Electrical impedance tomography (EIT) to evaluate the effect of different concentrations of ropivacaine on pulmonary ventilation function during intercostal nerve blockade
NCT ID NCT07079436
First seen Sep 10, 2026 · Last updated Sep 10, 2026
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. 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. 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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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67 people
The number who actually took part.
- Started
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Jul 2025
- Finished
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Jul 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Fudan university shanghai cancer center
Shanghai, 200120, China
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