Hemidiaphragmatic ParalysisCCLS-ICBNCT07386470
Comparison of Costoclavicular and Lateral Sagittal Infraclavicular Blocks
A study testing Ultrasound-guided Infraclavicular block in people with Hemidiaphragmatic Paralysis and Upper Extremity Surgery, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
This randomized clinical study aims to compare the effects of two different ultrasound-guided infraclavicular brachial plexus block techniques-costoclavicular and lateral sagittal approaches-in patients undergoing forearm, wrist, or hand surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hemidiaphragmatic Paralysis, Upper Extremity Surgery
- What is being tested?
- Ultrasound-guided Infraclavicular block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2022to 15 Apr 2023
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18-80 years
- ASA physical status I-III
- Scheduled for forearm, wrist, or hand surgery
- Planned infraclavicular brachial plexus block
Who cannot join
- Refusal of regional anesthesia
- Known allergy to local anesthetics
- Infection at the block site
- Pre-existing neurological deficit in the operative limb
- Severe pulmonary disease
- Coagulopathy or sepsis
- BMI > 40 kg/m²
- Psychiatric disorders
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gazi University Faculty of Medicine, Department of Anesthesiology and Reanimation
Ankara, Ankara, 06560
About this study
Official title: Effect of Costoclavicular Versus Lateral Sagittal Infraclavicular Block on Hemidiaphragmatic Function: A Randomized Clinical Study
This randomized clinical study aims to compare the effects of two different ultrasound-guided infraclavicular brachial plexus block techniques-costoclavicular and lateral sagittal approaches-in patients undergoing forearm, wrist, or hand surgery.
The primary objective of the study is to evaluate and compare the incidence of hemidiaphragmatic dysfunction associated with these two block techniques. Secondary outcomes include sensory and motor block characteristics, postoperative pain scores, analgesic requirements, and potential block-related complications.
Read more
Eligible adult patients scheduled for elective forearm or hand surgery are randomly assigned to receive either a costoclavicular or a lateral sagittal infraclavicular nerve block using bupivacaine under ultrasound guidance. Standard general anesthesia and postoperative analgesia protocols are applied.
The results of this study are expected to provide evidence on the relative safety and efficacy of these two infraclavicular block approaches, particularly regarding diaphragmatic function, and to help guide anesthesiologists in selecting the most appropriate regional anesthesia technique for upper extremity surgery.
- Being tested
- Ultrasound-guided Infraclavicular block
- Keywords
- Infraclavicular brachial plexus block, hemidiaphragmatic paralysis, costoclavicular brachial plexus block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided Infraclavicular blockProcedure or surgery
Also called costoclavicular infraclavicular block, lateral sagital infraclavicular block
Ultrasound-guided infraclavicular brachial plexus block performed using either the costoclavicular or lateral sagittal approach with standardized local anesthetic volume.
| Study group | Role | What they receive |
|---|---|---|
| Costoclavicular infraclavicular block | Experimental | Ultrasound-guided costoclavicular infraclavicular brachial plexus block Receives: Procedure: Ultrasound-guided Infraclavicular block |
| Lateral sagittal infraclavicular block | Active comparator | Ultrasound-guided lateral sagittal infraclavicular brachial plexus block Receives: Procedure: Ultrasound-guided Infraclavicular block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diaphragmatic excursion
Diaphragmatic excursion measured by ultrasound during normal and deep breathing to asses the effect of costoclavicular and lateral sagittal infraclavicular block techniques.
Measured: Baseline(pre-block) and 30 minutes after block performance.
Secondary outcomes (2)
Sensory and motor block onset time
Time from completion of the infraclavicular block to achievement of complete sensory and motor block in the radial, median, ulnar, and musculocutaneous nerve distributions. Sensory and motor function were assessed every 5 minutes for up to 30 minutes after block performance, and block onset time was defined as the time to complete block.
Measured: Within the first 30 minutes after block performance.
Time to first postoperative analgesic requirement
Time from the end of the surgery to the first analgesic requirement.
Measured: Within the first 24 hours postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start15 Oct 2022
- Primary completion15 Apr 2023
- Study completion15 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemidiaphragmatic ParalysisStudies of the same condition, open and under way.
- More trials run by Gazi 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This was a prospective, randomized, parallel group study comparing two ultrasound guided infraclavicular block techniques
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İrfan GUNGOR, Gazi University
- Investigators
- Irfan Güngör, MD, Principal investigator, Gazi University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07386470
- Sponsor's protocol ID
- ICB-CC-LS-2022
- Acronym
- CCLS-ICB
- Status last verified
- Jan 2026
- First submitted
- 28 Jan 2026
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Costoclavicular Versus Lateral Sagittal Infraclavicular Block on Hemidiaphragmatic Function: A Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT07386470
- Acronym / sponsor ID
- CCLS-ICB / ICB-CC-LS-2022
- Keywords
- Infraclavicular brachial plexus block, hemidiaphragmatic paralysis, costoclavicular brachial plexus block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 15 Oct 2022 (actual)
- Primary completion
- 15 Apr 2023 (actual)
- Study completion
- 15 Apr 2023 (actual)
- First posted
- 4 Feb 2026 (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.
This randomized clinical study aims to compare the effects of two different ultrasound-guided infraclavicular brachial plexus block techniques-costoclavicular and lateral sagittal approaches-in patients undergoing forearm, wrist, or hand surgery.
The primary objective of the study is to evaluate and compare the incidence of hemidiaphragmatic dysfunction associated with these two block techniques. Secondary outcomes include sensory and motor block characteristics, postoperative pain scores, analgesic requirements, and potential block-related complications.
Eligible adult patients scheduled for elective forearm or hand surgery are randomly assigned to receive either a costoclavicular or a lateral sagittal infraclavicular nerve block using bupivacaine under ultrasound guidance. Standard general anesthesia and postoperative analgesia protocols are applied.
The results of this study are expected to provide evidence on the relative safety and efficacy of these two infraclavicular block approaches, particularly regarding diaphragmatic function, and to help guide anesthesiologists in selecting the most appropriate regional anesthesia technique for upper extremity surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This was a prospective, randomized, parallel group study comparing two ultrasound guided infraclavicular block techniques
| Arm | Type | Receives |
|---|---|---|
| Costoclavicular infraclavicular block | Experimental | Procedure: Ultrasound-guided Infraclavicular blockUltrasound-guided costoclavicular infraclavicular brachial plexus block |
| Lateral sagittal infraclavicular block | Active comparator | Procedure: Ultrasound-guided Infraclavicular blockUltrasound-guided lateral sagittal infraclavicular brachial plexus block |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 18-80 years
- ASA physical status I-III
- Scheduled for forearm, wrist, or hand surgery
- Planned infraclavicular brachial plexus block
Key exclusion criteria (8 listed)
- Refusal of regional anesthesia
- Known allergy to local anesthetics
- Infection at the block site
- Pre-existing neurological deficit in the operative limb
- Severe pulmonary disease
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 |
|---|---|---|
| Ultrasound-guided Infraclavicular blockAlso: costoclavicular infraclavicular block, lateral sagital infraclavicular blockUltrasound-guided infraclavicular brachial plexus block performed using either the costoclavicular or lateral sagittal approach with standardized local anesthetic volume. | Procedure or surgery | Costoclavicular infraclavicular block, Lateral sagittal infraclavicular block |
Primary outcome
Diaphragmatic excursion
Time frame: Baseline(pre-block) and 30 minutes after block performance.
Diaphragmatic excursion measured by ultrasound during normal and deep breathing to asses the effect of costoclavicular and lateral sagittal infraclavicular block techniques.
2 secondary outcomes
Sensory and motor block onset time
Time frame: Within the first 30 minutes after block performance.
Time to first postoperative analgesic requirement
Time frame: Within the first 24 hours postoperatively.
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 5 Feb 2026.
- Individual participant dataSharing planned: No
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Evaluating Hemidiaphragmatic Paralysis With Prolonged Neural Blockade From an Interscalene Brachial Plexus Block
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Evaluation of Diaphragmatic Function After Interscalene Block With Liposomal Bupivacaine
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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.
Irfan Güngör, MD principal investigator
Gazi University Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-guided Infraclavicular block in people with Hemidiaphragmatic Paralysis and Upper Extremity Surgery, run by Gazi 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 4 inclusion and 8 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 5 Feb 2026. 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?
Diaphragmatic excursion (time frame: Baseline(pre-block) and 30 minutes after block performance.). 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 5 Feb 2026.