- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04388423
Study on Application of Simulated Training in Ultrasound Guided Transversus Abdominis Plane Block
July 13, 2020 updated by: Yi Liu, Chinese PLA General Hospital
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 Overview
Status
Unknown
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
240
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Haidian
-
Beijing, Haidian, China, 100853
- Chinese PLA General Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 18-70 years old; ASA 1 ~ 2; patients under non-transvaginal gynecologic surgery, rectal surgery or descending colon surgery
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Group C
|
The residents are trained by traditional bedside teaching
|
EXPERIMENTAL: Group S
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
procedure/surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
May 15, 2020
Primary Completion (ANTICIPATED)
December 31, 2020
Study Completion (ANTICIPATED)
January 1, 2021
Study Registration Dates
First Submitted
May 12, 2020
First Submitted That Met QC Criteria
May 13, 2020
First Posted (ACTUAL)
May 14, 2020
Study Record Updates
Last Update Posted (ACTUAL)
July 14, 2020
Last Update Submitted That Met QC Criteria
July 13, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- PLAGHAOC202003
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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