| CTRI Number |
CTRI/2024/08/071978 [Registered on: 06/08/2024] Trial Registered Prospectively |
| Last Modified On: |
31/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare ease of spinal needle insertion for anaesthesia in different positions |
|
Scientific Title of Study
|
Comparison of sitting and lateral decubitus position for ease of spinal needle insertion during lumbar intrathecal anaesthesia
A prospective randomized study. |
| 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 R Sridevi |
| Designation |
Associate Professor |
| Affiliation |
Sri Venkateswara Institute of Medical Sciences |
| Address |
Associate Professor, Department of Anaesthesiology, Sri Venkateswara Institute of Medical Sciences, Valmiki circle, Tirupati, Chittoor district, Chittoor, Andhra Pradesh.
Chittoor
ANDHRA PRADESH
517501
India |
| Phone |
9493547661 |
| Fax |
|
| Email |
sridevi.radhapuram@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr R Sridevi |
| Designation |
Associate Professor |
| Affiliation |
Sri Venkateswara Institute of Medical Sciences |
| Address |
Associate Professor, Department of Anaesthesiology, Sri Venkateswara Institute of Medical Sciences, Valmiki circle, Tirupati, Chittoor district, Chittoor, Andhra Pradesh.
ANDHRA PRADESH
517501
India |
| Phone |
9493547661 |
| Fax |
|
| Email |
sridevi.radhapuram@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ghanta Bhargavi Sri Ramya |
| Designation |
Post graduate |
| Affiliation |
Sri Venkateswara Institute of Medical Sciences |
| Address |
Post graduate, Sri Venkateswara Institute of Medical Sciences, Valmiki circle, Tirupati, Chittoor district, Chittoor, Andhra Pradesh
Chittoor
ANDHRA PRADESH
Chittoor
ANDHRA PRADESH
517501
India |
| Phone |
9959519812 |
| Fax |
|
| Email |
gbsrs7m@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Venkateswara Institute of Medical Sciences, Valmiki circle, Alipiri road, Tirupati, Chittoor district, Andhra Pradesh, India
PIN code: 517501 |
|
|
Primary Sponsor
|
| Name |
Sri Venkateswara Institute of Medical Sciences |
| Address |
Sri Venkateswara Institute of Medical Sciences, Valmiki circle, Alipiri road, Tirupati, Chittoor district, Andhra Pradesh, India
PIN code: 517501 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 R Sridevi |
Sri Venkateswara Institute of Medical Sciences |
Department of Anaesthesiology, Svims, Valmiki circle, Tirupati
Chittoor
ANDHRA PRADESH
Chittoor
ANDHRA PRADESH |
9493547661
sridevi.radhapuram@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Sri Venkateswara Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Spinal anaesthesia in lateral decubitus position |
These patients will undergo spinal anaesthesia in lateral decubitus position
Duration- until appearance of free flow of cerebrospinal fluid at the needle hub |
| Intervention |
Spinal anaesthesia in traditional sitting position |
These patients will undergo spinal anaesthesia in traditional sitting position
Duration - until appearance of free flow of cerebrospinal fluid at the needle hub |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing lower abdomen, pelvic and lower limb surgeries under lumbar intrathecal anaesthesia
Patients coming under American Society of Anesthesiologists Physical Status- â… , â…¡, â…¢
|
|
| ExclusionCriteria |
| Details |
1) Refusal to give informed consent
2) Body Mass Index (BMI) more than or equal to 30 kg per meter square
3) Patients with coagulation abnormalities
4) Patients with psychiatric and neurological
disorders
5) Patients unable to flex their knees and hips
6) Patients with any contraindication to lumbar
intrathecal anaesthesia
7) Patients with spine deformities
8) Pregnant and Lactating women
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The number of spinal needle - bone contacts |
During the procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
(1)Ease of landmark palpation
(2)Successful insertion of spinal needle into lumbar intrathecal space
(3)Number of attempts
(4)Incidence of postdural puncture headache
|
(1)During procedure
(2)During procedure
(3)During procedure
(4)Postoperatively for 5 days
|
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
20/08/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/08/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 - NO
|
|
Brief Summary
|
In this prospective randomized trial we will be recruiting 80 patients who will be divided randomly into two groups of 40 each. One group will be administered lumbar intrathecal anaesthesia in the traditional sitting position and the other group in lateral decubitus position. We will assess for number of spinal needle bone contacts, ease of landmark palpation, success of spinal needle insertion into lumbar intrathecal space, number of attempts, incidence of postdural puncture headache postoperatively. |