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The study aims to evaluation the effects of Liposomal Bupivacaine on diaphragmatic function in patients undergoing upper limb surgery who receive Interscalene Brachial Plexus Block. A total of 120 eligible patients will be enrolled and divided into two groups: Group A will receive 20ml of 0.5% Hydrochloride Bupivacaine , while Group B will receive 10ml of 0.5% Hydrochloride Bupivacaine plus 10ml of Liposomal Bupivacaine. Assessments of diaphragmatic function, pulmonary function, and pain intensity will be performed before the block and at different time points after the block, with follow-up for adverse events. The study is scheduled to run from September 2025 to September 2026, with strict adherence to privacy protection and ethical guidelines.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group: 0.5% Hydrochloride Bupivacaine (10ml) + Liposomal Bupivacaine (10ml) for ISBPB | Experimental | ISBPB block group receiving combined administration of two drugs |
|
| 0.5% Hydrochloride Bupivacaine (20ml) for ISBPB | Active Comparator | ISBPB block control group receiving single administration of a single drug |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.5% Hydrochloride Bupivacaine 20ml | Drug | 0.5% Hydrochloride Bupivacaine 20ml for ISBPB |
|
| Measure | Description | Time Frame |
|---|---|---|
| Identification the recovery time of diaphragmatic function after diaphragmatic paralysis caused by interscalene brachial plexus block | From the initiation of interscalene brachial plexus block to the recovery of diaphragmatic function (within approximately 72 hours) |
| Measure | Description | Time Frame |
|---|---|---|
| Identification the recovery time of pulmonary function after diaphragmatic paralysis | From the initiation of interscalene brachial plexus block to the recovery of pulmonary function (within approximately 72 hours) | |
| Identification the Incidence of hemidiaphragmatic paralysis at different time points |
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Inclusion Criteria:
Exclusion Criteria:
Withdrawal Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Diansan Su, PhD | Contact | +8618616514088 | diansansu@yahoo.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, zhejiang 310000 | Hangzhou | Zhejiang | 310000 | China |
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| 0.5% Hydrochloride Bupivacaine 10ml | Drug | 0.5% Hydrochloride Bupivacaine 10ml for ISBPB |
|
| Liposomal Bupivacaine 10mL | Drug | Liposomal Bupivacaine 10mL for ISBPB |
|
| From the initiation of interscalene brachial plexus block to the recovery of diaphragmatic function (within approximately 72 hours) |
| Identification the Proportion of pulmonary function recovery | Time Frame: From the initiation of interscalene brachial plexus block to the recovery of pulmonary function (within approximately 72 hours) |
| ID | Term |
|---|---|
| D011885 | Radius Fractures |
| ID | Term |
|---|---|
| D005543 | Forearm Injuries |
| D001134 | Arm Injuries |
| D014947 | Wounds and Injuries |
| D050723 | Fractures, Bone |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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