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This single-center, prospective, single-arm, Bayesian phase I/II clinical trial evaluates the incidence of HDP following ISB in shoulder arthroscopy and determines the optimal volume of a single injection of liposomal bupivacaine.
Based on the ISB being the optimal nerve block for post-arthroscopic shoulder surgery analgesia and the potent analgesic effect of bupivacaine liposomes, this study aims to explore the optimal volume of a single ISB injection of bupivacaine liposomes in shoulder arthroscopy using the Bayesian Optimal Interval Design, with the goal of achieving the same analgesic effect while minimizing the incidence and duration of HDP to the greatest extent.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interscalene brachial plexus block |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine Liposomes(BL) | Drug | Prior to surgery, an interscalene brachial plexus block was performed, injecting the preset volume of 0.5% bupivacaine liposomes according to the Bayesian optimal interval method. |
| Measure | Description | Time Frame |
|---|---|---|
| Hemidiaphragmatic paresis incidence rate(Phase â… ) | The diaphragmatic excursion was measured using ultrasound 0.5 hours after the completion of the nerve block, and partial or complete unilateral Hemidiaphragmatic paresis(HDP) was assessed based on the diaphragmatic excursion. No excursion was defined as ≤25%, partial excursion as >25% and ≤75%, and complete excursion as >75%. A diaphragmatic excursion greater than or equal to 25% measured by ultrasound can be defined as HDP. | Perioperative |
| Success rate of interscalene brachial plexus block (Phase II) | Before the surgery, an ultrasound-guided interscalene brachial plexus block is performed. After the surgery, when the patient is fully awake, a simplified sensory-motor assessment scale is used for evaluation. A comprehensive score of ≥12 is defined as a successful nerve block. | Perioperative |
| Measure | Description | Time Frame |
|---|---|---|
| Hemidiaphragmatic paresis incidence rate | The diaphragmatic excursion was measured using ultrasound 6 hours and 24 hours after the completion of the nerve block, and partial or complete unilateral Hemidiaphragmatic paresis(HDP) was assessed based on the diaphragmatic excursion. No excursion was defined as ≤25%, partial excursion as >25% and ≤75%, and complete excursion as >75%. A diaphragmatic excursion greater than or equal to 25% measured by ultrasound can be defined as HDP. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients scheduled for elective arthroscopic shoulder surgery at Jiaxing University Affiliated Hospital.
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| Name | Affiliation | Role |
|---|---|---|
| Mingzi An, MD | Jiaxing University Affiliated Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jiaxing University Affiliated Hospital | Jiaxing | Zhejiang | 314000 | China |
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| Perioperative |
| Lung function | Lung function parameters, including tidal volume, vital capacity, and forced vital capacity, were measured bedside using a portable respiratory function monitor at 0.5 hours, 6 hours, and 24 hours after nerve block. | Perioperative |