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Recruiting NCT07474896

Diaphragm-Sparing Regional Anesthesia Techniques for Shoulder Surgery

No phase Interventional Osteoarthritis Shoulder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ropivacaine 0.2% for Interscalene Block, Ropivacaine 0.2% for Infraclavicular and Suprascapular Nerve Blocks.
Who it may be relevant to
Registry conditions: Osteoarthritis Shoulder. Basic parameters: 65 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Poland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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

Overview

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.

Interventions

  • Drug Ropivacaine 0.2% for Interscalene 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
  • Drug Ropivacaine 0.2% for Infraclavicular and Suprascapular Nerve Blocks
    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

Primary outcome measures

  • Incidence of Hemidiaphragmatic Paresis [Time frame: before block and 30-60 minutes after block.]
Secondary outcome measures (12)
  • 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.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Poland · 1 center
  • Poznan University of Medical Sciences — Poznan

Identifiers

NCT: NCT07474896 · 12/2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗