Status:
ENROLLING_BY_INVITATION
Determination of the Optimal Volume of 0.5% Bupivacaine Liposome in Single-Injection Interscalene Brachial Plexus Block: A Bayesian Phase I/II Trial
Lead Sponsor:
Affiliated Hospital of Jiaxing University
Conditions:
Shoulder Arthroscopy
Eligibility:
All Genders
18+ years
Brief 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 injec...
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 ...
Eligibility Criteria
Inclusion
- Patients aged 18 years and above;
- ASA classification I-III;
- Undergoing arthroscopic rotator cuff repair, capsular tightening, acromioplasty, synovectomy,.
Exclusion
- 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.
Key Trial Info
Start Date :
May 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 30 2027
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06972680
Start Date
May 1 2025
End Date
December 30 2027
Last Update
May 15 2025
Active Locations (1)
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1
Jiaxing University Affiliated Hospital
Jiaxing, Zhejiang, China, 314000