| CTRI Number |
CTRI/2024/01/061409 [Registered on: 12/01/2024] Trial Registered Prospectively |
| Last Modified On: |
11/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare anaesthesia block produced with the patient lying in two different positions after receiving local anaesthetic injection in the spine for caesarean delivery |
|
Scientific Title of Study
|
Comparative evaluation of block characteristics in the supine knee-chest position and supine position in parturients undergoing elective caesarean delivery under spinal anaesthesia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anmoldeep Kaur Sran |
| Designation |
Postgraduate student |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive Care
Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi
South DELHI 110029 India |
| Phone |
8427355499 |
| Fax |
|
| Email |
Anmolkaur15499@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Smita Prakash |
| Designation |
Professor |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive Care
Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi South DELHI 110029 India |
| Phone |
9810347125 |
| Fax |
|
| Email |
drsunilprakash@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Smita Prakash |
| Designation |
Professor |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive Care
Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi
DELHI 110029 India |
| Phone |
9810347125 |
| Fax |
|
| Email |
drsunilprakash@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi |
|
|
Primary Sponsor
|
| Name |
Safdarjung Hospital |
| Address |
Vardhman Mahavir Medical College and Safdarjung Hospital, 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 Smita Prakash |
Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi |
Maternity Operation
Theatre,
Department of
Anaesthesia and
Intensive Care,
Vardhman Mahavir
Medical College and
Safdarjung Hospital,
New Delhi South DELHI |
9810347125
drsunilprakash@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: O||Medical and Surgical, (2) ICD-10 Condition: 1||Obstetrics, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Supine knee-chest position |
One minute duration |
| Comparator Agent |
Supine position |
One minute duration |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
American Society of Anesthesiologists physical status II women, with singleton term pregnancy, undergoing elective caesarean delivery under spinal anaesthesia. |
|
| ExclusionCriteria |
| Details |
1. Weight less than 50 kg or more than 100 kg, height < 140 cm and > 170 cm
2. Known allergy to any study medication or any contraindication to spinal anaesthesia
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Onset time of sensory block (measured from intrathecal drug administration till achievement of T6 block height) between supine knee-chest position and supine position in parturients undergoing caesarean delivery |
Every 2 min after administration of spinal anaesthesia until there is no further rise in the block level for 4 minutes and at 5 minutes thereafter. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Maximum sensory block height and motor block
2.Incidence of hypotension and bradycardia and requirement of fluid and vasopressor
3.Neonatal APGAR score at 1 min and 5 min
|
Every 2 min after administration of spinal anaesthesia until there is no further rise in the block level for 4 minutes and at 5 minutes thereafter. |
|
|
Target Sample Size
|
Total Sample Size="33" Sample Size from India="33"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
31/01/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 pregnant women with category 1 indication for caesarean delivery (immediate threat to life of parturient or foetus) rapid delivery of foetus is necessary. Such patients often receive general anaesthesia, as it is a time saving and a more reliable option compared to the spinal block. There is evidence that the onset of adequate surgical anaesthesia for caesarean delivery can be hastened by placing the patient in the knee-chest position for a minute immediately after performing the spinal anaesthesia in the sitting position. The haemodynamic effect of this technique was safe in the patient population. There is paucity of literature that compares spinal block characteristics between supine knee-chest and supine positions in parturients undergoing caesarean delivery under spinal anaesthesia. The study hypothesis is that the supine knee-chest position shortens the onset time of sensory block compared with the supine position in parturients undergoing elective caesarean delivery under spinal anaesthesia. Therefore, we are conducting this study to assess the spinal block characteristics between supine knee-chest position and supine position in parturients undergoing elective caesarean delivery. |