Transversus Abdominis Plane BlockNCT04388423
Study on Application of Simulated Training in Ultrasound Guided Transversus Abdominis Plane Block
A study testing simulated puncture training and traditional bedside teaching in people with Transversus Abdominis Plane Block and Simulation Training, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
With the development of society and the enhancement of people's awareness of law and self-protection, it is necessary to use simulation technology to create a simulated human and clinical environment to replace the traditional teaching of clinical operation on real patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Transversus Abdominis Plane Block, Simulation Training, Learning Curve
- What is being tested?
- simulated puncture training and traditional bedside teaching
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 15 May 2020to 1 Jan 2021
- 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
- 18-70 years old; ASA 1 ~ 2; patients under non-transvaginal gynecologic surgery, rectal surgery or descending colon surgery
Who cannot join
- Patients with communication disorder Central or peripheral nervous system diseases. Liver and kidney functions seriously damaged Coagulation function abnormality and local anesthetic allergy history Patients with serious heart disease, hypertension and diabetes. Patients who have used analgesic drugs or drugs that may affect cardiovascular function within 24 hours before operation.
- Patients with infection at the puncture site.
Trial locations and contacts
1 site in 1 country.
About this study
With the development of society and the enhancement of people's awareness of law and self-protection, it is necessary to use simulation technology to create a simulated human and clinical environment to replace the traditional teaching of clinical operation on real patients. So simulation teaching is more and more important in medical education. However, simulation teaching is in the ascendant in China, especially in the ultrasound-guided nerve block, limited by the lack of full simulation of puncture model, the simulation training of ultrasound-guided nerve block is not carried out much. Therefore, this study uses simulation training to carry out ultrasound-guided horizontal abdominal muscle block teaching, in order to explore an effective way of ultrasound-guided nerve block teaching.
- Being tested
- simulated puncture training, traditional bedside teaching
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
simulated puncture trainingOther
The residents are trained of simulated puncture : 1.the location puncture; 2. finding fixed-point needle on the model for 5 times, each time for 30 minutes.
traditional bedside teachingOther
The residents are trained by traditional bedside teaching
| Study group | Role | What they receive |
|---|---|---|
| Group S | Experimental | Not described Receives: Other: simulated puncture training |
| Group C | Experimental | Not described Receives: Other: traditional bedside teaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
The time taken to complete the blocking operation
After finishing the disinfection sheet, the operator began to perform unilateral transversal muscle planar ultrasound scanning, positioning and puncture until the end of injection.
Measured: procedure/surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2020
- Study start15 May 2020
- Primary completion31 Dec 2020 (estimated)
- Study completion1 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transversus Abdominis Plane BlockStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi Liu, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04388423
- Sponsor's protocol ID
- PLAGHAOC202003
- Status last verified
- Jul 2020
- First submitted
- 12 May 2020
- Last updated
- 14 Jul 2020
- 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 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Application of Simulated Training in Ultrasound Guided Transversus Abdominis Plane Block
- ClinicalTrials.gov ID
- NCT04388423
- Acronym / sponsor ID
- PLAGHAOC202003
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 15 May 2020 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 1 Jan 2021 (estimated)
- First posted
- 14 May 2020 (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.
With the development of society and the enhancement of people's awareness of law and self-protection, it is necessary to use simulation technology to create a simulated human and clinical environment to replace the traditional teaching of clinical operation on real patients. So simulation teaching is more and more important in medical education. However, simulation teaching is in the ascendant in China, especially in the ultrasound-guided nerve block, limited by the lack of full simulation of puncture model, the simulation training of ultrasound-guided nerve block is not carried out much. Therefore, this study uses simulation training to carry out ultrasound-guided horizontal abdominal muscle block teaching, in order to explore an effective way of ultrasound-guided nerve block teaching.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group S | Experimental | Other: simulated puncture training |
| Group C | Experimental | Other: traditional bedside teaching |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18-70 years old; ASA 1 ~ 2; patients under non-transvaginal gynecologic surgery, rectal surgery or descending colon surgery
Key exclusion criteria (2 listed)
- Patients with communication disorder Central or peripheral nervous system diseases. Liver and kidney functions seriously damaged Coagulation function abnormality and local anesthetic allergy history Patients with serious heart disease, hypertension and diabetes. Patients who have used analgesic drugs or drugs that may affect cardiovascular function within 24 hours before operation.
- Patients with infection at the puncture site.
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 |
|---|---|---|
| simulated puncture trainingThe residents are trained of simulated puncture : 1.the location puncture; 2. finding fixed-point needle on the model for 5 times, each time for 30 minutes. | Other | Group S |
| traditional bedside teachingThe residents are trained by traditional bedside teaching | Other | Group C |
Primary outcome
The time taken to complete the blocking operation
Time frame: procedure/surgery
After finishing the disinfection sheet, the operator began to perform unilateral transversal muscle planar ultrasound scanning, positioning and puncture until the end of injection.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing simulated puncture training and traditional bedside teaching in people with Transversus Abdominis Plane Block and Simulation Training, run by Chinese PLA General Hospital 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 1 inclusion and 2 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 Jul 2020. 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?
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 time taken to complete the blocking operation (time frame: procedure/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 14 Jul 2020.