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CTRI Number  CTRI/2025/07/090373 [Registered on: 07/07/2025] Trial Registered Prospectively
Last Modified On: 07/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Prospective randomised observational study 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing two ways of recovering after a planned C-section : Enhanced Recovery Protocol vs. Traditional Approach. 
Scientific Title of Study   Comparison of Enhanced Recovery After Cesarean protocol versus Traditional approach in elective lower segment cesarean section under spinal anaesthesia : A Prospective Observational Study. 
Trial Acronym 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Arushi Johri 
Designation  PG Resident 2nd Year 
Affiliation  Mahatma Gandhi Medical College and Hospital 
Address  2nd Floor OT Complex Department of Anaesthesiology at Mahatma Gandhi Medical College and Hospital Sitapura Jaipur

Jaipur
RAJASTHAN
302022
India 
Phone  8700686941  
Fax    
Email  arushi.johri@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Kalpana Verma 
Designation  Professor 
Affiliation  Mahatma Gandhi Medical College and Hospital 
Address  2nd Floor OT Complex OT No 7 Department of Anaesthesiology at Mahatma Gandhi Medical College and Hospital Sitapura Jaipur

Jaipur
RAJASTHAN
302022
India 
Phone  7727886029  
Fax    
Email  kalpana2007.kv@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Arushi Johri 
Designation  PG Resident 2nd Year 
Affiliation  Mahatma Gandhi Medical College and Hospital 
Address  2nd Floor OT Complex Department of Anaesthesiology at Mahatma Gandhi Medical College and Hospital Sitapura Jaipur

Jaipur
RAJASTHAN
302022
India 
Phone  8700686941  
Fax    
Email  arushi.johri@gmail.com  
 
Source of Monetary or Material Support  
Mahatma Gandhi Hospital Jaipur 
 
Primary Sponsor  
Name  Mahatma Gandhi Medical College and Hospital 
Address  Department of Anaesthesiology Mahatma Gandhi Medical College and Hospital Sitapura Jaipur 
Type of Sponsor  Private 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 
Dr Arushi Johri  Mahatma Gandhi Medical College and Hospital  Department of Anaesthesiology OT Complex Second Floor Main Hospital Building Jaipur Rajasthan
Jaipur
RAJASTHAN 
8700686941

arushi.johri@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Mahatma Gandhi Medical College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 1||Obstetrics,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Comparator Agent  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  1. Patients scheduled for elective caesarean sections.
2. Age between 18 to 45 years.
3. American Society of Anaesthesiology grade I - II. 
 
ExclusionCriteria 
Details  1. Psychiatric/neurological illness, or coagulopathy.
2. Patients with Rh negative pregnancy, presence of any medical disorders during pregnancy and abnormal placentation.
3. Known allergy.
4. Individuals who underwent failed spinal anaesthesia and required conversion to general anaesthesia. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Comparison of total duration of stay (readiness to discharge) in the hospital between Enhanced Recovery After Caesarean Protocol and Traditional Approach  1. Pre-operative Examination.
2. Intra-operative Examination.
3. Post-operative variables. 
 
Secondary Outcome  
Outcome  TimePoints 
Comparison of VAS Scores and requirement of Analgesics in 24 hours.  0 hours, 2nd hour, 4th hour, 8th hour, 12th hour, 16th hour, 24th hour. 
Assessment of urinary retention and need of re-catheterisation.  Post-operatively. 
Assessment of adverse events like nausea, vomiting, shivering and respiratory depression.  Intra-operatively and Post-operatively. 
 
Target Sample Size   Total Sample Size="172"
Sample Size from India="172" 
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)   30/07/2025 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  
It is a hospital based prospective randomised observational study to be conducted by the Department Of Anaesthesiology, Mahatma Gandhi Medical College & Hospital.

The initiation of this study is contingent upon obtaining ethical clearance from the Institutional Ethics Committee (IEC). Comprehensive written and informed consent will be diligently obtained from all participating patients.

The sample size was estimated by using the formula for comparison of two independent mean. Anticipating a medium effect size of 0.5 in the day of readiness for discharge between the two groups, the minimum sample size required is 172 i.e., 86 in each group at 5 % level of significance and 90% power.

A multi disciplinary team comprising anaesthesiologists, obstetricians, neonatologists, and nursing professional, will gather to discuss the change in peri partum management of patient undergoing elective cesarean section. After going through various guidelines proposed by Society of Obstetric Anaesthesia and Perinatology, American College of Obstetrics and Gynaecology, and ERAC society and extensive discussion, strategies for standardization of care was decided. Broadly major components, which will be key to improved outcome according to previous research and found feasible to implement in our hospital will be included in the revised ERAC protocol.

Parturients undergoing traditional protocol will continue the routine practice of admission a day prior to surgery, with scheduled preoperative counselling, overnight fasting, and liberal fluid administration along with use of povidone iodine as a standard antiseptic for all aseptic procedures. Standard practice of day 2 mobilization and delayed catheter removal will be continued for them. In the ERAC protocol, parturients will be counselled in detail on antenatal visit about risks and complications associated with the procedure and will  also be sensitized about the ERAC program and its benefits. After thorough understanding of the ERAC components and approval, parturients will be asked to get admitted a day prior to surgery or on the day of surgery with advice to be followed at home for prior day. Alcohol based chlorhexidine solution will be used for asepsis except for vaginal toileting.

Pre-operative fasting will be reduced to 2 hrs for clear liquids and carbohydrate rich drinks will be given a night before and on the day of surgery to avoid hypoglycaemia. Neuraxial anaesthesia  (Sub-arachnoid Block; SAB) will be administered in both the protocols. In ERAC Protocol, USG guided Transversus Abdominis Plane block will be given for post-operative pain relief. In ERAC protocol, patients will receive fluid administration @15–20 ml/hr  and early feeding (within 2 hrs sips of water) early mobilization and de-catheterization within 6–10 hrs with multimodal analgesia to cover postoperative pain.
 
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