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

NCT06972680 | Enrolling By Invitation DMC

• 1 other identifier: 2025-LP-076
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Shoulder Arthroscopy

Keywords

Interscalene brachial plexus block; Phrenic nerve block

Outcome Measures

Primary Outcomes (2)

• Hemidiaphragmatic paresis incidence rate(Phase Ⅰ)

  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.

  Perioperative

• Success rate of interscalene brachial plexus block (Phase II)

  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.

  Perioperative

Secondary Outcomes (2)

• Hemidiaphragmatic paresis incidence rate

  Perioperative

• Lung function

  Perioperative

Study Arms (1)

Interscalene brachial plexus block

Drug: Bupivacaine Liposomes(BL)

Interventions

Bupivacaine Liposomes(BL) 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.

Interscalene brachial plexus block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients scheduled for elective arthroscopic shoulder surgery at Jiaxing University Affiliated Hospital.

You may qualify if:

• Patients aged 18 years and above;
• ASA classification I-III;
• Undergoing arthroscopic rotator cuff repair, capsular tightening, acromioplasty, synovectomy,.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Affiliated Hospital of Jiaxing University: lead

Study Sites (1)

Jiaxing University Affiliated Hospital

Jiaxing, Zhejiang, 314000, China

Location

Study Officials

• Mingzi An, MD

  Jiaxing University Affiliated Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Affiliated Hospital of Jiaxing University

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: May 15, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: May 15, 2025

Record last verified: 2025-05

Locations

CN (1)