Intercostal Nerve BlockNCT06011044
Intercostal Nerve Block With Local Anesthesia Administered Via Incision-specific Multi-site Injection for Thoracic Surgery
A study testing Intercostal Nerve Block in people with Intercostal Nerve Block, run by Bixin Wen.
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intercostal Nerve Block
- What is being tested?
- Intercostal Nerve Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 19 Aug 2023to 19 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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
Read the 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
- Being tested
- Intercostal Nerve Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intercostal Nerve BlockProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: first month after surgery
Secondary 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.
Measured: third month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2023
- Study start19 Aug 2023 (estimated)
- Primary completion19 Oct 2023 (estimated)
- Study completion19 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intercostal Nerve BlockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bixin Wen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bixin Wen, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06011044
- Sponsor's protocol ID
- Bwen
- Status last verified
- Aug 2023
- First submitted
- 22 Jun 2023
- Last updated
- 25 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intercostal Nerve Block With Local Anesthesia Administered Via Incision-specific Multi-site Injection for Thoracic Surgery
- ClinicalTrials.gov ID
- NCT06011044
- Acronym / sponsor ID
- Bwen
- Conditions
- Intercostal Nerve Block
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Bixin WenUniversity, hospital or other
- Study start
- 19 Aug 2023 (estimated)
- Primary completion
- 19 Oct 2023 (estimated)
- Study completion
- 19 Oct 2023 (estimated)
- First posted
- 25 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intercostal nerve block with ropivacaine（0.5%） | Experimental | Procedure: Intercostal Nerve BlockThis 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intercostal Nerve BlockThe 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. | Procedure or surgery | Intercostal nerve block with ropivacaine（0.5%） |
Primary outcome
The Visual Analogue Scale (VAS)
Time frame: first month after surgery
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.
1 secondary outcome
The Visual Analogue Scale (VAS)
Time frame: third month after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Intercostal Nerve Block in people with Intercostal Nerve Block, run by Bixin Wen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact QianLI MA, doctor's degree (86+13681332289, mars_qlma@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Visual Analogue Scale (VAS) (time frame: first month after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2023.