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

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

Status
Enrolling by invitation
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07382063
Enrollment
72
Registered
2026-02-02
Start date
2026-02-01
Completion date
2026-11-30
Last updated
2026-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diaphragm Movement

Brief 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.

Interventions

PROCEDUREextra-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.

PROCEDUREintra-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.

Sponsors

Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
No

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).

Design outcomes

Primary

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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026