Intercostal Nerve Block With Local Anesthesia Administered Via Incision-specific Multi-site Injection for Thoracic Surgery

NCT ID: NCT06011044

Last Updated: 2023-08-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-19
• Study Completion Date: 2023-10-19

Brief Summary

The goal of this clinical trial is to test analgesic effect of intercostal nerve block in different range. The main question it aims to answer are:

question 1: whther incision-specific multi-site injection (ISMSI, from the 3rd to 8th intercostal nerve) can improve the analgesic benefits .

The participants will be divided into three groups to compare the analgesic effects of different intercostal nerve blocks

Detailed Description

Postoperative pain after thoracic surgery is usually severe, and potentially leads to worse outcomes. It is well known that the use of intercostal nerve block (ICNB) analgesia with local anesthesia is common in thoracic surgery. Compared with the traditional standard of epidural analgesia, it has the advantages of less effect on respiratory or circulation system and less postoperative complications such as hypotension and hematoma. However, the details of ICNB form different hospital are in different ways. And it is unclear how many intercostal nerves should be blocked. And it is unknown which area should be payed more attention either, like the incision area or the chest tube port. It is hypothesized that the incision-specific multi-site injection (ISMSI, from the 3rd to 8th intercostal nerve) can improve the analgesic benefits due to cover area of both incision and chest tube port. To test this hypothesis, the investigators did this study to evaluate the analgesic effect of different ICNB methods.

The participants will be divided into three groups. A(incision-specific multi-site injection, received intraoperative 3-8 intercostal nerve block ) B(single injection, received intraoperative 3-5 intercostal nerve block ) and C(received no intercostal nerve block). Then compare the analgesic effects of the three groups.

Conditions

Intercostal Nerve Block

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intercostal nerve block with ropivacaine（0.5%）

This group of patients will be further divided into 2 groups. Group A (incision-specific multi-site injection) received intraoperative 3-8 intercostal nerve block with 0.5% ropivacaine. Group B (single injection) received intraoperative 3-5 intercostal nerve block with 0.5% .After completing lung surgery, fully exposing the lateral and posterior chest wall. From the inside view of the chest cavity, the intercostal nerve enters the correlated intercostal space between the posterior intercostal membrane and the parietal pleura. The needle of the 1ml syringe was held with a thoracoscopic ovale forceps and the target intercostal nerves were confirmed. It is only necessary to puncture the parietal pleura at the side of the intercostal nerve to perform the block. Inject ropivacaine(1ml, 0.5%) into the target nerve. At the same time, we recorded patients' mental status and vital signs to avoid systemic toxicity.

Group Type: EXPERIMENTAL

Intercostal Nerve Block

Intervention Type: PROCEDURE

The intercostal nerve block test is a medical intervention that involves the administration of a local anesthetic to the intercostal nerves, which are located between the ribs. The intervention involves injecting a small amount of anesthetic solution near the targeted intercostal nerves, which temporarily numbs the area and provides potential pain relief. The intercostal nerve block test is considered a diagnostic tool to help guide further treatment decisions for conditions such as intercostal neuralgia, rib fractures, or postoperative pain. It is generally a safe and well-tolerated procedure, often performed under local anesthesia or with the assistance of image guidance to ensure accurate needle placement. Following the test, the patient's response is evaluated, and if pain relief is achieved, it may indicate that intercostal nerve block injections could be an appropriate treatment option.

no intercostal nerve block.

This group of patients will not receive intraoperative intercostal nerve block with 0.5% ropivacaine. After completing lung surgery, fully exposing the lateral and posterior chest wall. From the inside view of the chest cavity, the intercostal nerve enters the correlated intercostal space between the posterior intercostal membrane and the parietal pleura. The needle of the 1ml syringe was held with a thoracoscopic ovale forceps and the target intercostal nerves were confirmed. Inject physiologic saline(1ml) into the target nerve.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Intercostal Nerve Block

The intercostal nerve block test is a medical intervention that involves the administration of a local anesthetic to the intercostal nerves, which are located between the ribs. The intervention involves injecting a small amount of anesthetic solution near the targeted intercostal nerves, which temporarily numbs the area and provides potential pain relief. The intercostal nerve block test is considered a diagnostic tool to help guide further treatment decisions for conditions such as intercostal neuralgia, rib fractures, or postoperative pain. It is generally a safe and well-tolerated procedure, often performed under local anesthesia or with the assistance of image guidance to ensure accurate needle placement. Following the test, the patient's response is evaluated, and if pain relief is achieved, it may indicate that intercostal nerve block injections could be an appropriate treatment option.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Patients undergoing surgery for small pulmonary nodules in the Department of Thoracic Surgery, China-Japan Friendship Hospital in Beijing

2. Age≥ 18 years old

3. Lung small nodules with a diameter of ≤ 2cm, pure ground-glass/mixed/solid nodules

4. Permanent residents can be followed up for a long time

5. Sign informed consent.

Exclusion Criteria

1. Refusal to sign informed consent

2. Damaged heart, lung, liver and kidney function

3. Contraindications to surgery, such as inability to tolerate anesthesia, distant metastasis, bleeding tendency, etc c(4) Combined with severe emphysema, tuberculosis, pneumothorax, pleural effusion (5) Patients have other conditions that are not suitable for interventional surgery, such as pregnancy, lactation, long-term use of immunosuppressants, and serious infections

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bixin Wen

OTHER

Sponsor Role: lead

Responsible Party

Bixin Wen

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

QianLI MA, doctor's degree

Role: CONTACT

mars_qlma@163.com

86+13681332289

Other Identifiers

Bwen

Identifier Type: -

Identifier Source: org_study_id