Diaphragm MovementNCT07382063
Effects of Extra-fascial Interscalene Brachial Plexus Block on Diaphragmatic Function in School-Aged Children
A study testing extra-fascial interscalene brachial plexus block (ISB) and intra-fascial interscalene brachial plexus block (ISB) in people with Diaphragm Movement, run by Shanghai Jiao Tong University Affiliated Sixth People's Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Diaphragm Movement
- What is being tested?
- extra-fascial interscalene brachial plexus block (ISB) and intra-fascial interscalene brachial plexus block (ISB)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2026to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age range: School-aged children (6-12 years old).
- Type of surgery: Upper limb surgery.
- ASA classification: Grades I-II.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
- Being tested
- extra-fascial interscalene brachial plexus block (ISB), intra-fascial interscalene brachial plexus block (ISB)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
extra-fascial interscalene brachial plexus block (ISB)Procedure or surgery
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 or surgery
Perform an intra-fascial interscalene brachial plexus block by penetrating the brachial plexus fascia and injecting 0.5 ml/kg of 0.2% ropivacaine.
| Study group | Role | What they receive |
|---|---|---|
| intra-fascial interscalene brachial plexus block (ISB) | Placebo comparator | Not described Receives: Procedure: intra-fascial interscalene brachial plexus block (ISB) |
| extra-fascial interscalene brachial plexus block (ISB) | Experimental | Not described Receives: Procedure: extra-fascial interscalene brachial plexus block (ISB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the rate of diaphragmatic paralysis using ultrasound.
Measured: From enrollment to the end of treatment at 2-3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start1 Feb 2026 (estimated)
- Primary completion31 Oct 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diaphragm MovementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University Affiliated Sixth People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiaqi Shan, Shanghai Jiao Tong University Affiliated Sixth People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07382063
- Sponsor's protocol ID
- 2025-204-(1)
- Status last verified
- Jan 2026
- First submitted
- 26 Jan 2026
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Extra-fascial Interscalene Brachial Plexus Block on Diaphragmatic Function in School-Aged Children
- ClinicalTrials.gov ID
- NCT07382063
- Acronym / sponsor ID
- 2025-204-(1)
- Conditions
- Diaphragm Movement
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University Affiliated Sixth People's HospitalUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 2 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age range: School-aged children (6-12 years old).
- Type of surgery: Upper limb surgery.
- ASA classification: Grades I-II.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | extra-fascial interscalene brachial plexus block (ISB) |
| 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. | Procedure or surgery | intra-fascial interscalene brachial plexus block (ISB) |
Primary outcome
To evaluate the rate of diaphragmatic paralysis using ultrasound.
Time frame: From enrollment to the end of treatment at 2-3 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing extra-fascial interscalene brachial plexus block (ISB) and intra-fascial interscalene brachial plexus block (ISB) in people with Diaphragm Movement, run by Shanghai Jiao Tong University Affiliated Sixth People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the rate of diaphragmatic paralysis using ultrasound. (time frame: From enrollment to the end of treatment at 2-3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2026.