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CTRI Number  CTRI/2021/11/037933 [Registered on: 10/11/2021] Trial Registered Prospectively
Last Modified On: 16/11/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of two positions (lateral and sitting ) for achievement of block of hight in spinal anaesthesia in caesarian section 
Scientific Title of Study   "comparision of time to achieve t5 blockade in left lateral versus sitting position during caesarean section under spinal anaesthesia: a prospective randomized single bind study"  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sarita kumawat 
Designation  Resident 
Affiliation  RNT medical College  
Address  Department of Anesthesiology MB Govt hospital

Udaipur
RAJASTHAN
313001
India 
Phone  09166688741  
Fax    
Email  saritasureshh13@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Devendra verma 
Designation  Senior Professor 
Affiliation  RNT Medical College  
Address  Department of Anesthesiology MB Govt hospital Udaipur

Udaipur
RAJASTHAN
313001
India 
Phone  9414289538  
Fax    
Email  devendra.anaes@yahoo.in  
 
Details of Contact Person
Public Query  
Name  Sarita kumawat 
Designation  Resident 
Affiliation  RNT Medical College 
Address  Department of Anesthesiology MB Govt hospital udaipur

Udaipur
RAJASTHAN
313001
India 
Phone  09166688741  
Fax    
Email  saritasureshh13@gmail.com  
 
Source of Monetary or Material Support  
No Monetary/Material Support  
 
Primary Sponsor  
Name  RNT Medical College and MB hospital Udaipur 
Address  RNT Medical College and MB hospital Udaipur 
Type of Sponsor  Government medical college 
 
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 
Sarita kumawat  PANNA DHAYA GOVT HOSPITAL  Zanana operation theater first floor
Udaipur
RAJASTHAN 		 09166688741

saritasureshh13@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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O80||Encounter for full-term uncomplicated delivery, (2) ICD-10 Condition: O80||Encounter for full-term uncomplicated delivery, (3) ICD-10 Condition: 1||Obstetrics,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Spinal anaesthesia in Sitting position   Parturients will receive spinal anaesthesia in sitting position. 
Comparator Agent  Spinal anaesthesia in Lateral position  Parturients will receive spinal anaesthesia in lateral position.  
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  This study will be carried out in pregnant patients with single term pregnancy, taken up for Caesarean Section under spinal anaesthesia for various indications like previous Caesarean Section, breech presentation, cephalopelvic disproportion, pregnancy following infertility treatment, cord around neck, non-progression of labour. 
 
ExclusionCriteria 
Details  Patient refusal to participate in study.
Emergency indication of Caesarean Section like antepartum haemorrhage, Placenta previa, abruptio placenta, foetal distress, obstructed labour, umbilical cord prolapse, preeclampsia, gestational diabetes, essential hypertension, more than two previous LSCS, history of PPH, multiple gestation.
Patients having contraindication for subarachnoid block.
Patient having associated systemic illness (hypo/hyperthyroidism, diabetic, neuromuscular disease ischaemic/ valvular/ congenital heart disease, psychiatric, haematological disorder, SLE).
History of seizures, coma, neurological signs or symptoms (Eclampsia).
Any allergy to local anaesthetic or any drug.
Parturient with extremes of height (<150 or >170cm), with extremes of weight (BMI <20 kg/m2 or > 35kg/m2. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Time to achieve T5 blockage in both group.
 		 Upto 15 min after spinal anaesthesia
 
 
Secondary Outcome  
Outcome  TimePoints 
assess the adverse effect / haemodynamic disturbances, if any.
 		 intra-operative as well as post operative up to 24 hours 
 
Target Sample Size   Total Sample Size="204"
Sample Size from India="204" 
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)
Modification(s)  		 20/11/2021 
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="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   This research is being conducted as dissertation 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   The number of caesarean sections performed has increased tremendously in the recent year. Spinal anaesthesia is preferred anaesthetic technique followed as to avoid problems with general anaesthesia such as manipulation of airway, aspiration, cognitive dysfunction, and the use of polypharmacy. Regional anaesthesia is the most popular form of anaesthesia for caesarean section due to avoiding risks of general anaesthesia, for better postoperative pain relief and also for keeping the woman awake to see her baby just after birth.
AIMS AND OBJECTIVES
To compare the time to achieve T5 blockage in lateral versus sitting position during elective caesarean section under spinal anaesthesia Study design: A prospective, single-blind, randomized, observational, study..
 
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