Diaphragm-Sparing Regional Anesthesia Techniques for Shoulder Surgery
ConditionOsteoarthritis Shoulder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65-100
SponsorPoznan University of Medical Sciences
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 65 years
Elective shoulder surgery
ASA I-III
Planned use of regional anesthesia
Disqualifiers
Allergy to local anesthetics
Planned continuous catheter technique
BMI >40 kg/m²
Coagulopathy or anticoagulation
Trial design
Design model
Parallel
Treatments tested in this trial
Ropivacaine 0.2% for Interscalene Block
DrugParticipants 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 Blocks
DrugParticipants 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
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: Interscalene Block (ISB)Active comparator 1 intervention
Group B: Infraclavicular Block (ICB) + Suprascapular Nerve Block (SSNB)Active comparator 1 intervention
Trial outcomes
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.
Time frame
before block and 30-60 minutes after block.Secondary outcomes
1
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.
Time frame
2 hours postoperatively2
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.
Time frame
6 hours postoperatively3
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.
Time frame
12 hours postoperatively4
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.
Time frame
24 hours postoperativelySponsors and contacts
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Source ClinicalTrials.gov