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

NCT06011044 | Unknown

• 1 other identifier: Bwen
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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

Conditions

Intercostal Nerve Block

Outcome Measures

Primary Outcomes (1)

• The Visual Analogue Scale (VAS)

  We will use VAS score to assess the analgesic effects . The Visual Analogue Scale (VAS) has been in use for the measurement of intangible quantities such as pain since the 1920s. It consists of a line usually 100mm in length, with anchor descriptors such as "no pain" and "worst pain imaginable", The patient makes a mark reflecting his or her perception, and the distance from the left endpoint to the mark is measured, in mm.

  first month after surgery

Secondary Outcomes (1)

• The Visual Analogue Scale (VAS)

  third month after surgery

Study Arms (2)

Intercostal nerve block with ropivacaine（0.5%）

EXPERIMENTAL

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.

Procedure: Intercostal Nerve Block

no intercostal nerve block.

NO INTERVENTION

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.

Interventions

Intercostal Nerve Block 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.

Intercostal nerve block with ropivacaine（0.5%）

Eligibility Criteria

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

You may qualify if:

• Patients undergoing surgery for small pulmonary nodules in the Department of Thoracic Surgery, China-Japan Friendship Hospital in Beijing
• Age≥ 18 years old
• Lung small nodules with a diameter of ≤ 2cm, pure ground-glass/mixed/solid nodules
• Permanent residents can be followed up for a long time
• Sign informed consent.

You may not qualify if:

• Refusal to sign informed consent
• Damaged heart, lung, liver and kidney function
• 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

Sponsors & Collaborators

• Bixin Wen: lead

Central Study Contacts

QianLI MA, doctor's degree

CONTACT

86+13681332289; mars_qlma@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 22, 2023
• First Posted: August 25, 2023
• Study Start: August 19, 2023
• Primary Completion: October 19, 2023
• Study Completion: October 19, 2023
• Last Updated: August 25, 2023

Record last verified: 2023-08