Chronic Ulcer, Diaphragmatic Function, Metacarpal Fracture, Peripheral Nerve Neurolysis, Radius Fracture, Upper Extremity Ligament Injury
Conditions
Keywords
Interscalene brachial plexus block, Liposomal Bupivacaine, Hemidiaphragmatic paralysis
Brief summary
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.
Interventions
DRUG0.5% Hydrochloride Bupivacaine 20ml
0.5% Hydrochloride Bupivacaine 20ml for ISBPB
DRUG0.5% Hydrochloride Bupivacaine 10ml
0.5% Hydrochloride Bupivacaine 10ml for ISBPB
DRUGLiposomal Bupivacaine 10mL
Liposomal Bupivacaine 10mL for ISBPB
Sponsors
Zhejiang University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
Patients and all outcome assessors responsible for diaphragmatic electromyography, pulmonary function testing, and pain score assessment were blinded to group allocation. Anesthesiologists performing the interscalene brachial plexus block and administering the study solutions were not blinded, due to the distinguishable appearance of the study formulations and the nature of the interventional procedure.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients undergoing upper limb surgery scheduled for interscalene brachial plexus block * Aged ≥ 18 years * American Society of Anesthesiologists (ASA) physical status I-III
Exclusion criteria
* Known allergy or intolerance to amide local anesthetics * Nerve injury in the upper limb on the surgical side * Coagulopathy * Used opioid medications continuously for more than 3 weeks before surgery * History of pulmonary disease and a pulse oxygen saturation (SpO₂) \< 95% (measured after 5 minutes of rest at room temperature without oxygen supplementation, using a transcutaneous pulse oximeter) * Refuse to participate or are deemed unsuitable for this trial by the researchers Withdrawal Criteria: * Patients voluntarily withdrew their informed consent * Surgery was canceled or the anesthesia method was changed due to surgical factors before interscalene brachial plexus block
Design outcomes
Primary
| Measure | 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) |
Secondary
| Measure | 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 | 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) |
Countries
China
Contacts
CONTACTDiansan Su
Outcome results
None listed