Hemidiaphragmatic ParalysisNCT07486349
Shoulder Pericapsular Block Versus Interscalene Block in Arthroscopic Shoulder Surgery
A study testing Interscalene Nerve Block and shoulder pericapsular nerve group block in people with Hemidiaphragmatic Paralysis, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial aims to compare the incidence of hemidiaphragmatic paralysis (HDP) following ultrasound-guided interscalene block (ISB) versus shoulder pericapsular nerve group (PENG) block in patients undergoing elective shoulder surgery under general anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hemidiaphragmatic Paralysis
- What is being tested?
- Interscalene Nerve Block and shoulder pericapsular nerve group block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2026to 22 Oct 2026
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA physical status I-III
- Scheduled for elective shoulder surgery under general anesthesia
- Able to provide informed consent
Who cannot join
- Pre-existing diaphragmatic dysfunction
- Severe COPD or restrictive pulmonary disease
- Neuromuscular disorders
- BMI > 40 kg/m²
- Coagulopathy
- Infection at injection site
- Allergy to local anesthetics
- Inability to undergo diaphragmatic ultrasound assessment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound-Guided Interscalene Block Versus Shoulder Pericapsular Nerve Group (PENG) Block for Hemidiaphragmatic Paralysis in Elective Shoulder Surgery: A Randomized Controlled Trial
This randomized controlled trial aims to compare the incidence of hemidiaphragmatic paralysis (HDP) following ultrasound-guided interscalene block (ISB) versus shoulder pericapsular nerve group (PENG) block in patients undergoing elective shoulder surgery under general anesthesia.
The primary objective is to determine whether the shoulder PENG block reduces the incidence of HDP compared with conventional intrafascial ISB. HDP will be assessed using ultrasound measurement of diaphragmatic excursion 30 minutes after block performance
Read the detailed description
Interscalene block is widely used for shoulder surgery but is frequently associated with ipsilateral hemidiaphragmatic paralysis due to phrenic nerve involvement. The shoulder PENG block is a more distal pericapsular technique targeting articular branches and may reduce diaphragmatic impairment.
This prospective, parallel-group, randomized controlled trial will enroll 68 adult patients scheduled for elective shoulder surgery. Participants will be randomly assigned (1:1) to receive either ultrasound-guided intrafascial interscalene block or ultrasound-guided shoulder PENG block.
Both groups will receive 15 mL of 0.25% bupivacaine (total dose 37.5 mg). Diaphragmatic excursion will be measured at baseline and 30 minutes after block performance using M-mode ultrasonography by a blinded assessor.
The primary endpoint is hemidiaphragmatic paralysis defined as ≥25% reduction in diaphragmatic excursion from baseline. Partial and complete paralysis will be analyzed as a composite binary outcome.
- Conditions
- Hemidiaphragmatic Paralysis
- Being tested
- Interscalene Nerve Block, shoulder pericapsular nerve group block
- Keywords
- hemidiaphragmatic paralysis, intescalen block, shoulder pericapsular nerve group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interscalene Nerve BlockOther
Procedure: Ultrasound-guided conventional intrafascial interscalene block at C5-C6 level Drug: 15 mL of 0.25% bupivacaine (37.5 mg)
shoulder pericapsular nerve group blockOther
Procedure: Ultrasound-guided shoulder pericapsular nerve group block Drug: 15 mL of 0.25% bupivacaine (37.5 mg)
| Study group | Role | What they receive |
|---|---|---|
| Shoulder PENG Block | Active comparator | Procedure: Ultrasound-guided shoulder pericapsular nerve group block Drug: 15 mL of 0.25% bupivacaine (37.5 mg) Receives: Other: shoulder pericapsular nerve group block |
| Interscalene Block (ISB) | Active comparator | Procedure: Ultrasound-guided conventional intrafascial interscalene block at C5-C6 level Drug: 15 mL of 0.25% bupivacaine (37.5 mg) Receives: Other: Interscalene Nerve Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemidiaphragmatic Paralysis (HDP)
≥25% reduction in diaphragmatic excursion from baseline measured by ultrasound M-mode.
Measured: 30 minutes after block performance
Secondary outcomes (5)
Complete hemidiaphragmatic paralysis (≥75% reduction or paradoxical motion)
≥75% reduction or paradoxical motion
Measured: 30 minutes after block performance
Absolute and percentage change in diaphragmatic excursion
change in diaphragmatic excursion
Measured: 30 minutes after block performance
Total 24-hour tramadol consumption (mg)
Total 24-hour tramadol consumption (mg)
Measured: postoperative 24 hours
NRS pain scores (from 0 to 10: 0 stands for no pain, 10 stands for severe pain)
Postoperative pain scores
Measured: postopertaive 2 hours, 6 hours, 12 hours, 24 hours
Rescue morphine consumption (mg)
Rescue morphine consumption (mg)
Measured: postoperative 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2026
- Study start1 Apr 2026
- Primary completion22 Oct 2026
- Study completion22 Oct 2026
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 Marmara 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beliz Bilgili, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07486349
- Sponsor's protocol ID
- Shoulder Pericapsular Block
- Status last verified
- Feb 2026
- First submitted
- 24 Feb 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-Guided Interscalene Block Versus Shoulder Pericapsular Nerve Group (PENG) Block for Hemidiaphragmatic Paralysis in Elective Shoulder Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07486349
- Acronym / sponsor ID
- Shoulder Pericapsular Block
- Conditions
- Hemidiaphragmatic Paralysis
- Keywords
- hemidiaphragmatic paralysis, intescalen block, shoulder pericapsular nerve group
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 22 Oct 2026 (actual)
- Study completion
- 22 Oct 2026 (actual)
- First posted
- 20 Mar 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 controlled trial aims to compare the incidence of hemidiaphragmatic paralysis (HDP) following ultrasound-guided interscalene block (ISB) versus shoulder pericapsular nerve group (PENG) block in patients undergoing elective shoulder surgery under general anesthesia.
The primary objective is to determine whether the shoulder PENG block reduces the incidence of HDP compared with conventional intrafascial ISB. HDP will be assessed using ultrasound measurement of diaphragmatic excursion 30 minutes after block performance
Detailed description
Interscalene block is widely used for shoulder surgery but is frequently associated with ipsilateral hemidiaphragmatic paralysis due to phrenic nerve involvement. The shoulder PENG block is a more distal pericapsular technique targeting articular branches and may reduce diaphragmatic impairment.
This prospective, parallel-group, randomized controlled trial will enroll 68 adult patients scheduled for elective shoulder surgery. Participants will be randomly assigned (1:1) to receive either ultrasound-guided intrafascial interscalene block or ultrasound-guided shoulder PENG block.
Both groups will receive 15 mL of 0.25% bupivacaine (total dose 37.5 mg). Diaphragmatic excursion will be measured at baseline and 30 minutes after block performance using M-mode ultrasonography by a blinded assessor.
The primary endpoint is hemidiaphragmatic paralysis defined as ≥25% reduction in diaphragmatic excursion from baseline. Partial and complete paralysis will be analyzed as a composite binary outcome.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shoulder PENG Block | Active comparator | Other: shoulder pericapsular nerve group blockProcedure: Ultrasound-guided shoulder pericapsular nerve group block Drug: 15 mL of 0.25% bupivacaine (37.5 mg) |
| Interscalene Block (ISB) | Active comparator | Other: Interscalene Nerve BlockProcedure: Ultrasound-guided conventional intrafascial interscalene block at C5-C6 level Drug: 15 mL of 0.25% bupivacaine (37.5 mg) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA physical status I-III
- Scheduled for elective shoulder surgery under general anesthesia
- Able to provide informed consent
Key exclusion criteria (8 listed)
- Pre-existing diaphragmatic dysfunction
- Severe COPD or restrictive pulmonary disease
- Neuromuscular disorders
- BMI > 40 kg/m²
- Coagulopathy
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 |
|---|---|---|
| Interscalene Nerve BlockProcedure: Ultrasound-guided conventional intrafascial interscalene block at C5-C6 level Drug: 15 mL of 0.25% bupivacaine (37.5 mg) | Other | Interscalene Block (ISB) |
| shoulder pericapsular nerve group blockProcedure: Ultrasound-guided shoulder pericapsular nerve group block Drug: 15 mL of 0.25% bupivacaine (37.5 mg) | Other | Shoulder PENG Block |
Primary outcome
Hemidiaphragmatic Paralysis (HDP)
Time frame: 30 minutes after block performance
≥25% reduction in diaphragmatic excursion from baseline measured by ultrasound M-mode.
5 secondary outcomes
Complete hemidiaphragmatic paralysis (≥75% reduction or paradoxical motion)
Time frame: 30 minutes after block performance
Absolute and percentage change in diaphragmatic excursion
Time frame: 30 minutes after block performance
Total 24-hour tramadol consumption (mg)
Time frame: postoperative 24 hours
NRS pain scores (from 0 to 10: 0 stands for no pain, 10 stands for severe pain)
Time frame: postopertaive 2 hours, 6 hours, 12 hours, 24 hours
Rescue morphine consumption (mg)
Time frame: postoperative 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 23 Oct 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interscalene Nerve Block and shoulder pericapsular nerve group block in people with Hemidiaphragmatic Paralysis, run by Marmara 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 3 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 23 Oct 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?
Hemidiaphragmatic Paralysis (HDP) (time frame: 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 23 Oct 2026.