| CTRI Number |
CTRI/2024/08/072786 [Registered on: 20/08/2024] Trial Registered Prospectively |
| Last Modified On: |
12/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
the participants posted for surgery under spinal anaesthesia will be intervened by ultrasonography before giving spinal anaesthesia and the outcome of the procedure will be compared to the conventional spinal anaesthesia technique |
|
Scientific Title of Study
|
A study to compare preprocedural ultrasound versus landmark technique for spinal anesthesia. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sumaiyya fatima |
| Designation |
Post graduate student |
| Affiliation |
Mahadevappa rampure medical college |
| Address |
Department of anaesthsiology, Basaveshwara teaching and general hospital attached to Mahadevappa rampure medical college, Kalaburagi karnataka. Department of Anaesthesiology, Basaveshwara teaching and general hospital, attached to Mahadevappa Rampure Medical College,sedam road,rajapur Kalaburagi, Karnataka-585105. Gulbarga KARNATAKA 585105 India |
| Phone |
|
| Fax |
|
| Email |
sumaiyafatima68r@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Lata D shetty |
| Designation |
Professor |
| Affiliation |
M.R. medical college gulbarga |
| Address |
Department of Anaesthesiology, Basaveshwara teaching and
general hospital, attached to Mahadevappa Rampure Medical College,sedam road,rajapur Kalaburagi, Karnataka -585105.
Gulbarga KARNATAKA 585105 India |
| Phone |
9731046446 |
| Fax |
|
| Email |
latads@yahoo.co.in |
|
Details of Contact Person Public Query
|
| Name |
Lata D shetty |
| Designation |
Professor |
| Affiliation |
M.R. medical college gulbarga |
| Address |
Department of Anaesthesiology, Basaveshwara teaching and general hospital, attached to Mahadevappa Rampure Medical College,sedam road,rajapur Kalaburagi, Karnataka-585105.
Gulbarga KARNATAKA 585105 India |
| Phone |
9731046446 |
| Fax |
|
| Email |
latads@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, Basaveshwara teaching and general hospital, attached to Mahadevappa Rampure Medical College,sedam road,rajapur Kalaburagi, Karnataka-585105, India. |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology, Basaveshwara teaching and general hospital |
| Address |
Department of Anaesthesiology, Basaveshwara teaching and
general hospital, attached to Mahadevappa Rampure Medical College Kalaburagi Sedam Rd, Rajapur, Kalaburagi, Karnataka 585105 |
| 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 Lata D Shetty |
Basaveshwara Hospital |
Department of anaesthesia, 1st floor major operation theatre. Gulbarga KARNATAKA |
9731046446
latads@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethical committee M.R. Medical college, kalaburagi |
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 |
landmark technique |
use of landmark technique to establish spinal anaesthesia |
| Intervention |
Use of ultrasonography for spinal anaesthesia |
Use of ultrasonography compared with landmark technique for spinal anaesthesia administration till successful spinal anaesthesia is established. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. American Society of Anaesthesiologists grade I and II patients.
2. Patients of all genders between the ages of 18-60 years.
3. Patients undergoing elective surgeries under spinal anaesthesia. |
|
| ExclusionCriteria |
| Details |
1. Patients with history of allergy to drugs used in the study.
2. Pregnant and lactating patients.
3. Patients with any infection at the site of injection and spine deformity. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| successful spinal anaesthesia in Preprocedural Ultrasound (US) group and landmark technique group. |
during spinal anaesthesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The number of needle puncture attempt and duration taken to establish
successful spinal anaesthesia in Preprocedural Ultrasound (US) group and Landmark Technique (LM) group. |
during spinal anaesthesia |
|
|
Target Sample Size
|
Total Sample Size="110" Sample Size from India="110"
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)
|
30/08/2024 |
| 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)
|
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 - NO
|
|
Brief Summary
|
The ideal technique for spinal anaesthesia requires successful dural puncture with single spinal needle pass. Spinal anaesthesia is traditionally performed by palpation of bony landmarks to identify the level of needle insertion using the intercristal line as a guide for identifying L4 (4th lumbar vertebrae) or L4-5 space, but in females and patients with higher body mass indices the level may vary to L3 (3rd lumbar vertebrae) or L3-4 space, causing difficulty to predict the level Frequent attempts during lumbar puncture causes cerebrospinal fluid leakage which is associated with increased incidence of Post Dural Puncture Headache (PDPH). Studies have shown that pre-procedural ultrasound facilitates first attempt success rate in elderly patients, hence use of ultrasonography (USG) will decrease the number of attempts and incidence of PDPH by increasing the first attempt success rate. Recently ultrasound imaging has become a popular tool among anaesthesiologists in operation theatres and intensive care units. USG is widely used in operation theatres for nerve blocks but has still taken a backseat when it comes to neuraxial blocks. USG during the neuraxial blocks usually increases procedural duration making the procedure more intricate. Many studies for USG guided paramedian approach are conducted whereas very few studies are done for routine USG guided midline approach, hence the present study “A STUDY TO COMPARE PREPROCEDURAL ULTRASOUND VERSUS LANDMARK TECHNIQUE FOR SPINAL ANESTHESIA’’ will be conducted to fill this lacune with the hypothesis that Preprocedural USG reduces the number of attempts, reduces the procedural time, reduces the number of needle punctures and PDPH in patients. |