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

Shanghai Jiao Tong University logo

Shanghai Jiao Tong University

Status

Invitation-only

Conditions

Diaphragm Movement

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT07382063
2025-204-(1)

Details and patient eligibility

About

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.

Enrollment

72 estimated patients

Sex

All

Ages

6 to 12 years old

Volunteers

No 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).

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

72 participants in 2 patient groups, including a placebo group

intra-fascial interscalene brachial plexus block (ISB)
Placebo Comparator group
Treatment:
Procedure: intra-fascial interscalene brachial plexus block (ISB)
extra-fascial interscalene brachial plexus block (ISB)
Experimental group
Treatment:
Procedure: extra-fascial interscalene brachial plexus block (ISB)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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