| CTRI Number |
CTRI/2024/07/070581 [Registered on: 15/07/2024] Trial Registered Prospectively |
| Last Modified On: |
13/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative study of lateral and sitting positions for time to achieve T5 sensory blockade after spinal anaesthesia in labouring parturients undergoing carsarean section |
|
Scientific Title of Study
|
Comparison of lateral and sitting positions for time to achieve T5 sensory blockade after spinal anaesthesia in labouring parturients undergoing caesarean section |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ranju Gandhi |
| Designation |
Consultant and professor |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive care, VMMC and Safdarjung Hospital, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9818941341 |
| Fax |
|
| Email |
icu_era@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Ranju Gandhi |
| Designation |
Consultant and professor |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive care, VMMC and Safdarjung Hospital, New Delhi
DELHI
110029
India |
| Phone |
9818941341 |
| Fax |
|
| Email |
icu_era@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Ranju Gandhi |
| Designation |
Consultant and professor |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive care, VMMC and Safdarjung Hospital, New Delhi
DELHI
110029
India |
| Phone |
9818941341 |
| Fax |
|
| Email |
icu_era@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Vardhman Mahavir Medical College |
| Address |
Safdarjung Hospital Ansari Nagar New Delhi 110029 |
| Type of Sponsor |
Government 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 Sarita Rao |
Safdarjung Hospital and Vardhman Mahavir Medical College, New Delhi, Delhi India |
Department of Anaesthesia and Intensive care, Ground floor, Main OT complex, Safdarjung Hospital and Vardhman Mahavir Medical College, New Delhi 110029, India, New Delhi
South
DELHI |
7042352624
raosarita111@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Spinal anaesthesia given in lateral position. |
In lateral group, administration of drug into the subarachnoid space will be done in lateral position and time taken to achive T5 sensory blockade will be noted and maximal level of sensory block will be defined as number of spinal segments blocked above T5 at 60 minutes after administration of drug into subarachnoid space. |
| Intervention |
Spinal anaesthesia given in sitting position. |
In sitting group, administration of drug into the subarachnoid space will be done in sitting position and time taken to achieve T5 sensory blockade will be noted and maximal level of sensory block will be defined as number of spinal segments blocked above T5 at 60 minutes after administration of drug into subarachnoid space. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Labouring parturients with age between 18-40 years with ASA physical status 2 undergoing caesarean section under spinal anaesthesia |
|
| ExclusionCriteria |
| Details |
1. Spine pathology
2. Coagulation abnormality or bleeding diathesis
3. Local infection at the site of spinal anaesthesia
4. Hypersensitivity to local anaesthetic drug
5. Obese parturient |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the lateral & sitting positions for time to achieve T5 sensory blockade after spinal anaesthesia in labouring parturients undergoing caesarean section |
To compare the number of spinal segments blocked above T5 dermatomal level in 60 minutes after administration of drug into subarachnoid space in labouring parturients undergoing caesarean section in sitting and lateral position. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the lateral & sitting positions for the block characteristics time taken to achieve motor block Modified Bromage Score 3
maximum sensory block height duration of motor & sensory blockade in labouring parturients undergoing caesarean section with spinal anaesthesia
To compare intraoperative haemodynamics HR SBP DBP MAP in the two groups
|
Intraoperative time |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
24/07/2024 |
| 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
|
Spinal anaesthesia is a safe and widely used technique in caesarean section as it avoids problems with general anaesthesia such as manipulation of airway, aspiration, cognitive dysfunction and the use of polypharmacy. |