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

January 31, 2026 updated by: Jiaqi Shan, Shanghai Jiao Tong University Affiliated Sixth People's Hospital
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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China
        • Shanghai sixth people's hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: intra-fascial interscalene brachial plexus block (ISB)
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.
Experimental: extra-fascial interscalene brachial plexus block (ISB)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To evaluate the rate of diaphragmatic paralysis using ultrasound.
Time Frame: From enrollment to the end of treatment at 2-3 days
From enrollment to the end of treatment at 2-3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

November 30, 2026

Study Registration Dates

First Submitted

January 26, 2026

First Submitted That Met QC Criteria

January 26, 2026

First Posted (Actual)

February 2, 2026

Study Record Updates

Last Update Posted (Actual)

February 3, 2026

Last Update Submitted That Met QC Criteria

January 31, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 2025-204-(1)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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