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

NCT07382063 | Enrolling By Invitation DMC

• 1 other identifier: 2025-204-(1)
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Diaphragm Movement

Outcome Measures

Primary Outcomes (1)

• To evaluate the rate of diaphragmatic paralysis using ultrasound.

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

Study Arms (2)

intra-fascial interscalene brachial plexus block (ISB)

PLACEBO COMPARATOR

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

extra-fascial interscalene brachial plexus block (ISB)

EXPERIMENTAL

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

Interventions

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.

intra-fascial interscalene brachial plexus block (ISB)

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.

extra-fascial interscalene brachial plexus block (ISB)

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age range: School-aged children (6-12 years old).
• Type of surgery: Upper limb surgery.
• ASA classification: Grades I-II.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Shanghai Jiao Tong University Affiliated Sixth People's Hospital: lead

Study Sites (1)

Shanghai Sixth People's Hospital

Shanghai, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: anesthesiologist

Study Record Dates

• First Submitted: January 26, 2026
• First Posted: February 2, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: February 3, 2026

Record last verified: 2026-01

Locations

CN (1)