Comparison of Supraclavicular and Costoclavicular Brachial Plexus Blocks in Adult Patients

Diaphragm Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06329440
• Other study ID #: 2023/880
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: October 5, 2024

Study information

• Verified date: April 2024
• Source: Istanbul University
• Contact: Meltem Savran Karadeniz, MD, Assoc. Prof.
• Phone: 00904142000
• Email: mskaradeniz[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: October 5, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diaphragm Injury

Intervention

Diagnostic Test:
• Ultrasonographic measurement of diaphragm thickness
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

Locations

Country	Name	City	State
Turkey	Istanbul University Istanbul Faculty of Medicine	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diaphragm thickness fraction (centimeters)	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.	Up to 4 hours
Secondary	Diaphragm thickness at the end of expirium (centimeters).	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.	Up to 4 hours
Secondary	Diaphragm thickness at the end of inspirium (centimeters).	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.	Up to 4 hours.
Secondary	Perfusion index change	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.	Up to 4 hours
Secondary	Motor and sensory block onset time	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.	Up to 45 minute
Secondary	Postoperative pain scores (0-10)	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.	Up to 24 hours