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

N/AEnrolling By InvitationNCT06972680

Affiliated Hospital of Jiaxing University60 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Shoulder Arthroscopy

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Jiaxing University Affiliated Hospital

Jiaxing, Zhejiang, China

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: Perioperative

Secondary Outcomes

Hemidiaphragmatic paresis incidence rate

The diaphragmatic excursion was measured using ultrasound 6 hours and 24 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.

Time frame: Perioperative

Lung function

Lung function parameters, including tidal volume, vital capacity, and forced vital capacity, were measured bedside using a portable respiratory function monitor at 0.5 hours, 6 hours, and 24 hours after nerve block.

Time frame: Perioperative

Data from ClinicalTrials.gov

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