Thoracic AnesthesiaNCT04829409
The Effects of Three Different Ultrasound-guided Nerve Blocks in VATS
A study testing Paravertebral block, ESP block and MTP block in people with Thoracic Anesthesia and Nerve Block, run by Huazhong University of Science and Technology at 1 site in China.
Trial summary
Ultrasound-guided mid-point transverse process to pleura block, erector spinae plane block and paravertebral block are three different methods of nerve block, used for relieving postoperative pain in thoracic anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Thoracic Anesthesia, Nerve Block, Pain, Acute
- What is being tested?
- Paravertebral block, ESP block and MTP block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 5 Apr 2021to Dec 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- selective lobetomy under VATS
- ASA classfication 1-3
Who cannot join
- history of thoracic surgery
- double lateral VATS
- allergy to local anesthetics
- coagulation disorders
- severe heart diseases, hepatic or renal insufficiency
- a history of chronic pain or chronic opioid use
Show all 9Show fewer
- psychiatric disease or uncooperative
- BMI>28 kg/m2
- VATS transfered to open thoractomy
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tongji Hospital, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Ailin Luo, Ph.D.,M.D., +86-27-83663282, alluo@tjh.tjmu.edu.cn
Wenlong Yao, Ph.D.,M.D.
About this study
Official title: The Effects of Ultrasound-guided Mid-point Transverse Process to Pleura Block, Erector Spinae Plane Block and Paravertebral Block on Postoperative Pain in Video-assisted Thoracic Surgery
Ultrasound-guided mid-point transverse process to pleura block, erector spinae plane block and paravertebral block are three different methods of nerve block, used for relieving postoperative pain in thoracic anesthesia. This study is to compare them on block effects, postoperative pain and analgesic consumption in video-assisted thoracic surgery.
Read the detailed description
Ultrasound-guided nerve block is an important part of multi-mode analgesia to decrease the consumption of opioids. Thoracic paravertebral block is considered as an ideal regional analgesic choice for video-assisted thoracic surgery, but it still has some side effects, such as pneumothorax, vascular injury, especially for novices. Recent years, ultrasound-guided mid-point transverse process to pleura block and erector spinae plane block are reported for thoracic surgery. The insertion depth in these two methods is more superficial than traditional paravertebral block. They could have less side effects. Therefore, we design a randomised control study to compare them on block effects, postoperative pain and analgesic consumption in video-assisted thoracic surgery.
- Conditions
- Thoracic Anesthesia, Nerve Block, Pain, Acute
- Being tested
- Paravertebral block, ESP block, MTP block
- Keywords
- ultrasound-guided nerve block, postoperative pain
- Medical subject headings
- Acute Pain, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paravertebral blockProcedure or surgery
Patients receive ultrasound-guided paravertebral block
ESP blockProcedure or surgery
Patients receive ultrasound-guided erector spinae plane (ESP) block
MTP blockProcedure or surgery
Patients receive ultrasound-guided mid-point transverse process to pleura (MTP) block
| Study group | Role | What they receive |
|---|---|---|
| paravertebral block | Active comparator | Patients receive ultrasound-guided paravertebral block Receives: Procedure: Paravertebral block |
| ESP block | Active comparator | Patients receive ultrasound-guided erector spinae plane (ESP) block Receives: Procedure: ESP block |
| MTP block | Experimental | Patients receive ultrasound-guided mid-point transverse process to pleura (MTP) block Receives: Procedure: MTP block |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative morphine consumption
The dose is according to the record from PCA pump
Measured: postoperative 24 hours
Secondary outcomes (2)
Pain score at rest
measured by VAS (0-10)
Measured: at 0, 8, 24 hour after surgery
Pain score while coughing
measured by VAS (0-10)
Measured: at 0, 8, 24 hour after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2021
- Study start5 Apr 2021
- Primary completionOct 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic AnesthesiaStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wenlong Yao, Huazhong University of Science and Technology
- Investigators
- Ailin Luo, MD,PhD, Study chair, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04829409
- Sponsor's protocol ID
- TJMZK20210301
- Status last verified
- Apr 2022
- First submitted
- 30 Mar 2021
- Last updated
- 14 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Ultrasound-guided Mid-point Transverse Process to Pleura Block, Erector Spinae Plane Block and Paravertebral Block on Postoperative Pain in Video-assisted Thoracic Surgery
- ClinicalTrials.gov ID
- NCT04829409
- Acronym / sponsor ID
- TJMZK20210301
- Conditions
- Thoracic Anesthesia, Nerve Block, Pain, Acute
- Keywords
- ultrasound-guided nerve block, postoperative pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 5 Apr 2021 (actual)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 2 Apr 2021 (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.
Ultrasound-guided mid-point transverse process to pleura block, erector spinae plane block and paravertebral block are three different methods of nerve block, used for relieving postoperative pain in thoracic anesthesia. This study is to compare them on block effects, postoperative pain and analgesic consumption in video-assisted thoracic surgery.
Detailed description
Ultrasound-guided nerve block is an important part of multi-mode analgesia to decrease the consumption of opioids. Thoracic paravertebral block is considered as an ideal regional analgesic choice for video-assisted thoracic surgery, but it still has some side effects, such as pneumothorax, vascular injury, especially for novices. Recent years, ultrasound-guided mid-point transverse process to pleura block and erector spinae plane block are reported for thoracic surgery. The insertion depth in these two methods is more superficial than traditional paravertebral block. They could have less side effects. Therefore, we design a randomised control study to compare them on block effects, postoperative pain and analgesic consumption in video-assisted thoracic surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| paravertebral block | Active comparator | Procedure: Paravertebral blockPatients receive ultrasound-guided paravertebral block |
| ESP block | Active comparator | Procedure: ESP blockPatients receive ultrasound-guided erector spinae plane (ESP) block |
| MTP block | Experimental | Procedure: MTP blockPatients receive ultrasound-guided mid-point transverse process to pleura (MTP) block |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- selective lobetomy under VATS
- ASA classfication 1-3
Key exclusion criteria (9 listed)
- history of thoracic surgery
- double lateral VATS
- allergy to local anesthetics
- coagulation disorders
- severe heart diseases, hepatic or renal insufficiency
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 |
|---|---|---|
| Paravertebral blockPatients receive ultrasound-guided paravertebral block | Procedure or surgery | paravertebral block |
| ESP blockPatients receive ultrasound-guided erector spinae plane (ESP) block | Procedure or surgery | ESP block |
| MTP blockPatients receive ultrasound-guided mid-point transverse process to pleura (MTP) block | Procedure or surgery | MTP block |
Primary outcome
postoperative morphine consumption
Time frame: postoperative 24 hours
The dose is according to the record from PCA pump
2 secondary outcomes
Pain score at rest
Time frame: at 0, 8, 24 hour after surgery
Pain score while coughing
Time frame: at 0, 8, 24 hour after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 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.
Ailin Luo, MD,PhD study chair
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paravertebral block, ESP block and MTP block in people with Thoracic Anesthesia and Nerve Block, run by Huazhong University of Science and Technology 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 9 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 14 Apr 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wenlong Yao, MD (86-27-83663173, wlyao82@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative morphine consumption (time frame: postoperative 24 hours). 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 14 Apr 2022.