| CTRI Number |
CTRI/2023/02/049782 [Registered on: 16/02/2023] Trial Registered Prospectively |
| Last Modified On: |
03/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparision between ERAC (Enhanced Recovery after ceaserean section)Criteria and Traditional method of Recovery |
|
Scientific Title of Study
|
Enhanced Recovery after C-Section versus Traditional Protocol in Elective C Section |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aditya Singh |
| Designation |
Resident Doctor |
| Affiliation |
PDU MEDICAL COLLEGE RAJKOT |
| Address |
Department of Anesthesiology,3rd floor OPD Building,PDU Medical College, Rajkot, Gujarat
Department of Anesthesiology,3rd floor OPD Building,PDU Medical College, Rajkot, Gujarat
Rajkot
GUJARAT
360001
India |
| Phone |
09755388711 |
| Fax |
02812458340 |
| Email |
timmydbz@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Khyati Jethva |
| Designation |
Assistant Professor |
| Affiliation |
PDU MEDICAL COLLEGE RAJKOT |
| Address |
Department of Anesthesiology,3rd floor OPD Building,PDU Medical College, Rajkot, Gujarat
Department of Anesthesiology,3rd floor OPD Building,PDU Medical College, Rajkot, Gujarat
Rajkot
GUJARAT
360001
India |
| Phone |
9913732613 |
| Fax |
02812458340 |
| Email |
khyatijethva13@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aditya Singh |
| Designation |
Resident Doctor |
| Affiliation |
PDU MEDICAL COLLEGE RAJKOT |
| Address |
Department of Anesthesiology,3rd floor OPD Building,PDU Medical College, Rajkot, Gujarat
Department of Anesthesiology,3rd floor OPD Building,PDU Medical College, Rajkot, Gujarat
Rajkot
GUJARAT
360001
India |
| Phone |
09755388711 |
| Fax |
02812458340 |
| Email |
timmydbz@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology, PDU Medical College,Civil Hospital Campus,Rajkot, Gujarat |
|
|
Primary Sponsor
|
| Name |
Aditya Singh |
| Address |
Department of Anesthesiology,PDU MEDICAL COLLEGE RAJKOT GUJARAT |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Aditya Singh |
PDU MEDICAL COLLEGE AND CIVIL HOSPITAL |
3rd floor, OPD building, Department of Anesthesiology
Rajkot
GUJARAT |
9755388711
02812458340
timmydbz@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical Committee,PDU MEDICAL COLLEGE RAJKOT GUJARAT INDIA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Pregnant Females |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Enhanced recovery after C Section in Elective C section |
In this trial comparision of efficacy of Traditional method of recovery after Elective C section |
| Intervention |
ENHANCED RECOVERY AFTER C-SECTION in Elective C-Section |
In this trial there is a comparison of the efficacy of implementation of predefined ERAC criteria in patients of elective C Section. |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
25 to 40 years women having gestation age more than 38 weeks posted for elective caesearean section will be included in the study. |
|
| ExclusionCriteria |
| Details |
Prior medical illness like anemia, cardiac ,renal , thyroid diseases, hypertensive disorder of pregnancy, gestational diabetes, intra and post postpartum heamorrage ,bladder injury and bowel injury will be excluded from the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Our primary outcome is to asses Patient satisfaction and
Readiness of discharge in postoperative period |
Our primary outcome is to assess
1) The readiness of discharge in 3rd,5th and 7th postoperative day
2) Patient satisfaction upto 24hours postoperative in postoperative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Our secondary outcome is to asses 1)Post operative pain assessment
2)Requirement of post operative analgesia
3)Early oral intake and Mobilization
4)Postoperative nausea and vomiting
5)Optimization of intraoperative vasopressors and uterotonics
|
Our secondary outcome is
1)To asses and note the time of postoperative Pain in 2hour 4hour 6 hourafter operative
2)Nausea and vomiting in 2 hour 4 hour and 6 hour after operation
3) Mobilization 4hour 8hour 12 hour and 24 hour after operation
3)oral intake after 4hour6hour and 8hour after operation
|
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
21/02/2023 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
• Enhanced recovery after cesarean provides an evidenced based system to improve maternal based outcomes ,fuctional recovery,maternal infant bonding,and patient experience.ERAC involves multidisciplinary team efforts of anesthesiologists,obstetrician,nursing staff,hospital and patient. • ERAC is best conceptualized as a continuum of care ,from preconception outreach,antepartum optimization,intrapartum care, which includes the anesthetic management and concluding with postpartum inpatient care and outpatient support . • Enhanced recovery was first described by in 1997 by wilmore and kehlet.The concept was first introduced in colorectal surgeries and now practiced across all specialities • There is wide variation in the components of enhanced recovery after surgery among different specialities but the principle remain same. The various components of Enhanced recovery includes provision of preadmission, information to expectant mothers ,Good perioperative nutrition and hydration ,minimally invasive surgical technique, efforts to maintain normothermia ,prevention of postoperative nausea and voimiting, effective peri- operative pain relief, early post operative oral intake, removal of urinary cathter,readiness to discharge and postoperative mobilization.
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