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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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