| CTRI Number |
CTRI/2023/05/052966 [Registered on: 22/05/2023] Trial Registered Prospectively |
| Last Modified On: |
28/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to observe and correlate the depth of needle insertion during spinal anesthesia measured using ultrasound and actual depth of needle insertion |
|
Scientific Title of Study
|
Correlation between
depth of skin to subarachnoid space in the lumbar region measured using ultrasound and depth of needle insertion - A
Prospective observational study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Thameem Ahamed M |
| Designation |
1st year Post-Graduate |
| Affiliation |
Sri Manakula Vinayagar medical college and hospital |
| Address |
Department of Anaesthesiology,
Sri Manakula Vinayagar medical college and hospital,
kalitheerthalkuppam,
Madagadipet,
Puducherry
Pondicherry
PONDICHERRY
605107
India |
| Phone |
9344144044 |
| Fax |
|
| Email |
thameemahamed@outlook.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Thameem Ahamed M |
| Designation |
1st year Post-Graduate |
| Affiliation |
Sri Manakula Vinayagar medical college and hospital |
| Address |
Department of Anaesthesiology,
Sri Manakula Vinayagar medical college and hospital,
kalitheerthalkuppam,
Madagadipet,
Puducherry
Pondicherry
PONDICHERRY
605107
India |
| Phone |
9344144044 |
| Fax |
|
| Email |
thameemahamed@outlook.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suneeth P Lazarus |
| Designation |
Head of the department |
| Affiliation |
Sri Manakula Vinayagar medical college and hospital |
| Address |
Department of Anaesthesiology,
Sri Manakula Vinayagar medical college and hospital,
kalitheerthalkuppam,
Madagadipet,
Puducherry
Pondicherry
PONDICHERRY
605107
India |
| Phone |
9894332543 |
| Fax |
|
| Email |
lazarus.suneeth@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Manakula vinayagar medical college and hospital ,
kalitheerthalkuppam,
madagadipet, pududchery -605107 |
|
|
Primary Sponsor
|
| Name |
Dr.Thameem Ahamed M |
| Address |
1st Year Post graduate,
Sri Manakula vinayagar medical college and hospital , kalitheerthalkuppam, madagadipet, pududchery -605107
|
| Type of Sponsor |
Other [Self] |
|
|
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 Thameem Ahamed M |
Sri Manakula vinayagar medical college and hospital |
Department of Anaesthesiology,
Sri Manakula Vinayagar medical college and hospital,
kalitheerthalkuppam,
Madagadipet,
Puducherry
Pondicherry
PONDICHERRY |
09344144044
thameemahamed@outlook.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMVMCH - ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients who are willing to give consent
2. Age between 18 and 60 years of age
3. Participants of either Gender
4. ASA grade I or II
5. Patients posted for Elective surgeries under Spinal Anaesthesia |
|
| ExclusionCriteria |
| Details |
1. Participants who are not willing to give consent for spinal anaesthesia
2. Absolutely contraindicated conditions for spinal anaesthesia
3. Participants with spinal abnormalities will be excluded
4. Emergency surgeries.
5. Height less than 150cms |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
the mean
and standard deviation of subarachnoid space depth measured by
ultrasonography and depth of needle insertion |
at end of procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare measurements from ultrasound and depth of needle insertion with
stocker’s formula.
|
at the baseline |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
28/05/2023 |
| 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="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
nil |
|
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
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [thameemahamed@outlook.com].
- For how long will this data be available start date provided 07-05-2023 and end date provided 07-03-2026?
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
|
After getting approval from the Research committee and Ethics committee of the institute,
written informed consent will be obtained from the individuals who are going to undergo
surgery under spinal anaesthesia. The study will be done under Department of Anaesthesia,
Sri Manakula Vinayagar Medical College and Hospital.
The nature of the study will be thoroughly informed to the participants and their attenders and
the participants who satisfy the inclusion criteria only will be enrolled strictly.
The study will be conducted in the hospital premises after fixing and posted for surgery. Pre
operative assessment is done in PAC clinic and re-assessment will be done previous evening
before the surgery.
The relevant clinical information on BMI, previous surgery histories, airway assessments,
history on CVA and MI will been recorded. The participant’s height, weight and BMI will be
recorded using calibrated equipment.
Procedure
- Patient will be kept in NPO for 8 hours
- Premedication given T.Alprazolam 0.5mg and T.Pantoprazole 40mg night before the
surgery.
- Informed written consent will be obtained from each of the participants enrolled. The
data of the participants will be recorded in the proforma. Details like age, sex, contact
information, comorbidities, airway assessment, spine assessment and ASA class will
be recorded.
On the day of surgery participant will be transferred from ward to OT Patients waiting room.
There they will be pre assessed 1 hour before surgery. The patient will be shifted to the OT
and necessary monitoring equipment will be attached like non-invasive BP, Pulse oximeter,
electrocardiography monitors will be attached and connected. A peripheral I.V line will be
secured under SAP.
Base line parameters like heart rate, SpO2 and non-invasive blood pressure will be recorded.
IV fluids will be connected, after that participant will be made sit in the table and Using
ultrasonography measurements will be measured using SONOSITE ultrasound system with 2
– 5 MHz probe curvilinear array transducer will be placed by the observer 2 in a median
sagittal plane over the sacrum to visualize the hyperechoic line corresponding to the image of
the sacrum. The probe will be moved cephalad in the same plane to visualize the various
interspinous spaces till the L3–L4 interspace encountered. A transverse scan will be
performed. The L3–L4 interspinous space will be identified by moving the probe slowly
cephalad or caudad to obtain the absence of after shadow and the view of the complex formed
by the ligamentum flavum-dura mater and to find the vertebral body. The outlines of the
various targets will be drawn with a sterile dermographic pen. The optimum sonogram will
be taken picture and recorded. With the use of built-in calliper the distance from the skin to
the anterior part of the ligamentum flavum-dura mater complex, the bottom limit before
reaching intrathecal space, will be measured.
For the purpose of study the SSD will be calculated by using Stocker’s formula [SSD (mm)
=0.5 × weight (kg) +18] and recorded
After the successful ultrasonography measurement. The patient will be made to sit in the
table by the help of nurse assistants. The lumbar sacral region of the participant will be
painted and draped by using povidone iodine and spirit. The l3-l4 space will be palpated by
manual palpatory method. After infiltrating the space with 2% LIGNOCAINE
subcutaneously, using a 23G Quincke’s needle a lumbar puncture will be done and the needle
will be advanced till the needle placed in sub arachnoid space. After checking the free flow of
cerebrospinal fluid, 0.5% hyperbaric Bupivacaine of required amount pertaining to case will
be injected intrathecally at the rate of 0.2ml/second. And then the spinal needle will be
withdrawn by marking the point with a sterile marker and depth will be measured using a
measuring scale. After that patient will be kept in supine position and continuous vigilant
monitoring of the vitals will be done. The level of blockade of sensory and motor blockade
will be tested every two minutes till it reaches highest level of level of blockade. Pin-Prick
test will be used to assess the sensory blockade and will be scored according to a three-point
scale in the dermatomes. Motor Blockade is assessed using Modified Bromage scale.
Hemodynamic parameters will be recorded every 10 minutes prior to the procedure and the
every 5 mins during procedures for first 30 minutes and every 10 minutes from next hours.
Heart rate of less than 50bpm will be managed by administration of injection atropine 0.6mg
i.v and hypotension will be considered if mean arterial pressure is less than 20% and if so will
be managed by injection EPHEDRINE 6MG iv.
Any adverse reactions will be vigilantly seen, noted if any and treated accordingly.
INJ.PARACETAMOL 15MG/KG will be used as peri operative analgesia. If there is any
adverse events it will be informed to respected ethics committee within 24 hours of
occurrence of the event |