By InvitationNot Applicable

Determination of the Optimal Volume of 0.5% Bupivacaine Liposome in Single-Injection Interscalene Brachial Plexus Block: A Bayesian Phase I/II Trial

China60 participantsStarted 2025-05-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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.

What they're measuring

Hemidiaphragmatic paresis incidence rate(Phase Ⅰ)

Timeframe: Perioperative

Success rate of interscalene brachial plexus block (Phase II)

Timeframe: Perioperative

Trial details

NCT IDNCT06972680

SponsorAffiliated Hospital of Jiaxing University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-12-30

View on ClinicalTrials.gov More Shoulder Arthroscopy trials