Comparison of Supraclavicular and Costoclavicular Brachial Plexus Blocks in Adult Patients

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

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.

Study Overview

• Status: Recruiting
• Conditions: Diaphragm Injury
• Intervention / Treatment: Diagnostic test: Ultrasonographic measurement of diaphragm thickness

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Meltem Savran Karadeniz, MD, Assoc. Prof.; Phone Number: 31742 00904142000; Email: mskaradeniz@gmail.com
• Study Contact Backup: Name: Ozgur Selek, MD; Phone Number: 00905057883600; Email: ozgrselek@gmail.com

Study Locations

• Turkey
  • Istanbul, Turkey
    • Recruiting
    • Istanbul University Istanbul Faculty of Medicine
    • Contact: Meltem Savran Karadeniz, MD, Assoc Prof; Email: mskaradeniz@gmail.com
    • Contact: Ozgur Selek, MD; Phone Number: 00905057883600

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Costoclavicular block; Patients who will receive costoclavicular brachial plexus block for hand surgery. Costoclavicular block is performed via depositing local anesthetic in the costoclavicular space which is placed in the posterior of middle part of the clavicle. The diaphragma thickness will be evaluated after the surgery in postanesthesia care unit.	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
Active Comparator: Supraclavicular block; Patients who will receive supraclavicular brachial plexus block for hand surgery. Supraclavicular is performed via depositing local anesthetic using corner pocket technique which is described as injecting the drugs to the inferolateral side of axillary artery above the 1st rib. The diaphragma thickness will be evaluated after the surgery in postanesthesia care unit.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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.
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
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
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

Collaborators and Investigators

• Sponsor: Istanbul University
• Investigators: Principal Investigator: Meltem Savran Karadeniz, MD, Assoc Prof, Istanbul University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): October 5, 2024

Study Registration Dates

• First Submitted: March 19, 2024
• First Submitted That Met QC Criteria: March 19, 2024
• First Posted (Actual): March 26, 2024

Study Record Updates

• Last Update Posted (Actual): April 18, 2024
• Last Update Submitted That Met QC Criteria: April 17, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: acute pain; regional anaesthesia; peripheral block
• Other Study ID Numbers: 2023/880

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No