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Enrolling by Invitation

NCT Number: NCT07382063

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

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.

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Key information

Conditions

Diaphragm Movement

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Sixth People's Hospital

Shanghai, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

extra-fascial interscalene brachial plexus block (ISB)

Procedure

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)

Procedure

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 outcomes

  1. To evaluate the rate of diaphragmatic paralysis using ultrasound.

    Time frame: From enrollment to the end of treatment at 2-3 days

Sponsors and collaborators

Lead sponsor

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 2, 2026
Registry last updated
Feb 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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