Clinical Trials in China / NCT06972680
Enrolling by invitation
Observational
Determination of the Optimal Volume of 0.5% Bupivacaine Liposome in Single-Injection Interscalene Brachial Plexus Block: A Bayesian Phase I/II Trial
NCT06972680 · tracked via the Priya Life Science China tracker
Condition(s) studied
Shoulder Arthroscopy
Investigational drug(s) / intervention(s)
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.
Study summary
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.
Eligibility
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.
Primary outcome measure(s)
- Hemidiaphragmatic paresis incidence rate(Phase Ⅰ) — Perioperative
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. - Success rate of interscalene brachial plexus block (Phase II) — Perioperative
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.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Jiaxing University Affiliated Hospital | Jiaxing | Zhejiang |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06972680 on ClinicalTrials.gov ↗ ← All trials in China