| CTRI Number |
CTRI/2025/01/078842 [Registered on: 16/01/2025] Trial Registered Prospectively |
| Last Modified On: |
28/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessment of ultrasonographic skills of novices in identification of structures in ultrasound guided nerve block in axilla (underarm). |
|
Scientific Title of Study
|
Assessment of sonographic skills of novices for identification of anatomical structures in ultrasound guided axillary brachial plexus block |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr S SUGANYA |
| Designation |
Assistant Professor |
| Affiliation |
Sri Venkateshwaraa Medical College Hospital and Research Centre |
| Address |
Department of Anaesthesiology and Critical Care Sri Venkateshwaraa Medical College Hospital and Research Centre Ariyur Puducherry Ariyur Puducherry Pondicherry PONDICHERRY 605009 India |
| Phone |
9940369193 |
| Fax |
|
| Email |
drssuganya@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr S SUGANYA |
| Designation |
Assistant Professor |
| Affiliation |
Sri Venkateshwaraa Medical College Hospital and Research Centre |
| Address |
Department of Anaesthesiology and Critical Care Sri Venkateshwaraa Medical College Hospital and Research Centre Ariyur Puducherry Ariyur Puducherry Pondicherry PONDICHERRY 605009 India |
| Phone |
9940369193 |
| Fax |
|
| Email |
drssuganya@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr S SUGANYA |
| Designation |
Assistant Professor |
| Affiliation |
Sri Venkateshwaraa Medical College Hospital and Research Centre |
| Address |
Department of Anaesthesiology and Critical Care Sri Venkateshwaraa Medical College Hospital and Research Centre Ariyur Puducherry Ariyur Puducherry Pondicherry PONDICHERRY 605009 India |
| Phone |
9940369193 |
| Fax |
|
| Email |
drssuganya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Venkateshwaraa Medical College Hospital and Research Centre Puducherry |
|
|
Primary Sponsor
|
| Name |
Sri Venkateshwaraa Medical College Hospital and Research Centre, Puducherry |
| Address |
Department of Anaesthesiology and Critical Care, Second floor, Hosital block, Sri Venkateshwaraa Medical College Hospital and Research Centre, Ariyur, Puducherry-605107 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr S Suganya |
Sri Venkateshwaraa Medical College Hospital and Research Centre |
Department of Anaesthesiology and Critical Care, Operation theatre complex, second floor, Sri Venkateshwaraa Medical College Hospital and Research Centre Ariyur Puducherry Pondicherry PONDICHERRY |
9940369193
drssuganya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (Human Studies) Sri Venkateshwaraa Medical College Hospital and Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
This is an observational study to assess the ultrasound skills of postgraduate students |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Not Applicable |
Not Applicable |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Postgraduate resident trainee doctors from the department of Anaesthesiology in our Institute who have performed less than 5 ultrasound guided regional anaesthesia procedures |
|
| ExclusionCriteria |
| Details |
Resident doctors who are not willing to participate |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Frequency of correct identification of median, ulnar, radial and musculocutaneous nerves by novices while scanning with ultrasound for axillary brachial plexus block |
images saved and assessed at the end of the scanning procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Frequency of correct identification of axillary artery, axillary vein and conjoint tendon by novices while scanning for axillary brachial plexus block |
Images will be saved and assessed at the end of the scanning procedure |
| Time taken to identify the seven structures in the sonoanatomy of axillary brachial plexus region |
At the end of the scanning procedure |
|
|
Target Sample Size
|
Total Sample Size="22" Sample Size from India="22"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
31/01/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drssuganya@gmail.com].
- For how long will this data be available start date provided 18-10-2025 and end date provided 17-09-2028?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The axillary approach of brachial plexus block (AxBPB) is preferred for its relative safety and ease to perform and commonly performed for providing anesthesia and analgesia involving upper limb procedures below elbow like distal forearm, wrist and hand surgeries. Ultrasound guidance has helped not only in minimizing complications like inadvertent vascular puncture and neural injury, but also in improving block success and reduction in dose of local anesthetic requirement because of real-time visualization and drug deposition close to nerves. The information on the ability of novices to quickly and accurately identify the essential structures one needs to know while performing an AxBPB is scarce. This will provide insight into the aspects of education and training needed to impart the requisite knowledge for novices and aid in structured competency-based training before they perform ultrasound guided axillary block. This study aims to assess the accuracy and time taken for sonoanatomy identification of essential anatomical structures in the axillary brachial plexus block by novices. Informed consent will be obtained from the 22 first- and second-year postgraduate students assessed to be eligible based on their ultrasound experience of performing less than five nerve blocks. The recruited resident doctors will be given training including structured e-learning tutorials, didactic lectures on ultrasound machine and physics, anatomy, ergonomics, scanning technique and sonoanatomy of axillary brachial plexus block, and hands-on volunteer scanning, by the investigator experienced with the technique. The students will then move on to scan the patients coming for elective surgeries before the start of their respective surgeries. Adult patients between the ages of 18-60 years coming for elective surgery will be recruited after obtaining written, informed consent. Obese individuals (BMI ≥ 30kg/m2) with any anatomical or pathological abnormality in the axillary area will be excluded. Performing the axillary block is not a part of this study. Participants other than the one performing the scan will not observe the procedure or be present in the scanning room. The side of the subject to be scanned will be randomised using a block randomisation table. The scanning will be performed using a same machine with a high-frequency (6-13MHz) linear transducer (Sonosite Edge II, Bothell, USA). Before the trainees perform the scan, the blinded investigator will scan to identify the structures and its relation, to rule out any anatomical variation. The resident doctors will be briefed about the structures to be identified with respect to axillary brachial plexus block, including median nerve, ulnar nerve, radial nerve and musculocutaneous nerve, axillary artery, axillary vein and conjoint tendon of lattisimus dorsi and teres major. Once they identify the structures, they will be asked to freeze the image and point the structure and label them before saving the image. They can unfreeze and proceed to identify other structures and continue to label them in a similar manner until all seven structures are identified and marked. They can identify and label multiple structures at a time too. Also, the time taken to identify will be noted in seconds, from the start of scanning to the time when the image was frozen to label a particular structure. The participants will not be corrected or provided feedback during or after performing the scan. The data will be collected by an anesthesiologist who is not a part of the data analysis. The images will be saved and reviewed later as correct or incorrect identification by the principal investigator experienced in ultrasound guided regional anesthesia, blinded to the person performing the scan. Failure to mark any structure will be interpreted as incorrect identification. |