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Completed

NCT Number: NCT06329440

Comparison of Supraclavicular and Costoclavicular Brachial Plexus Blocks in Adult Patients

Hemidiaphragmatic paresis is a common side effect of brachial plexus blocks such as supraclavicular or infraclavicular block techniques. It has been shown that diaphragma thickness is affected at some extent in supraclavicular block and also in costoclavicular block which is accepted as an infraclavicular approach. However, these two approaches have not been extensively investigated before in terms of the diaphragmatic paresis. Here, it is aimed to compare these two methods considering their effects on diaphragma thickness in inspirium and in expirium. Moreover, the performance properties such as motor and sensory block onset, needle visualization time, needle visualization difficulty, postoperative pain scores, and lastly the perfusion index which is known to be reflecting vasodilation will be investigated.

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Key information

Conditions

Diaphragm Injury Acute Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul University Istanbul Faculty of Medicine

Istanbul, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • adult patients who will undergone upper extremity peripheral block

Exclusion criteria

  • coagulation disorders
  • paediatric patients
  • Patients who do not accept regional anaesthesia
  • known local anaesthetic allergy
  • Patients who are under anticoagulant therapy
  • Pregnancy

Treatment and study plan

Ultrasonographic measurement of diaphragm thickness

Diagnostic Test

Lineer probe of the ultrasound machine will be placed sagitally on the level of 9th to 11th rib in order to observe diaphragmatic thickness change during a sniff. The thicknesses will be measured both in full expiration (Te) and full inspirium (Ti) in centimeters. The diaphragm thickness fraction will be calculated as follows: (Ti-Te)/Te

Primary outcomes

  1. Diaphragm thickness fraction (centimeters)

    Time frame: Up to 4 hours

    The formula is as follows: (Diaphragm thickness at the end of inspirium - Diaphragm thickness at the end of expirium)/ Diaphragm thickness at the end of expirium.

    This ratio gives the fraction of diaphragm thickness which reflects possible diaphragm paresis or paralysis. The thickness is measured during a sniff test via ultrasound for which the probe is placed sagitally on the level of 9th to 11th rib on the mid axillary line.

Secondary outcomes

  1. Diaphragm thickness at the end of expirium (centimeters).

    Time frame: Up to 4 hours

    The thickness is measured during a sniff test via ultrasound for which the probe is placed sagitally on the level of 9th to 11th rib on the mid axillary line.

  2. Diaphragm thickness at the end of inspirium (centimeters).

    Time frame: Up to 4 hours.

    The thickness is measured during a sniff test via ultrasound for which the probe is placed sagitally on the level of 9th to 11th rib on the mid axillary line.

  3. Perfusion index change

    Time frame: Up to 4 hours

    Perfusion index is measured before and after peripheral block (10th, 20th, and 30th minute after block performance), and also at the end of the case. It is calculated as pulsatile signal (AC)X100/non-pulsatile signal (DC). This indicator shows the block related regional vasodilation. Both block techniques will be compared in this regard.

  4. Motor and sensory block onset time

    Time frame: Up to 45 minute

    After performing the block, n.musculocutaneus, n.medianus, n.radialis, and n.ulnaris will be evaluated via physical examination every 5 minute.For the sensory evaluation, a blunt needle will be pinned on the relevant areas (median nerve: volar face of the middle finger, ulnar nerve: volar face of the 5th finger, radial nerve: hand dorsum and musculocutaneus nerve: lateral part of forearm), and scored as follows: 0: feels pain/absent sensorial blockade, 1: feels touch/partial blockade, 2: no sense/complete blockade. Motor activity will be evaluated via checking the motor response of the same branches and accordingly scoring was as follows: 0: no motor block, 1: partial motor block, 2: total motor block.

  5. Postoperative pain scores (0-10)

    Time frame: Up to 24 hours

    Pain will be evaluated using numeric rating scale which is between 0 to 10 (0= no pain, 10=the worst pain experienced). This scale will be questioned in postoperative 1st, 2nd, 4th, 6th, 12th and 24th hours.

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Official study title

Comparison of Diaphragma Thickness and Perfusion Index Change in Supraclavicular and Costoclavicular Brachial Plexus Block in Adult Patients Undergoing Hand Surgery

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 26, 2024
Registry last updated
Nov 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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