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

NCT ID: NCT06972680

Last Updated: 2025-05-15

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-05-01
• Study Completion Date: 2027-12-30

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 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.

Conditions

Shoulder Arthroscopy

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Interscalene brachial plexus block

Bupivacaine Liposomes(BL)

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Affiliated Hospital of Jiaxing University

OTHER

Sponsor Role: lead

Responsible Party

Qing-he Zhou

Affiliated Hospital of Jiaxing University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mingzi An, MD

Role: PRINCIPAL_INVESTIGATOR

Jiaxing University Affiliated Hospital

Locations

Jiaxing University Affiliated Hospital

Jiaxing, Zhejiang, China

Countries

China

Other Identifiers

2025-LP-076

Identifier Type: -

Identifier Source: org_study_id