Lung CancerNCT05437718
Application of Ultrasound-Guided Thoracic Paravertebral Block in Pulmonary Ablation Surgery
A study testing Ropivacaine in people with Lung Cancer, run by Affiliated Hospital of Nantong University at 1 site in China.
Trial summary
Local thermal ablation therapy of tumor is a rapidly developing minimally invasive therapy for lung tumors in recent years. This study evaluated the efficacy of thoracic paravertebral block (TPVB) for anaesthesia during ablation surgery of lung tumor. Read more about this study
- Who is it for?
- Ages 30 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Ropivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2021to 1 Jun 2022
- 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 30 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients diagnosed with lung cancer by imaging examination
- Informed consent of the patient and study approval by the Medical Ethics Committee
Who cannot join
- have a history of psychiatric illness, chronic pain, regular analgesic usage
- have contraindications to performing a TPVB, such as chest wall deformity, severe coagulopathy, local infection
- have allergy to local anaesthetic drugs
Trial locations and contacts
1 site in 1 country.
About this study
Local thermal ablation therapy of tumor is a rapidly developing minimally invasive therapy for lung tumors in recent years. This study evaluated the efficacy of thoracic paravertebral block (TPVB) for anaesthesia during ablation surgery of lung tumor.
Read the detailed description
Lung cancer is a serious threat to human health and life. Local thermal ablation therapy of tumor is the focus of domestic and overseas research in the past decade.Thoracic paravertebral nerve block (TPVB) is the technique of injecting local anaesthetic in the paravertebral space to anesthetizes the spinal nerve roots and sympathetic chain，which will produces ipsilateral and somatic blockade.The present study was designed to evaluate the analgesic effect and safety of TPVB in the ablation surgery of lung tumor.
After obtaining approval from the Hospital Ethics Committee and informed written consent from the patients,30 adult patients scheduled for Local thermal ablation therapy of lung tumours were recruited. Patients were excluded if they had a history of psychiatric illness, chronic pain, regular analgesic usage or there were contraindications to performing a TPVB, such as chest wall deformity, severe coagulopathy, local infection and allergy to local anaesthetic drugs. The study lasted a total of six months.
During the preoperative visit, all patients received the explanation of overall research approach.After entering the CT fluoroscopy room, peripheral veins and routine monitoring that included electrocardiography, pulse oximetry, and noninvasive arterial blood pressure were obtained in all patients.Thoracic paravertebral block was performed 20 minutes before the Local thermal ablation therapy began.The degree of pain was assessed using VAS score; at performing TPVB，the beginning of surgery， 6 and 24 hours after ablation surgery.Dezocine will be given as remedial analgesia.Following the operation, transferred the patients to the observation area where the vital signs were monitored for 30 min.Assessing and record the degree of patients and surgeons satisfaction for anesthetic management.
- Conditions
- Lung Cancer
- Being tested
- Ropivacaine
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineOther
Thoracic paravertebral block(TPVB) is performed on the patients who undergo the thermal ablation therapy.
| Study group | Role | What they receive |
|---|---|---|
| Group NB (thoracic paravertebral block Group) | Other | Thoracic paravertebral block(TPVB) is performed 20 minutes before the ablation surgery began,30 mL of 0.375% ropivacaine was totally injected in T3-4 and T5-6 spinal segment（the block segment can be adjusted according to the tumor site) under the ultrasound guidance. Receives: Other: Ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The degree of pain that patients feel who undergo ablation surgery is assessed by the visual analog scale (VAS).
All patients are instructed on the use of the visual analog scale (VAS) for pain assessment before surgery, then anesthetist evaluate the analgesic effect of TPVB for the ablation surgery with the VAS during surgery(0="no pain"and 10=the "worst pain").
Measured: During surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2022
- Study start1 Dec 2021
- Primary completion1 May 2022
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Affiliated Hospital of Nantong UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Nantong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuan Zhou, Affiliated Hospital of Nantong University
- Investigators
- Yuan Zhou, Doctor, Study director, Affiliated Hospital of Nantong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05437718
- Sponsor's protocol ID
- 2021-K145
- Status last verified
- Jun 2022
- First submitted
- 12 Jun 2022
- Last updated
- 29 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Ultrasound-Guided Thoracic Paravertebral Block in Pulmonary Ablation Surgery
- ClinicalTrials.gov ID
- NCT05437718
- Acronym / sponsor ID
- 2021-K145
- Conditions
- Lung Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Affiliated Hospital of Nantong UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 29 Jun 2022 (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.
Local thermal ablation therapy of tumor is a rapidly developing minimally invasive therapy for lung tumors in recent years. This study evaluated the efficacy of thoracic paravertebral block (TPVB) for anaesthesia during ablation surgery of lung tumor.
Detailed description
Lung cancer is a serious threat to human health and life. Local thermal ablation therapy of tumor is the focus of domestic and overseas research in the past decade.Thoracic paravertebral nerve block (TPVB) is the technique of injecting local anaesthetic in the paravertebral space to anesthetizes the spinal nerve roots and sympathetic chain，which will produces ipsilateral and somatic blockade.The present study was designed to evaluate the analgesic effect and safety of TPVB in the ablation surgery of lung tumor.
After obtaining approval from the Hospital Ethics Committee and informed written consent from the patients,30 adult patients scheduled for Local thermal ablation therapy of lung tumours were recruited. Patients were excluded if they had a history of psychiatric illness, chronic pain, regular analgesic usage or there were contraindications to performing a TPVB, such as chest wall deformity, severe coagulopathy, local infection and allergy to local anaesthetic drugs. The study lasted a total of six months.
During the preoperative visit, all patients received the explanation of overall research approach.After entering the CT fluoroscopy room, peripheral veins and routine monitoring that included electrocardiography, pulse oximetry, and noninvasive arterial blood pressure were obtained in all patients.Thoracic paravertebral block was performed 20 minutes before the Local thermal ablation therapy began.The degree of pain was assessed using VAS score; at performing TPVB，the beginning of surgery， 6 and 24 hours after ablation surgery.Dezocine will be given as remedial analgesia.Following the operation, transferred the patients to the observation area where the vital signs were monitored for 30 min.Assessing and record the degree of patients and surgeons satisfaction for anesthetic management.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group NB (thoracic paravertebral block Group) | Other | Other: RopivacaineThoracic paravertebral block(TPVB) is performed 20 minutes before the ablation surgery began,30 mL of 0.375% ropivacaine was totally injected in T3-4 and T5-6 spinal segment（the block segment can be adjusted according to the tumor site) under the ultrasound guidance. |
Who may qualify
- Ages
- 30 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients diagnosed with lung cancer by imaging examination
- Informed consent of the patient and study approval by the Medical Ethics Committee
Key exclusion criteria (3 listed)
- have a history of psychiatric illness, chronic pain, regular analgesic usage
- have contraindications to performing a TPVB, such as chest wall deformity, severe coagulopathy, local infection
- have allergy to local anaesthetic drugs
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 |
|---|---|---|
| RopivacaineThoracic paravertebral block(TPVB) is performed on the patients who undergo the thermal ablation therapy. | Other | Group NB (thoracic paravertebral block Group) |
Primary outcome
The degree of pain that patients feel who undergo ablation surgery is assessed by the visual analog scale (VAS).
Time frame: During surgery
All patients are instructed on the use of the visual analog scale (VAS) for pain assessment before surgery, then anesthetist evaluate the analgesic effect of TPVB for the ablation surgery with the VAS during surgery(0="no pain"and 10=the "worst pain").
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2022.
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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.
Yuan Zhou, Doctor study director
Affiliated Hospital of Nantong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ropivacaine in people with Lung Cancer, run by Affiliated Hospital of Nantong University at 1 site in China.
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 2 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: finished, as of the sponsor's last update on 29 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The degree of pain that patients feel who undergo ablation surgery is assessed by the visual analog scale (VAS). (time frame: During 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 29 Jun 2022.