About this trial
This randomized controlled trial aims to compare the incidence of hemidiaphragmatic paralysis (HDP) following ultrasound-guided interscalene block (ISB) versus shoulder pericapsular nerve group (PENG) block in patients undergoing elective shoulder surgery under general anesthesia.
The primary objective is to determine whether the shoulder PENG block reduces the incidence of HDP compared with conventional intrafascial ISB. HDP will be assessed using ultrasound measurement of diaphragmatic excursion 30 minutes after block performance
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
ASA physical status I-III
Scheduled for elective shoulder surgery under general anesthesia
Able to provide informed consent
Disqualifiers
Pre-existing diaphragmatic dysfunction
Severe COPD or restrictive pulmonary disease
Neuromuscular disorders
BMI > 40 kg/m²
Trial design
Parallel
Treatments tested in this trial
Interscalene Nerve Block
Other interventionProcedure: Ultrasound-guided conventional intrafascial interscalene block at C5-C6 level Drug: 15 mL of 0.25% bupivacaine (37.5 mg)
shoulder pericapsular nerve group block
Other interventionProcedure: Ultrasound-guided shoulder pericapsular nerve group block Drug: 15 mL of 0.25% bupivacaine (37.5 mg)
Treatment groups
Trial outcomes
Primary outcomes
Hemidiaphragmatic Paralysis (HDP)
≥25% reduction in diaphragmatic excursion from baseline measured by ultrasound M-mode.
Secondary outcomes
Complete hemidiaphragmatic paralysis (≥75% reduction or paradoxical motion)
≥75% reduction or paradoxical motion
Absolute and percentage change in diaphragmatic excursion
change in diaphragmatic excursion
Total 24-hour tramadol consumption (mg)
Total 24-hour tramadol consumption (mg)
NRS pain scores (from 0 to 10: 0 stands for no pain, 10 stands for severe pain)
Postoperative pain scores
Sponsors and contacts
Click on the lead sponsor to view all of their trials.