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Intercostal Nerve BlockEITNCT07079436

EIT Evaluation of Pulmonary Ventilation With Different Ropivacaine Concentrations in Intercostal Nerve Blockade

A study testing 0.25% ropivacaine, 0.375% Ropivacaine and 0.5% Ropivacaine in people with Intercostal Nerve Block and Pulmonary Ventilation, run by Fudan University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study aims to find out how different strengths of the anesthetic drug ropivacaine affect lung breathing function when used in intercostal nerve block (a type of local anesthesia) for breast quadrantectomy surgery. Read more about this study

Who is it for?
Ages 18 to 80 years, women only
What is being tested?
0.25% ropivacaine, 0.375% Ropivacaine and 0.5% Ropivacaine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
67 participants
Where
1 siteChina
Study dates
25 Jul 2025to 30 Jul 2026
Phase
Interventional
Are there results?
None posted in the registry

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 18 to 80 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients scheduled for elective breast quadrantectomy;
  • Aged 18-80 years;
  • American Society of Anesthesiologists (ASA) physical status I-II;
  • Body mass index (BMI) <35 kg/m².

Who cannot join

  • Contraindications for nerve block: infection at the puncture site, local anesthetic allergy, coagulation dysfunction or bleeding risk;
  • Patients with unilateral diaphragmatic paralysis;
  • Patients with severe ventilatory or gas exchange dysfunction;
  • Complicated with acute or chronic pulmonary and bronchial diseases, sleep apnea syndrome;
  • Mental disorders;
  • Patients who refuse to participate;
  • Patients whom the researchers consider unsuitable for the clinical trial, with reasons to be specified.

Trial locations and contacts

1 site in 1 country.

China1 site
  • Fudan university shanghai cancer center

    Shanghai, 200120

Other trials in China

About this study

Official title: Electrical Impedance Tomography (EIT) to Evaluate the Effect of Different Concentrations of Ropivacaine on Pulmonary Ventilation Function During Intercostal Nerve Blockade

This study aims to find out how different strengths of the anesthetic drug ropivacaine affect lung breathing function when used in intercostal nerve block (a type of local anesthesia) for breast quadrantectomy surgery. Researchers will use a non-invasive imaging technique called electrical impedance tomography (EIT) to monitor lung ventilation in real time.

Why is this study being done? Intercostal nerve block is a common anesthesia method for breast surgeries, but the ideal strength of ropivacaine that balances effective pain relief with safety for lung function is not fully clear. EIT can help measure how each drug strength affects breathing by showing changes in lung airflow.

Read more

What will happen in the study? Participants: 72 adults scheduled for breast quadrantectomy, aged 18-80, will be randomly assigned to receive one of three ropivacaine strengths (0.25%, 0.375%, or 0.5%) during intercostal nerve block.

Procedures: After anesthesia, EIT will monitor lung ventilation before and after the block. Researchers will measure:

How much each lung side contributes to breathing during quiet and deep breaths. How quickly the anesthesia works, pain levels during surgery, and any side effects (like difficulty breathing or allergic reactions).

Who can join? Adults having elective breast quadrantectomy. ASA physical status I-II (generally healthy to mildly ill). BMI <35 kg/m². No history of nerve block allergies, breathing problems, or certain lung diseases.

What are the possible benefits? The study may help doctors choose the best ropivacaine strength to ensure good pain control while minimizing risks to lung function, especially for same-day surgery patients.

What are the risks? Potential risks include rare side effects from the anesthetic (like allergic reactions or low blood pressure) or temporary breathing changes, which will be closely monitored.

How is the study designed? This is a double-blind, randomized trial (neither patients nor doctors know which drug strength is used) at Fudan University Shanghai Cancer Center.

Read the detailed description

The purpose of this study is to explore the impact of different concentrations of ropivacaine on pulmonary ventilation function and anesthetic efficacy during intercostal nerve block, so as to provide a reference for clinical medication selection.

This is a single-center, prospective, randomized controlled trial, with the research subjects being patients scheduled to undergo breast quadrant resection under intercostal nerve block anesthesia. Eligible patients will be randomly assigned to three groups, receiving 0.25%, 0.375%, or 0.5% ropivacaine for intercostal nerve block respectively (4ml injected into each intercostal space, blocking the 2nd to 6th intercostal nerves). The procedure will be performed by experienced anesthesiologists under ultrasound guidance, with a double-blind design where neither the anesthesiologists nor the patients are aware of the grouping and drug concentration information.

In the study, Electrical Impedance Tomography (EIT) will be used for real-time, non-invasive monitoring of changes in patients' pulmonary ventilation function before and after the block. Meanwhile, indicators related to anesthetic efficacy such as the onset time of anesthesia and block success rate will be evaluated. The entire research process includes preoperative screening, intraoperative intervention, and postoperative follow-up, aiming to clarify the relationship between ropivacaine concentration, its impact on pulmonary ventilation function, and anesthetic efficacy, so as to provide a basis for optimizing the clinical application of ropivacaine in intercostal nerve block.

Being tested
0.25% ropivacaine, 0.375% Ropivacaine, 0.5% Ropivacaine
Keywords
Ropivacaine, Intercostal Nerve Block, Pulmonary Ventilation Function, Electrical Impedance Tomography, Anesthetic Concentration, Breast Neoplasms
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 0.25% ropivacaineDrug

    Also called Ropivacaine Hydrochloride Injection , Naropin , AstraZeneca AB, Sweden

    During breast quadrantectomy, intercostal nerve block is performed at the 2nd to 6th intercostal spaces along the posterior axillary line using an in-plane technique. 4ml of 0.25% ropivacaine (prepared from Naropin, 10ml:75mg) is injected into each intercostal space. Under ultrasound guidance, the needle tip is ensured to reach the space between the internal intercostal muscle (intercostal endomysium) and the innermost intercostal muscle below the rib margin. After aspiration shows no blood, the drug is injected, and anechoic fluid can be seen diffusing below the internal intercostal muscle, with the local parietal pleura gradually descending as the injected fluid volume increases.

  • 0.375% RopivacaineDrug

    Also called Ropivacaine Hydrochloride Injection , Naropin , AstraZeneca AB, Sweden

    During breast quadrantectomy, intercostal nerve block is performed at the 2nd to 6th intercostal spaces along the posterior axillary line using an in-plane technique. 4ml of 0.375% ropivacaine (prepared from Naropin, 10ml:75mg) is injected into each intercostal space. Under ultrasound guidance, the needle tip is ensured to reach the space between the internal intercostal muscle (intercostal endomysium) and the innermost intercostal muscle below the rib margin. After aspiration shows no blood, the drug is injected, and anechoic fluid can be seen diffusing below the internal intercostal muscle, with the local parietal pleura gradually descending as the injected fluid volume increases.

  • 0.5% RopivacaineDrug

    Also called Ropivacaine Hydrochloride Injection , Naropin , AstraZeneca AB, Sweden

    During breast quadrantectomy, intercostal nerve block is performed at the 2nd to 6th intercostal spaces along the posterior axillary line using an in-plane technique. 4ml of 0.5% ropivacaine (prepared from Naropin, 10ml:75mg) is injected into each intercostal space. Under ultrasound guidance, the needle tip is ensured to reach the space between the internal intercostal muscle (intercostal endomysium) and the innermost intercostal muscle below the rib margin. After aspiration shows no blood, the drug is injected, and anechoic fluid can be seen diffusing below the internal intercostal muscle, with the local parietal pleura gradually descending as the injected fluid volume increases.

Study groups in NCT07079436
Study groupRoleWhat they receive
Arm A: 0.25% Ropivacaine for Intercostal Nerve BlockadeExperimentalThe in-plane technique was adopted, with the needle inserted 5 mm away from the long axis of the probe. During the operation, the long axis of the needle and the needle tip were displayed in real time. When the needle tip reached the extrapleural space, between the internal intercostal muscle (internal intercostal membrane) and the innermost intercostal muscle at the lower edge of the rib, and no blood was aspirated, ropivacaine (Naropin 10ml:75mg) of corresponding concentration and volume was injected into each group. Anechoic fluid was observed to spread under the internal intercostal muscle, and as the volume of the injected fluid increased, the local parietal pleura gradually descended. Inject 4 ml of 0.25% ropivacaine into each intercostal space.
Receives: Drug: 0.25% ropivacaine
Arm B: 0.375% Ropivacaine for Intercostal Nerve BlockadeExperimentalThe in-plane technique was adopted, with the needle inserted 5 mm away from the long axis of the probe. During the operation, the long axis of the needle and the needle tip were displayed in real time. When the needle tip reached the extrapleural space, between the internal intercostal muscle (internal intercostal membrane) and the innermost intercostal muscle at the lower edge of the rib, and no blood was aspirated, ropivacaine (Naropin 10ml:75mg) of corresponding concentration and volume was injected into each group. Anechoic fluid was observed to spread under the internal intercostal muscle, and as the volume of the injected fluid increased, the local parietal pleura gradually descended. Inject 4 ml of 0.375% ropivacaine into each intercostal space.
Receives: Drug: 0.375% Ropivacaine
Arm C: 0.5% Ropivacaine for Intercostal Nerve BlockadeExperimentalThe in-plane technique was adopted, with the needle inserted 5 mm away from the long axis of the probe. During the operation, the long axis of the needle and the needle tip were displayed in real time. When the needle tip reached the extrapleural space, between the internal intercostal muscle (internal intercostal membrane) and the innermost intercostal muscle at the lower edge of the rib, and no blood was aspirated, ropivacaine (Naropin 10ml:75mg) of corresponding concentration and volume was injected into each group. Anechoic fluid was observed to spread under the internal intercostal muscle, and as the volume of the injected fluid increased, the local parietal pleura gradually descended. Inject 4 ml of 0.5% ropivacaine into each intercostal space.
Receives: Drug: 0.5% Ropivacaine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The percentage decrease (/L) of the surgical side lung ventilation to total lung ventilation after blockade

    The patient was placed in a supine position, and an EIT electrode strip was placed along the 4th intercostal space on the chest. Continuous monitoring of EIT (Drager Infinity C500, Germany) was performed, and tidal resistance changes during quiet breathing and deep breathing over at least 5 consecutive respiratory cycles were collected to construct lung ventilation distribution images. The main focus is to compare the changes in ROI% in different regions before and after the block, with comparisons made in 4 quadrants: "left upper, right upper, left lower, right lower".

    Measured: 15 minutes after blockade

Secondary outcomes (1)
  1. Block success rate

    The patient was able to undergo the surgery successfully without the need for additional rescue anesthesia measures.

    Measured: 5 minutes after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jul 2025
  2. Study start25 Jul 2025
  3. Primary completion25 Jul 2026
  4. Study completion30 Jul 2026

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
67 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07079436
Sponsor's protocol ID
XTJLBTNDLPKA-1
Acronym
EIT
Status last verified
Sep 2026
First submitted
3 Jun 2025
Last updated
10 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Sharing is not permitted under local laws.

Questions about this trial

What is this clinical trial studying?

A study testing 0.25% ropivacaine, 0.375% Ropivacaine and 0.5% Ropivacaine in people with Intercostal Nerve Block and Pulmonary Ventilation, run by Fudan University 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 4 inclusion and 7 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: finished, as of the sponsor's last update on 10 Sep 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

The percentage decrease (/L) of the surgical side lung ventilation to total lung ventilation after blockade (time frame: 15 minutes after blockade). 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 10 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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