Effects of Extra-fascial Interscalene Brachial Plexus Block on Diaphragmatic Function in School-A… (NCT07382063) | Clinical Trial Compass
By InvitationNot Applicable
Effects of Extra-fascial Interscalene Brachial Plexus Block on Diaphragmatic Function in School-Aged Children
China72 participantsStarted 2026-02-01
Plain-language 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.
Who can participate
Age range
6 Years – 12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To evaluate the rate of diaphragmatic paralysis using ultrasound.
Timeframe: From enrollment to the end of treatment at 2-3 days
Trial details
NCT IDNCT07382063
SponsorShanghai Jiao Tong University Affiliated Sixth People's Hospital