Osteoarthritis ShoulderNCT07474896
Diaphragm-Sparing Regional Anesthesia Techniques for Shoulder Surgery
A study testing Ropivacaine 0.2% for Interscalene Block and Ropivacaine 0.2% for Infraclavicular and Suprascapular Nerve Blocks in people with Osteoarthritis Shoulder, run by Poznan University of Medical Sciences at 1 site in Poland.
Trial summary
This study will compare two regional anesthesia techniques for shoulder surgery and evaluate their effects on diaphragmatic function. The standard regional anesthesia technique for shoulder surgery is the interscalene brachial plexus block (ISB), which provides effective analgesia but is frequently associated with… Read more about this study
- Who is it for?
- Ages 65 to 100 years
- Conditions the study is for
- Osteoarthritis Shoulder
- What is being tested?
- Ropivacaine 0.2% for Interscalene Block and Ropivacaine 0.2% for Infraclavicular and Suprascapular Nerve Blocks
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 sitePoland
- Study dates
- 10 Dec 2025to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age ≥ 65 years
- Elective shoulder surgery
- ASA I-III
- Planned use of regional anesthesia
- Signed written informed consent
Who cannot join
- Allergy to local anesthetics
- Planned continuous catheter technique
- BMI >40 kg/m²
- Coagulopathy or anticoagulation
- Pre-existing phrenic nerve palsy
- Neurological disorder of the operative limb
- Pregnancy or breastfeeding
- Participation in another clinical trial within 30 days
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Poznan University of Medical Sciences
Poznan, 62-701
Malgorzata Reysner, M.D. Ph.D., +48 61 873 83 03, mreysner@ump.edu.pl
About this study
Official title: Comparison of Interscalene Brachial Plexus Block Versus the Combination of Suprascapular and Infraclavicular Brachial Plexus Block for Shoulder Surgery: A Randomized Controlled Trial With Diaphragmatic Function Assessment
This study will compare two regional anesthesia techniques for shoulder surgery and evaluate their effects on diaphragmatic function. The standard regional anesthesia technique for shoulder surgery is the interscalene brachial plexus block (ISB), which provides effective analgesia but is frequently associated with ipsilateral hemidiaphragmatic paresis due to phrenic nerve involvement.
An alternative diaphragm-sparing strategy is the combination of a suprascapular nerve block (SSNB) and an infraclavicular brachial plexus block (ICB), which may reduce the risk of diaphragmatic dysfunction while maintaining effective analgesia for shoulder surgery.
Read more
All participants will receive ultrasound-guided regional anesthesia prior to surgery and will be randomly assigned to one of two groups:
Group 1: Interscalene brachial plexus block Group 2: Suprascapular nerve block combined with infraclavicular brachial plexus block The primary aim of this study is to determine whether the diaphragm-sparing technique reduces the incidence of hemidiaphragmatic paresis while providing analgesia comparable to the standard interscalene block. Diaphragmatic movement will be assessed using ultrasound before and after block placement. Secondary outcomes include postoperative pain intensity, opioid consumption, pulmonary function parameters, and block-related complications.
Read the detailed description
The interscalene brachial plexus block (ISB) is widely used for anesthesia and postoperative analgesia in shoulder surgery because of its reliable and effective pain control. However, ISB is commonly associated with ipsilateral hemidiaphragmatic paresis due to unintended phrenic nerve blockade, which may impair respiratory function, particularly in older patients and in those with pre-existing pulmonary disease.
The combination of a suprascapular nerve block (SSNB) and an infraclavicular brachial plexus block (ICB) has been proposed as a diaphragm-sparing alternative for shoulder surgery. This approach may provide adequate surgical anesthesia and postoperative analgesia while minimizing the risk of diaphragmatic dysfunction.
This randomized controlled trial will compare the interscalene brachial plexus block with the combined suprascapular and infraclavicular brachial plexus block in patients undergoing elective shoulder surgery. Diaphragmatic function will be evaluated using ultrasound imaging before block performance and after block placement. Additional outcomes will include postoperative pain intensity at rest and during movement, opioid consumption, pulmonary function parameters, block-related complications, length of hospital stay, and patient satisfaction.
- Conditions
- Osteoarthritis Shoulder
- Being tested
- Ropivacaine 0.2% for Interscalene Block, Ropivacaine 0.2% for Infraclavicular and Suprascapular Nerve Blocks
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropivacaine 0.2% for Interscalene BlockDrug
Also called interscalene brachial plexus block
Participants in this arm will receive an ultrasound-guided interscalene brachial plexus block using 20 mL of 0.2% ropivacaine. The block will be performed as a single-shot injection prior to shoulder surgery. No suprascapular or infraclavicular block will be performed in this group
Ropivacaine 0.2% for Infraclavicular and Suprascapular Nerve BlocksDrug
Also called Infraclavicular brachial plexus block + Suprascapular nerve block
Participants in this arm will receive two ultrasound-guided peripheral nerve blocks as part of the diaphragm-sparing strategy:
Infraclavicular brachial plexus block: 15 mL of 0.2% ropivacaine Suprascapular nerve block: 5 mL of 0.2% ropivacaine Both injections will be performed as single-shot blocks prior to surgery. No interscalene block will be performed in this arm
| Study group | Role | What they receive |
|---|---|---|
| Interscalene Block (ISB) | Active comparator | Participants will receive a single-shot ultrasound-guided interscalene block using 20 mL of 0.2% ropivacaine. Receives: Drug: Ropivacaine 0.2% for Interscalene Block |
| Infraclavicular Block (ICB) + Suprascapular Nerve Block (SSNB) | Active comparator | Participants will receive two ultrasound-guided single-shot peripheral nerve blocks:
* Infraclavicular brachial plexus block: 15 mL of 0.2% ropivacaine
* Suprascapular nerve block: 5 mL of 0.2% ropivacaine
All blocks will be performed under ultrasound guidance. Receives: Drug: Ropivacaine 0.2% for Infraclavicular and Suprascapular Nerve Blocks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Hemidiaphragmatic Paresis
Incidence of hemidiaphragmatic paresis, defined as a >75% reduction in diaphragmatic excursion or paradoxical movement on ultrasound M-mode compared with baseline.
Measured: before block and 30-60 minutes after block.
Secondary outcomes (15)
Pain Scores at Rest (NRS 0-10)
Pain intensity at rest measured using the 0-10 Numerical Rating Scale (0 = no pain, 10 = worst imaginable pain). Pain scores will be recorded at 2, 6, 12, 24, and 48 hours after surgery and analyzed as repeated measures over time.
Measured: 2 hours postoperatively
Pain Scores at Rest (NRS 0-10)
Pain intensity at rest measured using the 0-10 Numerical Rating Scale (0 = no pain, 10 = worst imaginable pain). Pain scores will be recorded at 2, 6, 12, 24, and 48 hours after surgery and analyzed as repeated measures over time.
Measured: 6 hours postoperatively
Pain Scores at Rest (NRS 0-10)
Pain intensity at rest measured using the 0-10 Numerical Rating Scale (0 = no pain, 10 = worst imaginable pain). Pain scores will be recorded at 2, 6, 12, 24, and 48 hours after surgery and analyzed as repeated measures over time.
Measured: 12 hours postoperatively
Pain Scores at Rest (NRS 0-10)
Pain intensity at rest measured using the 0-10 Numerical Rating Scale (0 = no pain, 10 = worst imaginable pain). Pain scores will be recorded at 2, 6, 12, 24, and 48 hours after surgery and analyzed as repeated measures over time.
Measured: 24 hours postoperatively
Pain Scores at Rest (NRS 0-10)
Pain intensity at rest measured using the 0-10 Numerical Rating Scale (0 = no pain, 10 = worst imaginable pain). Pain scores will be recorded at 2, 6, 12, 24, and 48 hours after surgery and analyzed as repeated measures over time.
Measured: 48 hours postoperatively
Pain Scores During Movement (NRS 0-10)
Pain intensity during passive or assisted shoulder movement measured using the 0-10 Numerical Rating Scale (0 = no pain, 10 = worst imaginable pain). Mean values at each time point will be compared between groups.
Measured: 2 hours postoperatively
Pain Scores During Movement (NRS 0-10)
Pain intensity during passive or assisted shoulder movement measured using the 0-10 Numerical Rating Scale (0 = no pain, 10 = worst imaginable pain). Mean values at each time point will be compared between groups.
Measured: 6 hours postoperatively
Pain Scores During Movement (NRS 0-10)
Pain intensity during passive or assisted shoulder movement measured using the 0-10 Numerical Rating Scale (0 = no pain, 10 = worst imaginable pain). Mean values at each time point will be compared between groups.
Measured: 12 hours postoperatively
Pain Scores During Movement (NRS 0-10)
Pain intensity during passive or assisted shoulder movement measured using the 0-10 Numerical Rating Scale (0 = no pain, 10 = worst imaginable pain). Mean values at each time point will be compared between groups.
Measured: 24 hours postoperatively
Pain Scores During Movement (NRS 0-10)
Pain intensity during passive or assisted shoulder movement measured using the 0-10 Numerical Rating Scale (0 = no pain, 10 = worst imaginable pain). Mean values at each time point will be compared between groups.
Measured: 48 hours postoperatively
Total Opioid Consumption
Cumulative dose of opioid analgesics administered during the postoperative period, converted to oral morphine milligram equivalents (MME), will be recorded and compared between groups.
Measured: Within 24 hours after surgery.
Block-Related Adverse Events
Incidence of complications related to the regional anesthesia technique, including local anesthetic systemic toxicity (LAST), prolonged sensory or motor deficit, hematoma, infection at the injection site, or nerve injury. Neurological assessment may be performed in the outpatient clinic if required.
Measured: From block placement until 30 days after surgery.
Oxygen Saturation (SpO₂)
The lowest recorded peripheral oxygen saturation (SpO₂, %) during the first 24 hours after surgery will be compared between groups.
Measured: From block performance until 24 hours after surgery.
Respiratory rate (breaths per minute).
The highest recorded respiratory rate during the first 24 hours after surgery will be compared between groups.
Measured: From block performance until 24 hours after surgery.
Incidence of oxygen desaturation (SpO₂ < 92%)
Oxygen desaturation will be defined as the occurrence of at least one episode of peripheral oxygen saturation (SpO₂) < 92%, measured by pulse oximetry, during the first 24 hours after surgery. The outcome will be analyzed as a binary variable (presence or absence of oxygen desaturation).
Measured: From block performance 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 posted16 Mar 2026
- Study start10 Dec 2025
- Primary completion1 Jan 2027 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis ShoulderStudies of the same condition, open and under way.
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poznan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Malgorzata Reysner, MD PhD, Study chair, Poznan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07474896
- Sponsor's protocol ID
- 12/2025
- Status last verified
- Apr 2026
- First submitted
- 4 Dec 2025
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: demographics, outcomes, complications.
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Interscalene Brachial Plexus Block Versus the Combination of Suprascapular and Infraclavicular Brachial Plexus Block for Shoulder Surgery: A Randomized Controlled Trial With Diaphragmatic Function Assessment
- ClinicalTrials.gov ID
- NCT07474896
- Acronym / sponsor ID
- 12/2025
- Conditions
- Osteoarthritis Shoulder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Poznan University of Medical SciencesUniversity, hospital or other
- Study start
- 10 Dec 2025 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 16 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 study will compare two regional anesthesia techniques for shoulder surgery and evaluate their effects on diaphragmatic function. The standard regional anesthesia technique for shoulder surgery is the interscalene brachial plexus block (ISB), which provides effective analgesia but is frequently associated with ipsilateral hemidiaphragmatic paresis due to phrenic nerve involvement.
An alternative diaphragm-sparing strategy is the combination of a suprascapular nerve block (SSNB) and an infraclavicular brachial plexus block (ICB), which may reduce the risk of diaphragmatic dysfunction while maintaining effective analgesia for shoulder surgery.
All participants will receive ultrasound-guided regional anesthesia prior to surgery and will be randomly assigned to one of two groups:
Group 1: Interscalene brachial plexus block Group 2: Suprascapular nerve block combined with infraclavicular brachial plexus block The primary aim of this study is to determine whether the diaphragm-sparing technique reduces the incidence of hemidiaphragmatic paresis while providing analgesia comparable to the standard interscalene block. Diaphragmatic movement will be assessed using ultrasound before and after block placement. Secondary outcomes include postoperative pain intensity, opioid consumption, pulmonary function parameters, and block-related complications.
Detailed description
The interscalene brachial plexus block (ISB) is widely used for anesthesia and postoperative analgesia in shoulder surgery because of its reliable and effective pain control. However, ISB is commonly associated with ipsilateral hemidiaphragmatic paresis due to unintended phrenic nerve blockade, which may impair respiratory function, particularly in older patients and in those with pre-existing pulmonary disease.
The combination of a suprascapular nerve block (SSNB) and an infraclavicular brachial plexus block (ICB) has been proposed as a diaphragm-sparing alternative for shoulder surgery. This approach may provide adequate surgical anesthesia and postoperative analgesia while minimizing the risk of diaphragmatic dysfunction.
This randomized controlled trial will compare the interscalene brachial plexus block with the combined suprascapular and infraclavicular brachial plexus block in patients undergoing elective shoulder surgery. Diaphragmatic function will be evaluated using ultrasound imaging before block performance and after block placement. Additional outcomes will include postoperative pain intensity at rest and during movement, opioid consumption, pulmonary function parameters, block-related complications, length of hospital stay, and patient satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interscalene Block (ISB) | Active comparator | Drug: Ropivacaine 0.2% for Interscalene BlockParticipants will receive a single-shot ultrasound-guided interscalene block using 20 mL of 0.2% ropivacaine. |
| Infraclavicular Block (ICB) + Suprascapular Nerve Block (SSNB) | Active comparator | Drug: Ropivacaine 0.2% for Infraclavicular and Suprascapular Nerve BlocksParticipants will receive two ultrasound-guided single-shot peripheral nerve blocks: * Infraclavicular brachial plexus block: 15 mL of 0.2% ropivacaine * Suprascapular nerve block: 5 mL of 0.2% ropivacaine All blocks will be performed under ultrasound guidance. |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Age ≥ 65 years
- Elective shoulder surgery
- ASA I-III
- Planned use of regional anesthesia
- Signed written informed consent
Key exclusion criteria (8 listed)
- Allergy to local anesthetics
- Planned continuous catheter technique
- BMI >40 kg/m²
- Coagulopathy or anticoagulation
- Pre-existing phrenic nerve palsy
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 |
|---|---|---|
| Ropivacaine 0.2% for Interscalene BlockAlso: interscalene brachial plexus blockParticipants in this arm will receive an ultrasound-guided interscalene brachial plexus block using 20 mL of 0.2% ropivacaine. The block will be performed as a single-shot injection prior to shoulder surgery. No suprascapular or infraclavicular block will be performed in this group | Drug | Interscalene Block (ISB) |
| Ropivacaine 0.2% for Infraclavicular and Suprascapular Nerve BlocksAlso: Infraclavicular brachial plexus block + Suprascapular nerve blockParticipants in this arm will receive two ultrasound-guided peripheral nerve blocks as part of the diaphragm-sparing strategy: Infraclavicular brachial plexus block: 15 mL of 0.2% ropivacaine Suprascapular nerve block: 5 mL of 0.2% ropivacaine Both injections will be performed as single-shot blocks prior to surgery. No interscalene block will be performed in this arm | Drug | Infraclavicular Block (ICB) + Suprascapular Nerve Block (SSNB) |
Primary outcome
Incidence of Hemidiaphragmatic Paresis
Time frame: before block and 30-60 minutes after block.
Incidence of hemidiaphragmatic paresis, defined as a >75% reduction in diaphragmatic excursion or paradoxical movement on ultrasound M-mode compared with baseline.
15 secondary outcomes
Pain Scores at Rest (NRS 0-10)
Time frame: 2 hours postoperatively
Pain Scores at Rest (NRS 0-10)
Time frame: 6 hours postoperatively
Pain Scores at Rest (NRS 0-10)
Time frame: 12 hours postoperatively
Pain Scores at Rest (NRS 0-10)
Time frame: 24 hours postoperatively
Pain Scores at Rest (NRS 0-10)
Time frame: 48 hours postoperatively
Pain Scores During Movement (NRS 0-10)
Time frame: 2 hours postoperatively
Pain Scores During Movement (NRS 0-10)
Time frame: 6 hours postoperatively
Pain Scores During Movement (NRS 0-10)
Time frame: 12 hours postoperatively
Pain Scores During Movement (NRS 0-10)
Time frame: 24 hours postoperatively
Pain Scores During Movement (NRS 0-10)
Time frame: 48 hours postoperatively
Total Opioid Consumption
Time frame: Within 24 hours after surgery.
Block-Related Adverse Events
Time frame: From block placement until 30 days after surgery.
Oxygen Saturation (SpO₂)
Time frame: From block performance until 24 hours after surgery.
Respiratory rate (breaths per minute).
Time frame: From block performance until 24 hours after surgery.
Incidence of oxygen desaturation (SpO₂ < 92%)
Time frame: From block performance until 24 hours after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: Yes. demographics, outcomes, complications.
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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.
Malgorzata Reysner, MD PhD study chair
Poznan University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ropivacaine 0.2% for Interscalene Block and Ropivacaine 0.2% for Infraclavicular and Suprascapular Nerve Blocks in people with Osteoarthritis Shoulder, run by Poznan University of Medical Sciences at 1 site in Poland.
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 5 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: looking for participants now, as of the sponsor's last update on 22 May 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 Poland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Malgorzata Reysner, MD PhD (+48618738313, mreysner@ump.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Hemidiaphragmatic Paresis (time frame: before block and 30-60 minutes after block.). 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 22 May 2026.