Effects of Extra-fascial Interscalene Brachial Plexus Block on Diaphragmatic Function in School-Aged Children

NCT07382063 · tracked via the Priya Life Science China tracker

Sponsor

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Phase

Not applicable

Started

2026-02-01

Last updated

2026-02-03

Condition(s) studied

Diaphragm Movement

Investigational drug(s) / intervention(s)

extra-fascial interscalene brachial plexus block (ISB)intra-fascial interscalene brachial plexus block (ISB)

extra-fascial interscalene brachial plexus block (ISB): Perform an extra-fascial interscalene brachial plexus block, positioning the needle tip 2-4 mm lateral to the brachial plexus sheath, at a level equidistant between the C5 and C6 roots, measured using the on-screen caliper tool. Inject 0.5 ml/kg of 0.2% ropivacaine for nerve blockade.

intra-fascial interscalene brachial plexus block (ISB): Perform an intra-fascial interscalene brachial plexus block by penetrating the brachial plexus fascia and injecting 0.5 ml/kg of 0.2% ropivacaine.

Study summary

The traditional intra-fascial interscalene brachial plexus block (ISB) is already one of the routine anesthesia methods for pediatric upper limb surgeries in clinical practice. This study aims to clarify the effect of the extra-fascial interscalene brachial plexus block on the diaphragm function of school-age children, as well as its analgesic effect, and to compare it with the traditional intra-fascial ISB. It intends to explore a more effective and safer ISB method for children. With the aim of optimizing techniques and accurately evaluating, to balance the benefits of analgesia and safety, and thereby promoting the development of precise pediatric anesthesia.

Eligibility

Sex

ALL

Min age

6 Years

Max age

12 Years

Healthy volunteers

Inclusion Criteria: * Age range: School-aged children (6-12 years old). * Type of surgery: Upper limb surgery. * ASA classification: Grades I-II. Exclusion Criteria: * Infection, anatomical deformity, or tumor at the puncture site. * Coagulation disorders (INR \> 1.4, platelet count \< 100 × 10⁹/L). * History of allergy to local anesthetics (ropivacaine). * Severe cardiopulmonary or neurological diseases (e.g., epilepsy, myopathy). * Pre-existing ipsilateral phrenic nerve paralysis or Horner syndrome. * Preoperative long-term use of analgesics (which may affect efficacy assessment). * Parent or child refusal to participate in the study. * Emergency surgery or inability to cooperate with assessments (e.g., severe developmental delay).

Primary outcome measure(s)

To evaluate the rate of diaphragmatic paralysis using ultrasound. — From enrollment to the end of treatment at 2-3 days

Trial sites (1)

Facility	City	Region	Status
Shanghai Sixth People's Hospital	Shanghai	China

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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 NCT07382063 on ClinicalTrials.gov ↗ ← All trials in China