| CTRI Number |
CTRI/2020/02/023089 [Registered on: 03/02/2020] Trial Registered Prospectively |
| Last Modified On: |
07/02/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Use of Ultrasonogram Technique in Spinal Anesthesia for Cesaerean Surgery in Pregnancy |
|
Scientific Title of Study
|
USG Guided Subarachnoid Block for Caesarean Section in Labouring Parturition |
| Trial Acronym |
USGL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr C K Swetha Ramani |
| Designation |
Assistant Professor |
| Affiliation |
SRM Medical College and Research Institute |
| Address |
3083 Estancia Vallanchery Guduvanchery Kancheepuram
SRM Medical College and Research Institute Potheri Kancheepuram
Kancheepuram
TAMIL NADU
603202
India |
| Phone |
9884782554 |
| Fax |
|
| Email |
swemohan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr C K Swetha Ramani |
| Designation |
Assistant Professor |
| Affiliation |
SRM Medical College and Research Institute |
| Address |
3083 Estancia Vallanchery Guduvanchery Kancheepuram
SRM Medical College and Research Institute Potheri Kancheepuram
Kancheepuram
TAMIL NADU
603202
India |
| Phone |
9884782554 |
| Fax |
|
| Email |
swemohan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr C K Swetha Ramani |
| Designation |
Assistant Professor |
| Affiliation |
SRM Medical College and Research Institute |
| Address |
3083 Estancia Vallanchery Guduvanchery Kancheepuram
SRM Medical College and Research Institute Potheri Kancheepuram
Kancheepuram
TAMIL NADU
603202
India |
| Phone |
9884782554 |
| Fax |
|
| Email |
swemohan@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRM Medical College and Research Institute |
|
|
Primary Sponsor
|
| Name |
SRM Medical College and Research Institute |
| Address |
Potheri Chengelpattu 603211 Tamilnadu India |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr C K Swetha Ramani |
3083 Estancia Vallanchery Guduvanchery Kancheepuram |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr C K Swetha Ramani |
SRM MEDICAL COLLEGE & RESEARCH CENTRE |
SRM MCH & RC, SRM Nagar Potheri Kattankulathur 603203 Kancheepuram District Tamilnadu India
Kancheepuram
TAMIL NADU |
9884782554
2745106
swemohan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee SRM Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Pregnant Parturient |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Ultrasound guided method |
Comparison of time taken for Ultrasound Guided method and Landmark Technique for Subarachnoid Technique for Caesarean Section |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Elective Cesarean Surgeries
ASA II
BMI 24 to 30
|
|
| ExclusionCriteria |
| Details |
Emergency Cesearean Section
Infection at the site of injection
Patient refusal
Coagulopathy or other bleeding diathesis
Severe hypovolemia
Increased intracranial pressure
Severe aortic stenosis
Severe mitral stenosis
Sepsis
Uncooperative patient
Preexisting neurological deficits
Demyelinating lesions
Stenotic valvular heart lesions
Left ventricular outflow obstruction (hypertrophic obstructive cardiomyopathy
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the time taken (in seconds) for Subarachnoid Block between the USG guided Technique and the Landmark Technique |
The time (in seconds) from when the spinal needle is inserted in the interspinous space till the CSF drop in the spinal needle |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Number of attempts : same space and different space
Number of redirections
Failure of subarachnoid block
Conversion to General Anaesthesia
Measurement of distance from skin to Posterior Complex
Total preparation time
Patient satisfaction |
6 months
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
02/09/2019 |
| 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="0"
Months="6"
Days="20" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
National Journals |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The purpose of our study is to compare the time taken for subarachnoid block administered by traditional Landmark Technique versus Ultrasound Guided Subarachnoid Block in Caesarean section, in terms of time taken, number of attempts, number of redirections and number of failure of subarachnoid block, total preparation time, conversion to General anaesthesia and patient satisfaction.30 parturients scheduled to undergo elective caesarean section under spinal anaesthesia were included in the study.Group allocation was done by a closed envelope technique. In Group I,30 patients will receive Spinal anaesthesia by landmark technique and in Group II, 30 patients will undergo Ultrasound guided Spinal.
|