Experimental: multi; The block will be performed by an experienced anesthesiologist in block applications under USG guidance. 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. 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) Local anesthetic mixture will be administered by multi injection method between the nerve groups seen in the sonoanatomical image.	Drug: 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); Other Name: buvicaine %0.5,; Drug: 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); Other Name: priloc %2; Drug: 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); Other Name: adrenalin codex 0.5mg/1ml injectable solution; Procedure: 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.; Procedure: 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.

Outcome Measures

Primary Outcome Measures :

1. Comparison of Three Different Approach for Supraclavicular Blocks Effects on Diaphragm Thickening Fraction [ Time Frame: Comparison of Diaphragm Thickening Fraction will be evaluated 30 minutes after the block is performed. ]
   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 formula: (Max thickness at the end of inspiration - Max thickness at the end of the expiration) / Max thickness at the end of the expiration. All patients will be evaluated with USG in a head-up position facing the side to be operated 30 minutes after the block is performed.

Secondary Outcome Measures :

1. The sensory block level [ Time Frame: Following the block operation, the sensory block level will be recorded at the 5th, 10th, 15th, 20th, 25th and 30th minutes ]
   Sensory block level; The level of block that will occur in the sensory areas of axillary, median, radial, ulnar, musculocutaneous, cutaneous brachia and cutaneous antebraki medialis nerves will be evaluated by performing a pinprick test and its level will be recorded (0 = Painful, no block; 1 = Partial block-analgesia, only feeling of touch; 2 = Complete block, no pain).
2. The motor block level [ Time Frame: Following the block operation, the motor block level will be recorded at the 5th, 10th, 15th, 20th, 25th and 30th minutes ]

   It will be evaluated with the Modified Bromage scale:

   0 = No blocks, he can lift his arm,

   1= Motor power is low but the arm is movable, 2 = The arm is immobile but the fingers are movable, 3 = Complete block, no movement in hand or arm

3. Block success [ Time Frame: At the 30th minute of LA application, ]
   It will be defined as the presence of the pinprick test in the musculacutaneous, radial, ulnar, median, cutaneous antebraki nerves with no pain or only feeling of touch. If any of these nerves are not blocked, it will be considered a failed block.
4. Postoperative analgesia time [ Time Frame: The hour when NRS> 1 in the first 24 hours will be recorded. ]
   Numeric rating scale; patient values pain between 0 and 10; 0 = No pain-10 = Intractable pain
5. Pain Score Follow-up [ Time Frame: 2nd, 6th, 12th and 24th hours ]
   Numeric rating scale; patient values pain between 0 and 10; 0 = No pain-10 = Intractable pain
6. Block return time [ Time Frame: The return time of sensory and motor block will be recorded within the first 24 hours. ]
   Sensory (the time from local anesthetic injection until the patient fully perceives the upper limb) and motor (the time from local anesthetic injection to the moment the patient's upper limb regains muscle strength) will be recorded as the time to return the block.
7. Block application time [ Time Frame: intraoperative (during block application) ]
   It will be defined as the time from the moment the needle passes through the skin until the local anesthetic is given and the needle is withdraw.
8. Block onset time [ Time Frame: baseline (before surgery) ]
   It will be defined as the time required to initiate anesthesia and analgesia in all 5 distal nerves from the local anesthetic injection.
9. Patient and surgeon satisfaction [ Time Frame: immediately after the surgery ]
   Patient and surgeon satisfaction will be evaluated as: 1 = Complete dissatisfaction, 2 = Moderate satisfaction, 3 = Full satisfaction after the procedure.
10. Undesirable side effects: [ Time Frame: Patients will be observed for 24 hours, ]
    Recorded when there is vascular puncture, hematoma, signs of LA toxicity, respiratory distress, pneumothorax, and Horner Syndrome.
11. The first opioid requirement hour [ Time Frame: If pain occurs within the first 24 hours from the time the block transaction ends. ]
    The first hour of opioid requirement of the patients will be recorded.(When NRS> 3) Opioids(Tramadol) will be administered to patients in case demanded.
12. 24-hour total opioid consumption [ Time Frame: It will be defined as 24 hours from the time the block transaction ends. ]
    It will be recorded how much opioid he needs to use for 24 hours.Opioids(Tramadol) will be administered to patients in case demanded.
13. Chronic pain questionnaire [ Time Frame: 6 months after operation ]
    After 6 months, patients will be called and questioned by phone.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Çağrı Yeşilnacar, MD; +905386052854; cyesilnacar@gmail.com

Contact: Zeki T Tekgül, Assoc Prof; +905058554705; zekitekgul@yahoo.com

Locations

Turkey

Izmir Bozyaka Training and Research Hospital

İzmir, Karabaglar, Turkey, 35170

Sponsors and Collaborators

Bozyaka Training and Research Hospital

Investigators

• Study Chair: Çağrı Yeşilnacar, MD; Izmir Bozyaka Training and Research Hospital
• Study Chair: Zeki T Tekgül, Assoc Prof; Izmir Bozyaka Training and Research Hospital
• Study Chair: AYSUN A KAR, MD; Izmir Bozyaka Training and Research Hospital
• Study Chair: TAŞKIN ALTAY, Assoc Prof; Izmir Bozyaka Training and Research Hospital

More Information

Publications:

Ferrari G, De Filippi G, Elia F, Panero F, Volpicelli G, Apra F. Diaphragm ultrasound as a new index of discontinuation from mechanical ventilation. Crit Ultrasound J. 2014 Jun 7;6(1):8. doi: 10.1186/2036-7902-6-8. eCollection 2014.

Petrar SD, Seltenrich ME, Head SJ, Schwarz SK. Hemidiaphragmatic paralysis following ultrasound-guided supraclavicular versus infraclavicular brachial plexus blockade: a randomized clinical trial. Reg Anesth Pain Med. 2015 Mar-Apr;40(2):133-8. doi: 10.1097/AAP.0000000000000215.

Renes SH, Spoormans HH, Gielen MJ, Rettig HC, van Geffen GJ. Hemidiaphragmatic paresis can be avoided in ultrasound-guided supraclavicular brachial plexus block. Reg Anesth Pain Med. 2009 Nov-Dec;34(6):595-9. doi: 10.1097/aap.0b013e3181bfbd83.

• Responsible Party: Çağrı Yeşilnacar, anesthesiology resident, Bozyaka Training and Research Hospital
• ClinicalTrials.gov Identifier: NCT04756050
• Other Study ID Numbers: cagritez
• First Posted: February 16, 2021
• Last Update Posted: February 16, 2021
• Last Verified: February 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Çağrı Yeşilnacar, Bozyaka Training and Research Hospital:

Brachial Plexus Block; Phrenic Nerve Paralysis; Respiratory Complication; Complications; nerve block; Diaphragm

Additional relevant MeSH terms:

Meningioma; Paralysis; Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Vascular Tissue; Meningeal Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Nervous System Diseases; Neurologic Manifestations; Epinephrine; Racepinephrine; Bupivacaine; Prilocaine; Pharmaceutical Solutions; Epinephryl borate; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Adrenergic beta-Agonists