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

NCT07079436 | Not Yet Recruiting

• 1 other identifier: XTJLBTNDLPKA-1
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Intercostal Nerve Block; Pulmonary Ventilation; Anesthesia, Local; Breast Neoplasms; Surgical Procedures, Operative

Keywords

Ropivacaine; Intercostal Nerve Block; Pulmonary Ventilation Function; Electrical Impedance Tomography; Anesthetic Concentration; Breast Neoplasms

Outcome Measures

Primary Outcomes (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".

  15 minutes after blockade

Secondary Outcomes (1)

• Block success rate

  5 minutes after surgery

Other Outcomes (3)

• Adverse events

  1 hour after surgery

• Pain-related assessment

  24 hours after surgery

• Pain-related assessment

  6 hours after surgery

Study Arms (3)

Arm A: 0.25% Ropivacaine for Intercostal Nerve Blockade

EXPERIMENTAL

The 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.

Drug: 0.25% ropivacaine

Arm B: 0.375% Ropivacaine for Intercostal Nerve Blockade

EXPERIMENTAL

The 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.

Drug: 0.375% Ropivacaine

Arm C: 0.5% Ropivacaine for Intercostal Nerve Blockade

EXPERIMENTAL

The 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.

Drug: 0.5% Ropivacaine

Interventions

0.25% ropivacaine DRUG

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.

Also known as: Ropivacaine Hydrochloride Injection , Naropin , AstraZeneca AB, Sweden

Arm A: 0.25% Ropivacaine for Intercostal Nerve Blockade

0.375% Ropivacaine DRUG

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.

Also known as: Ropivacaine Hydrochloride Injection , Naropin , AstraZeneca AB, Sweden

Arm B: 0.375% Ropivacaine for Intercostal Nerve Blockade

0.5% Ropivacaine DRUG

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.

Also known as: Ropivacaine Hydrochloride Injection , Naropin , AstraZeneca AB, Sweden

Arm C: 0.5% Ropivacaine for Intercostal Nerve Blockade

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fudan University: lead

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doc.

Study Record Dates

• First Submitted: June 3, 2025
• First Posted: July 23, 2025
• Study Start: August 10, 2025
• Primary Completion: December 30, 2025
• Study Completion: December 31, 2025
• Last Updated: July 23, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share