Diaphragmatic ExcursionICB-SNBNCT07640464
Diaphragmatic Effects of Combined Infraclavicular Brachial Plexus Block and Suprascapular Nerve Block
An observational study of Diaphragmatic Excursion and Hemidiaphragmatic Paralysis, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
This prospective observational study was conducted to evaluate the effects of a combined infraclavicular brachial plexus block and anterior suprascapular nerve block on diaphragmatic function in patients undergoing arthroscopic shoulder surgery. A total of 61 adult patients were enrolled in the study. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diaphragmatic Excursion, Hemidiaphragmatic Paralysis, Arthroscopic Shoulder Surgery
- How many people
- 61 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Feb 2025to 20 Jul 2025
- Phase
- Observational
- 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
Study population: Adult patients aged 18-80 years with ASA physical status I-III undergoing elective arthroscopic shoulder surgery at Gazi University Faculty of Medicine Hospital. Eligible participants received ultrasound-guided combined infraclavicular brachial plexus block and anterior suprascapular nerve block. The study evaluated changes in diaphragmatic excursion measured by ultrasonography before and after block administration.
Who may be able to join
- Patients aged 18-80 years.
- ASA physical status I-III.
- Scheduled for elective arthroscopic shoulder surgery.
- Ability to provide written informed consent
Who cannot join
- Refusal to undergo peripheral nerve block.
- Pre-existing peripheral neuropathy.
- Known pulmonary, hepatic, or renal disease.
- Allergy to local anesthetics.
- Infection at the block site.
- Pre-existing neurological deficit.
Show all 12Show fewer
- Body mass index (BMI) > 40 kg/m².
- Coagulopathy.
- Sepsis.
- Previous surgery at the planned block site.
- Major psychiatric disorders.
- Inability to complete diaphragmatic ultrasonographic assessment.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gazi University Faculty of Medicine Hospital
Ankara, Ankara, 06500
About this study
Official title: Evaluation of the Effects of Combined Infraclavicular Brachial Plexus Block and Suprascapular Nerve Block on the Diaphragm in Arthroscopic Shoulder Surgery
This prospective observational study was conducted to evaluate the effects of a combined infraclavicular brachial plexus block and anterior suprascapular nerve block on diaphragmatic function in patients undergoing arthroscopic shoulder surgery. A total of 61 adult patients were enrolled in the study. Diaphragmatic excursion was assessed using ultrasonography both prior to block administration and 30 minutes following the procedure during normal and deep breathing. The primary objective was to assess changes in diaphragmatic excursion and determine the incidence of hemidiaphragmatic paralysis associated with this combined block technique. Secondary outcomes included block performance time, duration of postoperative analgesia, the need for additional intraoperative sedation or analgesia, the occurrence of adverse events, and levels of patient and surgeon satisfaction. The study sought to determine whether this regional anesthesia approach could provide effective anesthesia and analgesia while minimizing impairment of diaphragmatic function.
Read the detailed description
This prospective observational study was conducted to evaluate the effects of combined infraclavicular brachial plexus block and anterior suprascapular nerve block on diaphragmatic excursion in patients undergoing elective arthroscopic shoulder surgery.
Patients scheduled for arthroscopic shoulder surgery under regional anesthesia were enrolled in the study. Prior to block administration, baseline diaphragmatic excursion was assessed using ultrasonography during both normal and deep breathing. Each measurement was repeated three times, and the mean value was recorded. The same measurements were repeated 30 minutes after completion of the block procedures using an identical protocol.
The percentage change in diaphragmatic excursion between baseline and post-block measurements was calculated for both normal and deep breathing. Hemidiaphragmatic paralysis was categorized according to the degree of reduction in diaphragmatic excursion as absent (≤25% reduction), partial (25.1-74.9% reduction), or complete (≥75% reduction).
All nerve blocks were performed under ultrasound guidance by anesthesiologists experienced in regional anesthesia techniques. The infraclavicular brachial plexus block was performed using 15 mL of 0.5% bupivacaine deposited around the posterior cord and 8 mL of 0.5% bupivacaine around the lateral cord. The anterior suprascapular nerve block was performed with 7 mL of 0.5% bupivacaine. In addition, arthroscopic portal sites were infiltrated with 10 mL of 0.2% bupivacaine to provide supplementary analgesia.
All patients received intravenous midazolam (2 mg) and paracetamol (1 g) during the intraoperative period. Additional analgesic or sedative medication was administered when required according to clinical conditions and surgical needs. Block performance time, requirement for supplemental analgesia or sedation, and any block-related adverse events were recorded.
The primary outcome measure was the change in diaphragmatic excursion measured by ultrasonography 30 minutes after block administration. Secondary outcome measures included the incidence and severity of hemidiaphragmatic paralysis, block performance time, duration of postoperative analgesia, need for additional intraoperative analgesia or sedation, time to first analgesic requirement, patient and surgeon satisfaction, block-related complications, and conversion to general anesthesia.
The study was designed to investigate whether the combination of infraclavicular brachial plexus block and anterior suprascapular nerve block could provide effective anesthesia and analgesia for arthroscopic shoulder surgery while minimizing impairment of diaphragmatic function and reducing the incidence of clinically significant hemidiaphragmatic paralysis.
- Keywords
- Anterior Suprascapular Nerve Block, Infraclavicular Brachial Plexus Block, Diaphragmatic Excursion, Shoulder Arthroscopy, Regional Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients Undergoing Arthroscopic Shoulder Surgery | Patients undergoing arthroscopic shoulder surgery who received a combined infraclavicular brachial plexus block and anterior suprascapular nerve block. Diaphragmatic excursion was evaluated using ultrasonography before and after block administration. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Diaphragmatic Excursion at 30 Minutes After Block Administration
Diaphragmatic excursion measured by ultrasonography during normal and deep breathing before block administration and 30 minutes after block administration. The percentage change from baseline was calculated.
Measured: 30 minutes after block administration
Secondary outcomes (6)
Incidence of Hemidiaphragmatic Paralysis
Presence of hemidiaphragmatic paralysis determined by ultrasonographic assessment of diaphragmatic excursion.
Measured: 30 minutes after block administration
Degree of Hemidiaphragmatic Paralysis
Hemidiaphragmatic paralysis classified as absent (≤25% reduction), partial (25.1-74.9% reduction), or complete (≥75% reduction)
Measured: 30 minutes after block administration
Block Performance Time
Time required to complete the combined infraclavicular brachial plexus block and anterior suprascapular nerve block.
Measured: From needle insertion to completion of the block procedure
Additional Intraoperative Analgesia Requirement
Requirement for supplemental analgesic medication during surgery.
Measured: From surgical incision to the end of surgery
Time to First Analgesic Requirement
Time from completion of the block procedure to the first postoperative analgesic request.
Measured: Up to 24 hours after surgery
Block-Related Complications
Incidence of block-related adverse events including Horner syndrome, hoarseness, nausea/vomiting, and hemodynamic complications.
Measured: From block administration until 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study start22 Feb 2025
- Primary completion20 Jul 2025
- Study completion20 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diaphragmatic ExcursionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ceren Gul AKPINAR, Gazi University
- Investigators
- IRFAN GUNGOR, MD, Principal investigator, Gazi university faculty of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07640464
- Sponsor's protocol ID
- 2024-GUTF-028
- Acronym
- ICB-SNB
- Status last verified
- Jun 2026
- First submitted
- 31 May 2026
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data collected during the study will not be shared with other researchers because of institutional policies, ethical considerations, and protection of participant confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Combined Infraclavicular Brachial Plexus Block and Suprascapular Nerve Block on the Diaphragm in Arthroscopic Shoulder Surgery
- ClinicalTrials.gov ID
- NCT07640464
- Acronym / sponsor ID
- ICB-SNB / 2024-GUTF-028
- Keywords
- Anterior Suprascapular Nerve Block, Infraclavicular Brachial Plexus Block, Diaphragmatic Excursion, Shoulder Arthroscopy, Regional Anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 22 Feb 2025 (actual)
- Primary completion
- 20 Jul 2025 (actual)
- Study completion
- 20 Jul 2025 (actual)
- First posted
- 10 Jun 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 prospective observational study was conducted to evaluate the effects of a combined infraclavicular brachial plexus block and anterior suprascapular nerve block on diaphragmatic function in patients undergoing arthroscopic shoulder surgery. A total of 61 adult patients were enrolled in the study. Diaphragmatic excursion was assessed using ultrasonography both prior to block administration and 30 minutes following the procedure during normal and deep breathing. The primary objective was to assess changes in diaphragmatic excursion and determine the incidence of hemidiaphragmatic paralysis associated with this combined block technique. Secondary outcomes included block performance time, duration of postoperative analgesia, the need for additional intraoperative sedation or analgesia, the occurrence of adverse events, and levels of patient and surgeon satisfaction. The study sought to determine whether this regional anesthesia approach could provide effective anesthesia and analgesia while minimizing impairment of diaphragmatic function.
Detailed description
This prospective observational study was conducted to evaluate the effects of combined infraclavicular brachial plexus block and anterior suprascapular nerve block on diaphragmatic excursion in patients undergoing elective arthroscopic shoulder surgery.
Patients scheduled for arthroscopic shoulder surgery under regional anesthesia were enrolled in the study. Prior to block administration, baseline diaphragmatic excursion was assessed using ultrasonography during both normal and deep breathing. Each measurement was repeated three times, and the mean value was recorded. The same measurements were repeated 30 minutes after completion of the block procedures using an identical protocol.
The percentage change in diaphragmatic excursion between baseline and post-block measurements was calculated for both normal and deep breathing. Hemidiaphragmatic paralysis was categorized according to the degree of reduction in diaphragmatic excursion as absent (≤25% reduction), partial (25.1-74.9% reduction), or complete (≥75% reduction).
All nerve blocks were performed under ultrasound guidance by anesthesiologists experienced in regional anesthesia techniques. The infraclavicular brachial plexus block was performed using 15 mL of 0.5% bupivacaine deposited around the posterior cord and 8 mL of 0.5% bupivacaine around the lateral cord. The anterior suprascapular nerve block was performed with 7 mL of 0.5% bupivacaine. In addition, arthroscopic portal sites were infiltrated with 10 mL of 0.2% bupivacaine to provide supplementary analgesia.
All patients received intravenous midazolam (2 mg) and paracetamol (1 g) during the intraoperative period. Additional analgesic or sedative medication was administered when required according to clinical conditions and surgical needs. Block performance time, requirement for supplemental analgesia or sedation, and any block-related adverse events were recorded.
The primary outcome measure was the change in diaphragmatic excursion measured by ultrasonography 30 minutes after block administration. Secondary outcome measures included the incidence and severity of hemidiaphragmatic paralysis, block performance time, duration of postoperative analgesia, need for additional intraoperative analgesia or sedation, time to first analgesic requirement, patient and surgeon satisfaction, block-related complications, and conversion to general anesthesia.
The study was designed to investigate whether the combination of infraclavicular brachial plexus block and anterior suprascapular nerve block could provide effective anesthesia and analgesia for arthroscopic shoulder surgery while minimizing impairment of diaphragmatic function and reducing the incidence of clinically significant hemidiaphragmatic paralysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients Undergoing Arthroscopic Shoulder Surgery | – | –Patients undergoing arthroscopic shoulder surgery who received a combined infraclavicular brachial plexus block and anterior suprascapular nerve block. Diaphragmatic excursion was evaluated using ultrasonography before and after block administration. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients aged 18-80 years with ASA physical status I-III undergoing elective arthroscopic shoulder surgery at Gazi University Faculty of Medicine Hospital. Eligible participants received ultrasound-guided combined infraclavicular brachial plexus block and anterior suprascapular nerve block. The study evaluated changes in diaphragmatic excursion measured by ultrasonography before and after block administration.
Key inclusion criteria (4 listed)
- Patients aged 18-80 years.
- ASA physical status I-III.
- Scheduled for elective arthroscopic shoulder surgery.
- Ability to provide written informed consent
Key exclusion criteria (12 listed)
- Refusal to undergo peripheral nerve block.
- Pre-existing peripheral neuropathy.
- Known pulmonary, hepatic, or renal disease.
- Allergy to local anesthetics.
- Infection at the block site.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Diaphragmatic Excursion at 30 Minutes After Block Administration
Time frame: 30 minutes after block administration
Diaphragmatic excursion measured by ultrasonography during normal and deep breathing before block administration and 30 minutes after block administration. The percentage change from baseline was calculated.
6 secondary outcomes
Incidence of Hemidiaphragmatic Paralysis
Time frame: 30 minutes after block administration
Degree of Hemidiaphragmatic Paralysis
Time frame: 30 minutes after block administration
Block Performance Time
Time frame: From needle insertion to completion of the block procedure
Additional Intraoperative Analgesia Requirement
Time frame: From surgical incision to the end of surgery
Time to First Analgesic Requirement
Time frame: Up to 24 hours after surgery
Block-Related Complications
Time frame: From block administration until 24 hours after surgery
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 10 Jun 2026.
- Individual participant dataSharing planned: No. Individual participant data collected during the study will not be shared with other researchers because of institutional policies, ethical considerations, and protection of participant confidentiality.
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Diaphragm Ultrasound and Neuromuscular Monitoring for Predicting Early Respiratory Events After Extubation
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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 GUNGOR, 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?
An observational study of Diaphragmatic Excursion and Hemidiaphragmatic Paralysis, 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 12 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 10 Jun 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?
Change in Diaphragmatic Excursion at 30 Minutes After Block Administration (time frame: 30 minutes after block administration). 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 10 Jun 2026.