Interscalene Nerve Block
OtherProcedure: Ultrasound-guided conventional intrafascial interscalene block at C5-C6 level Drug: 15 mL of 0.25% bupivacaine (37.5 mg)
NCT Number: NCT07486349
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
Trial opening soon.
Get Notified18 year–75 year
All sexes
Interventional
Not applicable
Interscalene block is widely used for shoulder surgery but is frequently associated with ipsilateral hemidiaphragmatic paralysis due to phrenic nerve involvement. The shoulder PENG block is a more distal pericapsular technique targeting articular branches and may reduce diaphragmatic impairment.
This prospective, parallel-group, randomized controlled trial will enroll 68 adult patients scheduled for elective shoulder surgery. Participants will be randomly assigned (1:1) to receive either ultrasound-guided intrafascial interscalene block or ultrasound-guided shoulder PENG block.
Both groups will receive 15 mL of 0.25% bupivacaine (total dose 37.5 mg). Diaphragmatic excursion will be measured at baseline and 30 minutes after block performance using M-mode ultrasonography by a blinded assessor.
The primary endpoint is hemidiaphragmatic paralysis defined as ≥25% reduction in diaphragmatic excursion from baseline. Partial and complete paralysis will be analyzed as a composite binary outcome.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Procedure: Ultrasound-guided conventional intrafascial interscalene block at C5-C6 level Drug: 15 mL of 0.25% bupivacaine (37.5 mg)
Procedure: Ultrasound-guided shoulder pericapsular nerve group block Drug: 15 mL of 0.25% bupivacaine (37.5 mg)
Time frame: 30 minutes after block performance
≥25% reduction in diaphragmatic excursion from baseline measured by ultrasound M-mode.
Time frame: 30 minutes after block performance
≥75% reduction or paradoxical motion
Time frame: 30 minutes after block performance
change in diaphragmatic excursion
Time frame: postoperative 24 hours
Total 24-hour tramadol consumption (mg)
Time frame: postopertaive 2 hours, 6 hours, 12 hours, 24 hours
Postoperative pain scores
Time frame: postoperative 24 hours
Rescue morphine consumption (mg)
Marmara University
Other
Ultrasound-Guided Interscalene Block Versus Shoulder Pericapsular Nerve Group (PENG) Block for Hemidiaphragmatic Paralysis in Elective Shoulder Surgery: A Randomized Controlled Trial
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