NCT06329440

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 19, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 26, 2024

Completed
6 days until next milestone

Study Start

First participant enrolled

April 1, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2024

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 21, 2024

Completed
Last Updated

November 25, 2024

Status Verified

November 1, 2024

Enrollment Period

8 months

First QC Date

March 19, 2024

Last Update Submit

November 21, 2024

Conditions

Diaphragm Injury

Keywords

regional anaesthesiaacute painperipheral block

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

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

    Up to 4 hours

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

    Up to 4 hours.

  • Perfusion index change

    Up to 4 hours

  • Motor and sensory block onset time

    Up to 45 minute

  • Postoperative pain scores (0-10)

    Up to 24 hours

Study Arms (2)

Costoclavicular block

ACTIVE COMPARATOR

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

Supraclavicular block

ACTIVE COMPARATOR

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

Interventions

Ultrasonographic measurement of diaphragm thicknessDIAGNOSTIC_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

Costoclavicular blockSupraclavicular block

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult patients who will undergone upper extremity peripheral block

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University Istanbul Faculty of Medicine

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Acute Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Meltem Savran Karadeniz, MD, Assoc Prof

    Istanbul University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Assoc Prof

Study Record Dates

First Submitted

March 19, 2024

First Posted

March 26, 2024

Study Start

April 1, 2024

Primary Completion

November 20, 2024

Study Completion

November 21, 2024

Last Updated

November 25, 2024

Record last verified: 2024-11

Locations

TU(1)