Effects of Extra-fascial Interscalene Brachial Plexus Block on Diaphragmatic Function in School-Aged Children
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: extra-fascial interscalene brachial plexus block (ISB), intra-fascial interscalene brachial plexus block (ISB).
- Who it may be relevant to
- Registry conditions: Diaphragm Movement. Basic parameters: 6 years — 12 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Procedure 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. - Procedure 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.
Primary outcome measures
- To evaluate the rate of diaphragmatic paralysis using ultrasound. [Time frame: From enrollment to the end of treatment at 2-3 days]
Eligibility criteria
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Prevention
Study locations
China · 1 center
- Shanghai Sixth People's Hospital — Shanghai
Identifiers
NCT: NCT07382063 · 2025-204-(1)