| 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
|
|
|
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
|
|
|
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. |