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Enrolling by invitation Not applicable

Effect of Liposomal Bupivacaine and Bupivacaine Hydrochloride for Superior Trunk Block of the Interscalene Brachial Plexus on Postoperative Diaphragmatic Function and Analgesia

NCT07587203 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2026-06-01
Last updated
2026-06-16

Condition(s) studied

Proximal Humerus SurgeryRotator Cuff SurgeryShoulder ArthroplastyShoulder Arthroscopy

Investigational drug(s) / intervention(s)

Liposomal bupivacaine →Bupivacaine Hydrochloride →

Liposomal bupivacaine: The superior trunk was visualized distal to the convergence of the C5 and C6 nerve roots but proximal to the take-off of the suprascapular nerve. The block needle was advanced in-plane to the ultrasound beam in a lateral-to-medial direction under the deep cervical fascia and superficial to the middle scalene muscle, until the needle tip was immediately adjacent to the lateral border of the superior trunk. 1.33% Liposomal bupivacaine 10ml was injected.

Bupivacaine Hydrochloride: The superior trunk was visualized distal to the convergence of the C5 and C6 nerve roots but proximal to the take-off of the suprascapular nerve. The block needle was advanced in-plane to the ultrasound beam in a lateral-to-medial direction under the deep cervical fascia and superficial to the middle scalene muscle, until the needle tip was immediately adjacent to the lateral border of the superior trunk. 0.375% Bupivacaine Hydrochloride 10ml was injected.

Study summary

To compare the effects of 1.33% liposomal bupivacaine versus 0.375% bupivacaine hydrochloride for superior trunk block of the interscalene brachial plexus on postoperative diaphragmatic function and analgesic efficacy in shoulder surgery.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: * Patients scheduled for elective unilateral proximal humerus surgery, rotator cuff surgery, shoulder arthroplasty, or shoulder arthroscopy; * Visible diaphragmatic movement on the surgical side under ultrasound before anesthesia; * Patient provides informed consent; * Age 18-80 years, any gender; * ASA physical status I-III; * 18 kg/m² ≤ BMI ≤ 30 kg/m². Exclusion Criteria: * Coagulopathy; * Allergy to local anesthetics; * Infection at the puncture site; * History of chronic pain or opioid use; * Severe respiratory disease; * Pregnancy; * Diabetes and peripheral neuropathy; * Inability to understand assessment scales.

Primary outcome measure(s)

  • The incidence of hemi-diaphragmatic paralysis( Partial plus complete diaphragmatic paralysis) after superior trunk block of the interscalene brachial plexus — Before block and before leaving the PACU after surgery
    Observe diaphragmatic movement through the hepatic or splenic acoustic window and measure the amplitude of diaphragmatic excursion on the anesthetized side using M-mode (average of 3 waveforms). Diaphragmatic Function Evaluation\[4,5\]: A decrease in diaphragmatic excursion amplitude during deep breathing of \<25% compared to pre-block is defined as normal diaphragmatic movement. A decrease of 25%-75% is defined as partial diaphragmatic paralysis. A decrease of \>75% is defined as complete diaphragmatic paralysis.

Trial sites (3)

FacilityCityRegionStatus
Nanjing First Hospital Nanjing Jiangsu
Nanjing Gaochun People's Hospital Nanjing Jiangsu
The First Affiliated Hospital of Soochow University Suzhou Jiangsu
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07587203 on ClinicalTrials.gov ↗ ← All trials in China