Determination of the Optimal Volume of 0.5% Bupivacaine Liposome in Single-Injection Interscalene Brachial Plexus Block: A Bayesian Phase I/II Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Bupivacaine Liposomes(BL).
- Who it may be relevant to
- Registry conditions: Shoulder Arthroscopy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
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.
Interventions
- Drug Bupivacaine Liposomes(BL)
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.
Primary outcome measures
- Hemidiaphragmatic paresis incidence rate(Phase Ⅰ) [Time frame: Perioperative]
- Success rate of interscalene brachial plexus block (Phase II) [Time frame: Perioperative]
Secondary outcome measures (2)
- Hemidiaphragmatic paresis incidence rate [Time frame: Perioperative]
- Lung function [Time frame: Perioperative]
Eligibility criteria
Inclusion criteria
- Patients aged 18 years and above;
- ASA classification I-III;
- Undergoing arthroscopic rotator cuff repair, capsular tightening, acromioplasty, synovectomy,.
Exclusion criteria
- History of pulmonary disease;
- Abnormal coagulation function or coagulation disorders;
- History of local anesthetic allergy;
- Infection, lesion, or history of cervical disease at the block site;
- Pregnancy;
- Refusal to participate in the study or inability to communicate;
- Long-term use of opioids;
- Body mass index >35 kg/m2;
- History of nerve injury, paralysis, or paresis.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
China · 1 center
- Jiaxing University Affiliated Hospital — Jiaxing
Identifiers
NCT: NCT06972680 · 2025-LP-076