Diaphragm-Sparing Regional Anesthesia Techniques for Shoulder Surgery

NCT07474896 | Recruiting

• 1 other identifier: 12/2025
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Osteoarthritis Shoulder

Outcome Measures

Primary Outcomes (1)

• 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.

  before block and 30-60 minutes after block.

Secondary Outcomes (15)

• Pain Scores at Rest (NRS 0-10)

  2 hours postoperatively

• Pain Scores at Rest (NRS 0-10)

  6 hours postoperatively

• Pain Scores at Rest (NRS 0-10)

  12 hours postoperatively

• Pain Scores at Rest (NRS 0-10)

  24 hours postoperatively

• Pain Scores at Rest (NRS 0-10)

  48 hours postoperatively

Study Arms (2)

Interscalene Block (ISB)

ACTIVE COMPARATOR

Participants will receive a single-shot ultrasound-guided interscalene block using 20 mL of 0.2% ropivacaine.

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.

Drug: Ropivacaine 0.2% for Infraclavicular and Suprascapular Nerve Blocks

Interventions

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

Also known as: Infraclavicular brachial plexus block + Suprascapular nerve block

Infraclavicular Block (ICB) + Suprascapular Nerve Block (SSNB)

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

Also known as: interscalene brachial plexus block

Interscalene Block (ISB)

Eligibility Criteria

• Age: 65 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Poznan University of Medical Sciences: lead

Study Sites (1)

Poznan University of Medical Sciences

Poznan, 62-701, Poland

RECRUITING

MeSH Terms

Interventions

Ropivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Malgorzata Reysner, MD PhD

  Poznan University of Medical Sciences

  STUDY CHAIR

Central Study Contacts

Malgorzata Reysner, MD PhD

CONTACT

+48618738313; mreysner@ump.edu.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2025
• First Posted: March 16, 2026
• Study Start: December 10, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 31, 2027
• Last Updated: May 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 12 months after publication for 5 years.
• Access Criteria: reasonable request with DUA.

Locations

PL (1)