EIT Evaluation of Pulmonary Ventilation With Different Ropivacaine Concentrations in Intercostal Nerve Blockade
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 0.25% ropivacaine, 0.375% Ropivacaine, 0.5% Ropivacaine.
- Who it may be relevant to
- Registry conditions: Intercostal Nerve Block, Pulmonary Ventilation, Anesthesia, Local, Breast Neoplasms. Basic parameters: 18 years — 80 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Electrical Impedance Tomography (EIT) to Evaluate the Effect of Different Concentrations of Ropivacaine on Pulmonary Ventilation Function During Intercostal Nerve Blockade
Overview
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.
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.
Interventions
- Drug 0.25% ropivacaine
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 0.375% Ropivacaine
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, th - Drug 0.5% Ropivacaine
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
Primary outcome measures
- The percentage decrease (/L) of the surgical side lung ventilation to total lung ventilation after blockade [Time frame: 15 minutes after blockade]
Secondary outcome measures (1)
- Block success rate [Time frame: 5 minutes after surgery]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07079436 · XTJLBTNDLPKA-1