| CTRI Number |
CTRI/2024/12/078678 [Registered on: 27/12/2024] Trial Registered Prospectively |
| Last Modified On: |
11/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Safety of Segmental Spinal Anaesthesia for Caesarean Section |
|
Scientific Title of Study
|
Evaluation of Materno-fetal Safety Profile under Segmental Spinal Anesthesia for Elective Lower Segment Caesarean Section: An Observational Cohort Study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ruma Thakuria |
| Designation |
Assistant professor |
| Affiliation |
All India Institute of Medical Sciences, Rishikesh |
| Address |
Department of Anaesthesiology,6th floor
All India Institute of Medical Sciences Rishikesh
Dehradun UTTARANCHAL 249203 India |
| Phone |
7838689025 |
| Fax |
|
| Email |
rumathakuria123@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Ruma Thakuria |
| Designation |
Assistant professor |
| Affiliation |
All India Institute of Medical Sciences, Rishikesh |
| Address |
Department of Anaesthesiology,6th floor
All India Institute of Medical Sciences Rishikesh
Dehradun UTTARANCHAL 249203 India |
| Phone |
7838689025 |
| Fax |
|
| Email |
rumathakuria123@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Ruma Thakuria |
| Designation |
Assistant professor |
| Affiliation |
All India Institute of Medical Sciences, Rishikesh |
| Address |
Department of Anaesthesiology,6th floor
All India Institute of Medical Sciences Rishikesh
Dehradun UTTARANCHAL 249203 India |
| Phone |
7838689025 |
| Fax |
|
| Email |
rumathakuria123@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology
Level 6
Medical College Building
All India Institute of Medical Sciences Rishikesh
Virbhadra Marg
Pashulok
India
PIN 249203
|
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Rishikesh |
| Address |
Department of Anaesthesiology Level 6
Room no 016126
AIIMS Rishikesh
Pin code 249203
Uttarakhand |
| 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 Ruma Thakuria |
AIIMS Rishikesh |
Department of Anaesthesiology
All India Institute of Medicakl Sciences Rishikesh-249203 Dehradun UTTARANCHAL |
7838689025
rumathakuria123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute ethics committee AIIMS Rishikesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O82||Encounter for cesarean delivery without indication, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Lumbar Spinal Anaesthesia |
Spinal Anaesthesia would be administered at Lumbar level L3-L4 or L4-L5 interspace with Local anaesthetic and fentanyl |
| Comparator Agent |
Thoracic Spinal Anaesthesia |
Spinal Anaesthesia would be given in the thoracic level, T10-T11 interspace with local anaesthetic and fentanyl |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1.Singleton term pregnancy undergoing elective LSCS under two different segmental spinal anaesthesia techniques (lower thoracic & lumbar)
2.Age between 18-40 years
3.American Society of Anaesthesiology physical grade (ASA) I and II
|
|
| ExclusionCriteria |
| Details |
1.Parturient undergoing LSCS under any other modality of anaesthesia (General anaesthesia, any other segmental spinal anaesthesia).
2.Body Mass Index more than 35
3.Any major comorbid medical conditions,major end-organ dysfunction
4.Conditions that may interfere with patient ability to reciprocate study outcome
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Association of segmental spinal blockade to intraoperative materno-foetal outcome (cardiorespiratory and APGAR score) in parturient undergoing elective LSCS under spinal anesthesia at different block levels |
During intraoperative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Association of segmental spinal blockade to postoperative (24 hrs) materno-foetal outcome (cardiorespiratory) in parturient undergoing elective LSCS under spinal anesthesia at different block levels
2.Association of segmental spinal blockade to intraoperative Umbilical arterial blood gas parameters in parturient undergoing elective LSCS
3.To evaluate block characteristics of segmental spinal anaesthesia in parturients undergoing elective LSCS
4.Evaluation of Maternal satisfaction and obstetric recovery score (at 24 hours postoperatively) with respect-to-block characteristics in segmental spinal anaesthesia for parturients undergoing elective LSCS
5.Any other materno-foetal complications during the study duration (24 hr postoperatively)
|
During intraoperative and postoperative period upto 24 hours |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
01/01/2025 |
| 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="3" Months="0" 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
|
| Central neuraxial anaesthesia is now preferred in over 80-95% of parturients undergoing LSCS. Lumbar segmental spinal anaesthesia (LSSA) is a simpler and easy procedure with a relatively rapid onset of the dense neuraxial blockade and avoids the need for maternal endotracheal intubation, which is a difficult procedure during pregnancy due to upper airway changes. However traditional lumbar segmental spinal anaesthesia causes extensive sympathectomy (thoracic-lumbar-sacral output, T4-S5 segments) and hypotension, which may affect uterine circulation and possibly affect the foetus. Further motor paralysis of lower limbs due to blockade of lumbar segmental spinal nerve roots results in delay in ambulation and early recovery of parturient obstructing the mother from participating in the care of their own newborn babies in the immediate post-natal period which is required for the bonding of mother & neonate. Thoracic segmental spinal anaesthesia has also been used for LSCS in high-risk obstetric patients (severe pregnancy-induced hypertension) where traditional lumbar spinal anaesthesia was contraindicated. The present study would be observational study of maternal and fetal outcomes of elective LSCS conducted under different segmental spinal anesthesia in our institute. The study would note/observe maternal (cardio-respiratory) and foetal (APGAR score and cord blood gas parameters) outcomes with regards to safety of thoracic segmental spinal anaesthesia and compare it with the outcomes of lumbar segmental spinal anesthesia. | |