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

NCT04756050 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2023-06-13

No results posted yet for this study

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

Interventions

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)

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)

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)

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

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

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.

Sponsors & Collaborators

  • Bozyaka Training and Research Hospital

    lead OTHER

Principal Investigators

  • Çağrı Yeşilnacar, MD · Izmir Bozyaka Training and Research Hospital

  • Zeki T Tekgül, Assoc Prof · Izmir Bozyaka Training and Research Hospital

  • AYSUN A KAR, MD · Izmir Bozyaka Training and Research Hospital

  • TAŞKIN ALTAY, Assoc Prof · Izmir Bozyaka Training and Research Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-16
Primary Completion
2021-08-15
Completion
2022-03-02

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04756050 on ClinicalTrials.gov