| CTRI Number |
CTRI/2021/06/034193 [Registered on: 11/06/2021] Trial Registered Prospectively |
| Last Modified On: |
10/06/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Usage Of Ultrasound In Betterment Of Spinal Anesthesia Technique |
|
Scientific Title of Study
|
A Study To Test The Efficacy And Safety Of Pre Procedure Ultrasound Guided Paramedian Technique As Compared To Conventional Landmark Guided Paramedian Technique In Administering Spinal Anesthesia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sankalpa Saha |
| Designation |
Junior Resident |
| Affiliation |
BLDE (DU) UNIVERSITY |
| Address |
Department of anesthesia, Shri BM Patil Medical College, BLDE Univ, Vijayapura
Bijapur
KARNATAKA
586103
India |
| Phone |
|
| Fax |
|
| Email |
sahasankalpa88@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dayand Talikoti |
| Designation |
Professor |
| Affiliation |
BLDE (DU) UNIVERSITY |
| Address |
Department of anesthesia, Shri BM Patil Medical College, BLDE Univ, Vijayapura
Bijapur
KARNATAKA
586103
India |
| Phone |
|
| Fax |
|
| Email |
dayandtalikoti@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sankalpa Saha |
| Designation |
Junior Resident |
| Affiliation |
BLDE (DU) UNIVERSITY |
| Address |
Department of anesthesia, Shri BM Patil Medical College, BLDE Univ, Vijayapura
Bijapur
KARNATAKA
586103
India |
| Phone |
|
| Fax |
|
| Email |
sahasankalpa88@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri BM Patil Medical College BLDE DU Vijayapura Karnataka 586103 |
|
|
Primary Sponsor
|
| Name |
Shri BM Patil Medical College |
| Address |
Blde Deemed To Be University Shri Bm Patil Medical College Hospital And Research Centre Blde (Deemed To Be University), Smt. Bagaramma Sajjan Campus, Dr B M Patil Road (Solapur Road) Vijayapura(Bijapur)-586103, Karnataka, India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Sankalpa Saha |
BLDE(DU) Shri BM Patil Medical College |
Room no 5, OT complex , Department of Anaesthesiology ,Solapur Road, Vijayapura Bijapur KARNATAKA
Bijapur
KARNATAKA
Bijapur
KARNATAKA |
8420359233
sahasankalpa88@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE |
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 |
| Intervention |
Administering spinal anesthesia using ultrasound guided paramedian technique vs conventional landmark guided paramedian technique |
Total 80 patients will be selected by randomisation technique alternatively as group LM and group USG. Group LM will be given spinal anesthesia using conventional landmark guided technique versus Group USG who will be administered Using Ultrasound. In both the groups the spinal anaesthesia is given via a Paramedian approach. We compare the number of needle passes and needle insertion attempts in both the groups. |
| Comparator Agent |
Type of technique of spinal anesthesia |
ultrasound guided paramedian technique vs conventional landmark guided paramedian technique |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. All consenting patients planned for elective lower abdomen, pelvic and lower limb surgeries under spinal anaesthesia
2. Age 50 years and above
3. ASA grade I and II
|
|
| ExclusionCriteria |
| Details |
1. Patients with known allergy to local anaesthetic drug
2. Patients with coagulopathies
3. Signs of infection at site of injection
4. Patients with previous spinal surgeries
5. Patient refusal
6. Neurological disorder or deficit
|
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To compare number of needle passes in both groups (i.e. withdrawal and redirection of spinal needle without exiting the skin)
2. To compare number of needle attempts in both groups (i.e. number of times the spinal needle was withdrawn from skin and reinserted) |
At 10, 20 and 30 minutes after Spinal Anaesthesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare incidence of blood in spinal needle in both groups |
Immediately after the procedure |
|
|
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)
|
30/06/2021 |
| 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
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
To study the efficacy and safety of pre-procedure ultrasound guided paramedian technique as compared to conventional landmark guided paramedian technique in administering spinal anesthesia |