Diaphragm-Sparing Regional Anesthesia Techniques for Shoulder Surgery

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат 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
• Препарат 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

Первичные конечные точки

• Incidence of Hemidiaphragmatic Paresis [Срок оценки: before block and 30-60 minutes after block.]

Вторичные конечные точки (12)

• Pain Scores at Rest (NRS 0-10) [Срок оценки: 2 hours postoperatively]
• Pain Scores at Rest (NRS 0-10) [Срок оценки: 6 hours postoperatively]
• Pain Scores at Rest (NRS 0-10) [Срок оценки: 12 hours postoperatively]
• Pain Scores at Rest (NRS 0-10) [Срок оценки: 24 hours postoperatively]
• Pain Scores at Rest (NRS 0-10) [Срок оценки: 48 hours postoperatively]
• Pain Scores During Movement (NRS 0-10) [Срок оценки: 2 hours postoperatively]
• Pain Scores During Movement (NRS 0-10) [Срок оценки: 6 hours postoperatively]
• Pain Scores During Movement (NRS 0-10) [Срок оценки: 12 hours postoperatively]
• Pain Scores During Movement (NRS 0-10) [Срок оценки: 24 hours postoperatively]
• Pain Scores During Movement (NRS 0-10) [Срок оценки: 48 hours postoperatively]
• Total Opioid Consumption [Срок оценки: Within 24 hours after surgery.]
• Block-Related Adverse Events [Срок оценки: From block placement until 30 days after surgery.]

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Польша · 1 центр

• Poznan University of Medical Sciences — Poznan

Идентификаторы

NCT: NCT07474896 · 12/2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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