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NCT Number: NCT07474896

Diaphragm-Sparing Regional Anesthesia Techniques for Shoulder Surgery

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.

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Key information

Conditions

Osteoarthritis Shoulder

Age range

65 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Poznan University of Medical Sciences

Poznan, 62-701, Poland

Location status: Recruiting

Location contact

Malgorzata Reysner, M.D. Ph.D.

CONTACT

[email protected]

+48 61 873 83 03

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 65 years
  • Elective shoulder surgery
  • ASA I-III
  • Planned use of regional anesthesia
  • Signed written informed consent

Exclusion criteria

  • 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

Treatment and study plan

Ropivacaine 0.2% for Interscalene Block

Drug

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

Other names: interscalene brachial plexus block

Ropivacaine 0.2% for Infraclavicular and Suprascapular Nerve Blocks

Drug

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

Other names: Infraclavicular brachial plexus block + Suprascapular nerve block

Primary outcomes

  1. 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.

Secondary outcomes

  1. Pain Scores at Rest (NRS 0-10)

    Time frame: 2 hours postoperatively

    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.

  2. Pain Scores at Rest (NRS 0-10)

    Time frame: 6 hours postoperatively

    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.

  3. Pain Scores at Rest (NRS 0-10)

    Time frame: 12 hours postoperatively

    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.

  4. Pain Scores at Rest (NRS 0-10)

    Time frame: 24 hours postoperatively

    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.

  5. Pain Scores at Rest (NRS 0-10)

    Time frame: 48 hours postoperatively

    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.

  6. Pain Scores During Movement (NRS 0-10)

    Time frame: 2 hours postoperatively

    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.

  7. Pain Scores During Movement (NRS 0-10)

    Time frame: 6 hours postoperatively

    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.

  8. Pain Scores During Movement (NRS 0-10)

    Time frame: 12 hours postoperatively

    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.

  9. Pain Scores During Movement (NRS 0-10)

    Time frame: 24 hours postoperatively

    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.

  10. Pain Scores During Movement (NRS 0-10)

    Time frame: 48 hours postoperatively

    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.

  11. Total Opioid Consumption

    Time frame: Within 24 hours after surgery.

    Cumulative dose of opioid analgesics administered during the postoperative period, converted to oral morphine milligram equivalents (MME), will be recorded and compared between groups.

  12. Block-Related Adverse Events

    Time frame: From block placement until 30 days after surgery.

    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.

  13. Oxygen Saturation (SpO₂)

    Time frame: From block performance until 24 hours after surgery.

    The lowest recorded peripheral oxygen saturation (SpO₂, %) during the first 24 hours after surgery will be compared between groups.

  14. Respiratory rate (breaths per minute).

    Time frame: From block performance until 24 hours after surgery.

    The highest recorded respiratory rate during the first 24 hours after surgery will be compared between groups.

  15. Incidence of oxygen desaturation (SpO₂ < 92%)

    Time frame: From block performance until 24 hours after surgery

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Malgorzata Reysner, MD PhD

CONTACT

[email protected]

+48618738313

Sponsors and collaborators

Lead sponsor

Poznan University of Medical Sciences

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 16, 2026
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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