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

NCT04756050 | Completed Phase 4 DMC

• 1 other identifier: cagritez
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Phrenic Nerve Paralysis; Diaphragm Sellae Meningioma; Complications; Respiratory Complication; Nerve Block; Brachial Plexus Block

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Comparison of Three Different Approach for Supraclavicular Blocks Effects on Diaphragm Thickening Fraction

  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.

  Comparison of Diaphragm Thickening Fraction will be evaluated 30 minutes after the block is performed.

Secondary Outcomes (13)

• The sensory block level

  Following the block operation, the sensory block level will be recorded at the 5th, 10th, 15th, 20th, 25th and 30th minutes

• The motor block level

  Following the block operation, the motor block level will be recorded at the 5th, 10th, 15th, 20th, 25th and 30th minutes

• Block success

  At the 30th minute of LA application,

• Postoperative analgesia time

  The hour when NRS> 1 in the first 24 hours will be recorded.

• Pain Score Follow-up

  2nd, 6th, 12th and 24th hours

Study Arms (3)

corner pocket

EXPERIMENTAL

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; Drug: Prilocaine HCl % 2 injectable solution; Drug: adrenaline amp 0.5mg; Procedure: Ultrasound Guided Supraclavicular Block Corner pocket approach; Procedure: diagraphma muscle evaluation with ultrasound

corner+intracluster

EXPERIMENTAL

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; Drug: Prilocaine HCl % 2 injectable solution; Drug: adrenaline amp 0.5mg; Procedure: Ultrasound Guided Supraclavicular Block Corner pocket + intracluster approach; Procedure: diagraphma muscle evaluation with ultrasound

multi

EXPERIMENTAL

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; Drug: Prilocaine HCl % 2 injectable solution; Drug: adrenaline amp 0.5mg; Procedure: Ultrasound Guided Supraclavicular Block multi approach; Procedure: diagraphma muscle evaluation with ultrasound

Interventions

Bupivacaine HCl 0.5% Injectable Solution DRUG

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)

Also known as: buvicaine %0.5,

corner pocket; corner+intracluster; multi

Prilocaine HCl % 2 injectable solution DRUG

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)

Also known as: priloc %2

corner pocket; corner+intracluster; multi

adrenaline amp 0.5mg DRUG

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)

Also known as: adrenalin codex 0.5mg/1ml injectable solution

corner pocket; corner+intracluster; multi

Ultrasound Guided Supraclavicular Block Corner pocket approach PROCEDURE

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.

corner pocket

Ultrasound Guided Supraclavicular Block Corner pocket + intracluster approach PROCEDURE

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).

corner+intracluster

Ultrasound Guided Supraclavicular Block multi approach PROCEDURE

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.

multi

diagraphma muscle evaluation with ultrasound PROCEDURE

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.

corner pocket; corner+intracluster; multi

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bozyaka Training and Research Hospital: lead

Study Sites (1)

Izmir Bozyaka Training and Research Hospital

Izmir, Karabaglar, 35170, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 24949192 BACKGROUND

• 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.

  PMID: 25650633 BACKGROUND

• 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.

  PMID: 19916254 BACKGROUND

MeSH Terms

Interventions

Bupivacaine; High-Energy Shock Waves

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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 .
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: anesthesiology resident

Model Details: 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.

Study Record Dates

• First Submitted: February 8, 2021
• First Posted: February 16, 2021
• Study Start: February 16, 2021
• Primary Completion: August 15, 2021
• Study Completion: March 2, 2022
• Last Updated: June 13, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)