Diaphragm InjuryNCT06329440
Comparison of Supraclavicular and Costoclavicular Brachial Plexus Blocks in Adult Patients
A study testing Ultrasonographic measurement of diaphragm thickness in people with Diaphragm Injury, run by Istanbul University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diaphragm Injury
- What is being tested?
- Ultrasonographic measurement of diaphragm thickness
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2024to 21 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients who will undergone upper extremity peripheral block
Who cannot join
- coagulation disorders
- paediatric patients
- Patients who do not accept regional anaesthesia
- known local anaesthetic allergy
- Patients who are under anticoagulant therapy
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University Istanbul Faculty of Medicine
Istanbul
About this study
Official title: 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.
- Conditions
- Diaphragm Injury
- Being tested
- Ultrasonographic measurement of diaphragm thickness
- Keywords
- regional anaesthesia, acute pain, peripheral block
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Ultrasonographic measurement of diaphragm thickness |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 4 hours
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start1 Apr 2024
- Primary completion20 Nov 2024
- Study completion21 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diaphragm InjuryStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meltem Savran Karadeniz, Istanbul University
- Investigators
- Meltem Savran Karadeniz, MD, Assoc Prof, Principal investigator, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06329440
- Sponsor's protocol ID
- 2023/880
- Status last verified
- Nov 2024
- First submitted
- 19 Mar 2024
- Last updated
- 25 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Diaphragma Thickness and Perfusion Index Change in Supraclavicular and Costoclavicular Brachial Plexus Block in Adult Patients Undergoing Hand Surgery
- ClinicalTrials.gov ID
- NCT06329440
- Acronym / sponsor ID
- 2023/880
- Conditions
- Diaphragm Injury
- Keywords
- regional anaesthesia, acute pain, peripheral block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 20 Nov 2024 (actual)
- Study completion
- 21 Nov 2024 (actual)
- First posted
- 26 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Costoclavicular block | Active comparator | Diagnostic Test: Ultrasonographic measurement of diaphragm thicknessPatients 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. |
| Supraclavicular block | Active comparator | Diagnostic Test: Ultrasonographic measurement of diaphragm thicknessPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adult patients who will undergone upper extremity peripheral block
Key exclusion criteria (6 listed)
- coagulation disorders
- paediatric patients
- Patients who do not accept regional anaesthesia
- known local anaesthetic allergy
- Patients who are under anticoagulant therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasonographic measurement of diaphragm thicknessLineer 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 | Diagnostic test | Costoclavicular block, Supraclavicular block |
Primary outcome
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.
5 secondary outcomes
Diaphragm thickness at the end of expirium (centimeters).
Time frame: Up to 4 hours
Diaphragm thickness at the end of inspirium (centimeters).
Time frame: Up to 4 hours.
Perfusion index change
Time frame: Up to 4 hours
Motor and sensory block onset time
Time frame: Up to 45 minute
Postoperative pain scores (0-10)
Time frame: Up to 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meltem Savran Karadeniz, MD, Assoc Prof principal investigator
Istanbul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasonographic measurement of diaphragm thickness in people with Diaphragm Injury, run by Istanbul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diaphragm thickness fraction (centimeters) (time frame: Up to 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2024.