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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Shoulder PENG Block | Active Comparator | Procedure: Ultrasound-guided shoulder pericapsular nerve group block Drug: 15 mL of 0.25% bupivacaine (37.5 mg) |
|
| Interscalene Block (ISB) | Active Comparator | Procedure: Ultrasound-guided conventional intrafascial interscalene block at C5-C6 level Drug: 15 mL of 0.25% bupivacaine (37.5 mg) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interscalene Nerve Block | Other | Procedure: Ultrasound-guided conventional intrafascial interscalene block at C5-C6 level Drug: 15 mL of 0.25% bupivacaine (37.5 mg) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hemidiaphragmatic Paralysis (HDP) | ≥25% reduction in diaphragmatic excursion from baseline measured by ultrasound M-mode. | 30 minutes after block performance |
| Measure | Description | Time Frame |
|---|---|---|
| Complete hemidiaphragmatic paralysis (≥75% reduction or paradoxical motion) | ≥75% reduction or paradoxical motion | 30 minutes after block performance |
| Absolute and percentage change in diaphragmatic excursion |
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Inclusion Criteria:
Exclusion Criteria:
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| shoulder pericapsular nerve group block | Other | Procedure: Ultrasound-guided shoulder pericapsular nerve group block Drug: 15 mL of 0.25% bupivacaine (37.5 mg) |
|
change in diaphragmatic excursion
| 30 minutes after block performance |
| Total 24-hour tramadol consumption (mg) | Total 24-hour tramadol consumption (mg) | postoperative 24 hours |
| NRS pain scores (from 0 to 10: 0 stands for no pain, 10 stands for severe pain) | Postoperative pain scores | postopertaive 2 hours, 6 hours, 12 hours, 24 hours |
| Rescue morphine consumption (mg) | Rescue morphine consumption (mg) | postoperative 24 hours |