CTRI Number |
CTRI/2018/02/012133 [Registered on: 23/02/2018] Trial Registered Retrospectively |
Last Modified On: |
02/12/2019 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Does a Pre-Procedural Ultrasound Of the spine Improve The Performance For Spinal Anaesthesia |
Scientific Title of Study
|
Efficacy Of Pre-Procedural Ultrasound Of Lumbar Spine In Improving The Procedural Skill For Subarachnoid Block |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
P R Arthi |
Designation |
Post Graduate |
Affiliation |
Mahatma Gandhi Medical College and Research Institute |
Address |
Department of Anaesthesiology
Mahatma Gandhi Medical College and Research Institute
Pillaiyarakuppam
Puducherry
Pondicherry PONDICHERRY 607402 India |
Phone |
|
Fax |
|
Email |
arthi.pre@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Archana Areti |
Designation |
Assistant Professor |
Affiliation |
Mahatma Gandhi Medical College and Research Institute |
Address |
Department of Anaesthesiology
Mahatma Gandhi Medical College and Research Institute
Pillaiyarakuppam
Puducherry
Pondicherry PONDICHERRY 607402 India |
Phone |
|
Fax |
|
Email |
archanaareti@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Archana Areti |
Designation |
Assistant Professor |
Affiliation |
Mahatma Gandhi Medical College and Research Institute |
Address |
Department of Anaesthesiology
Mahatma Gandhi Medical College and Research Institute
Pillaiyarakuppam
Puducherry
Pondicherry PONDICHERRY 607402 India |
Phone |
|
Fax |
|
Email |
archanaareti@gmail.com |
|
Source of Monetary or Material Support
|
Mahatma Gandhi Medical College and Research Institute
Pillaiyarakuppam
Puducherry - 607402 |
|
Primary Sponsor
|
Name |
Department Of Anaesthesiology |
Address |
Mahatma Gandhi Medical College and research Institute
Pillaiyarakuppan
Puducherry |
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 |
Archana Areti |
Mahatma Gandhi Medical College and Research Institute |
Department of anaesthesiology
Pillaiyarakuppam
Puducherry Pondicherry PONDICHERRY |
8374237095
archanaareti@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Insitutional Human Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
Patients posted for elective surgery under spinal anaesthesia, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
LM |
Landmark based technique of Spinal Anaesthesia |
Intervention |
US |
USG scanning and skin marking of the lumbar spine prior to performing spinal anaesthesia |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
75.00 Year(s) |
Gender |
Both |
Details |
ASA Grade I and II |
|
ExclusionCriteria |
Details |
1) patient refusal
2) Contraindication for spinal anaesthesia – infection at site, coagulopathy, allergy to local anaesthetics
3) Spinal Deformity
4) BMI>35, Pregnancy
5) Previous Spine Surgery
6) Lower Limb Fractures
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
procedural success in first needle pass |
procedural success in first needle pass |
|
Secondary Outcome
|
Outcome |
TimePoints |
number of needle passes |
the number of forward advancements of the spinal needle in a given interspinous space, i.e., withdrawal and redirection of spinal needle without exiting the skin |
The number of attempts defined as the number of times the spinal needle is withdrawn from the skin and reinserted |
defined as the number of times the spinal needle is withdrawn from the skin and reinserted
A maximum of 3 attempts will be allowed for the performer. After 3 attempts, it will be considered as a procedural failure, following which the Senior anaesthesiologist will intervene |
The time taken to detect CSF |
time from first needle insertion till CSF detection |
|
Target Sample Size
|
Total Sample Size="200" Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "200"
Final Enrollment numbers achieved (India)="200" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
01/03/2017 |
Date of Study Completion (India) |
14/08/2018 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="2" Months="4" Days="4" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
none yet |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Spinal
anaesthesia is one of the commonest procedures performed, and one of the first
skills to be acquired by an anaesthesiologist.
It requires considerable skill, and demands a precise and total
understanding of regional anatomic relationships. Acquiring adequate knowledge of the anatomy
and orientation of central neuraxis, for performance of a successful block, is
still largely based on the “blind†landmark based procedure. Radiological examination and simulation based
training techniques have been employed successfully, to better aid the teaching
process.
In recent times, Ultrasonography has shed
light in various aspects in clinical anaesthesia, and has proven to be a useful
tool for point of care procedures.
Pertaining to central neuraxial blockade, USG guided procedures have
been proven to identify and navigate the difficult anatomy, but
because the procedure is time taking and there pose some difficulty in
obtaining clear images, it is not routinely used in clinical practise. However in a setting where practise makes
perfect, to include its application as a teaching tool for the normal anatomy,
may prove to improve the technique of lumbar puncture for spinal anaesthesia in
normal as well as difficult anatomy, thereby reducing the distress experienced
by the patient with multiple attempts at spinal anaesthesia, also reducing
incidence of associated complications (e.g hematoma, post dural puncture
headache) . This study is
designed to evaluate if a preprocedural ultrasonographic examination of the lumbar
spine, improves the performance of lumbar puncture for spinal anaesthesia.
|