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CTRI Number  CTRI/2024/04/065365 [Registered on: 08/04/2024] Trial Registered Prospectively
Last Modified On: 06/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Decreasing the duration of stay in hospital after caesarean delivery by using early discharge guidelines. 
Scientific Title of Study   Comparing the enhanced recovery after caesarean delivery with conventional care in maternal outcome: A randomised controlled 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 Ramesh Koppal 
Designation  Professor 
Affiliation  S NIjalingappa Medical college 
Address  Department of Anaesthesiology, S.N.M.C and HSK hospital , Navanagar,Bagalkot

Bagalkot
KARNATAKA
587102
India 
Phone  9845504515  
Fax    
Email  rameshkoppaldr@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ramesh Koppal 
Designation  Professor 
Affiliation  S NIjalingappa Medical college 
Address  Department of Anaesthesiology, S.N.M.C and HSK hospital , Navanagar,Bagalkot

Bagalkot
KARNATAKA
587102
India 
Phone  9845504515  
Fax    
Email  rameshkoppaldr@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Harshitha G 
Designation  Junior Resident 
Affiliation  S NIjalingappa Medical college 
Address  Department of Anaesthesiology, S.N.M.C and HSK hospital , Navanagar,Bagalkot

Bagalkot
KARNATAKA
587102
India 
Phone  9035490874  
Fax    
Email  harshithag4@gmail.com  
 
Source of Monetary or Material Support  
Full term pregnant women coming to S N Medical college and HSK hospital posted for elective caesarean delivery under spinal anaesthesia.  
 
Primary Sponsor  
Name  S Nijalingappa medical college 
Address  Department of Anaesthesiology, Second floor, S.N.M.C and HSK hospital , Navanagar,Bagalkot , Karnataka  
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 Ramesh Koppal  HSK hospital, S Nijalingappa Medical College  Obstetrics and Gynaecology OT complex, Ground floor, S.N.M.C and HSK hospital , Navanagar,Bagalkot , Karnataka PIN-587 102.
Bagalkot
KARNATAKA 
9845504515

rameshkoppaldr@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
S Nijalingappa Medival College And Hanagal Shri Kumareshwar Hospital And Research Centre  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  PREGNANCY 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Caesarean delivery-Conventional care  PRE-OP-NBM more than 8 hours, patient may be counselled, IV fluids may be started, antibiotics may be given. INTRA-OP: No prophylactic vasopressors, liberal IV fluids, no mother to baby contact or breast feeding. POST-OP: delayed catheter removal, oral intake and ambulation, discharge after 5 days. Conventional analgesic care.  
Comparator Agent  ERAC  PRE_OP-Clear liquids around 600ml given 2 hours prior, patient will be counselled in a better way, Saline lock, 1 hour prior antibiotic. INTRA-OP-Prophylactic vasopressor, controlled IV fluids, Baby-Mother contact and breast feeding immediately after extraction of the baby. POST-OP-Multimodal analgesia, early catheter removal and ambulation and early oral intake, discharge on 3rd day 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  1] Age group :21-45 years women having gestational age more than 37 weeks
2] Elective caesarean deliveries done under Spinal Anaesthesia
3] ASA (American Society Of Anaesthesiologists) physical status II
 
 
ExclusionCriteria 
Details  1] Refusal to Enroll for the study
2] Any contraindications for spinal anaesthesia
3] Multiple gestation
4] Hypertensive disorders of pregnancy
5] Uncontrolled diabetes mellitus
6] Obesity BMI more than 40kg/m2
7] Other obstetric complications during surgery like post-partum hemorrhage, bladder injury, bowel injury [will be excluded from the study]
8] Any other medical illness like anemia, cardiac diseases, renal diseases
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Decreased length of stay and early discharge.   72 hours 
 
Secondary Outcome  
Outcome  TimePoints 
Better maternal satisfaction and maternal bonding with the baby. It also helps in decreasing the burden on maternal socioeconomic status and health care system.   72 hours 
 
Target Sample Size   Total Sample Size="140"
Sample Size from India="140" 
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   Phase 2/ Phase 3 
Date of First Enrollment (India)   17/04/2024 
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  

Enhanced recovery after caesarean delivery (ERAC) is a comprehensive multidisciplinary protocol based with well-defined perioperative interventions with inclusion of anesthesiologists, obstetricians, pediatricians, nurses, patients, and hospital administration. The activity of ERAC begins from the time of preoperative assessment and extends into the postoperative period with the threefold aim of providing best quality of care, cutting down cost and improving patient satisfaction level.

The aim of this study is to implement predefined ERAC protocol for the better management of elective caesarean section patients and its comparison with existing traditional protocol to evaluate the barriers in its implementation, to provide better quality of care and reduce financial burden.

PRE-OPERATIVE PERIOD

In conventional care, pre-operatively the pregnant women is counselled about the procedure and explained about the nil per oral of 8hrs for both solid and liquid. Antibiotics may not be strictly given and intravenous fluids maybe started prior to surgery.

 In ERAC pre-operatively the pregnant women will be counselled about the procedure and explained about the nil per oral of 8 hours for solids and 2 hours prior to surgery, clear liquids of around 600ml will be given to the pregnant women. [clear liquids-pulp free juice, coconut water , electrolyte solution, tea/coffee without milk] Saline lock  i.e no intravenous fluids are given to the pregnant women preoperatively.[7] Intravenous antibiotic Inj Ceftriaxone 1g will be given 60 minutes prior to the surgery.

 INTRA-OPERATIVE PERIOD

In conventional care, during intraoperative period the room temp is not controlled. The pregnant woman is shifted to operation theatre with secured and patent 18G IV cannula, all ASA standard monitors are attached and baseline haemodynamic parameters [HR, NIBP, SpO2] are recorded. Povidine iodine solution is used for skin preparation. Spinal anaesthesia is given with Inj Bupivacaine heavy 2.2ml. Intravenous fluids are given liberally. No prophylactic vasopressors are used to prevent hypotension [Maternal Hypotension is defined as 1) a decrease in systolic blood pressure of more than 20% from baseline measurements or (2) a systolic blood pressure lower than 100 mm Hg.] Inj Mephentermine 6mg is given intravenously if there is hypotension. Breast feeding is usually initiated after shifting to Post-operative room which varies from immediate to few hours after shifting.

 In ERAC, the room temperature will be set to 23 degree Celsius, pregnant women  is shifted to operation theatre with secured and patent 18G IV cannula, all standard monitors are attached and baseline haemodynamic parameters [HR, NIBP, SpO2] are recorded. Spinal anaesthesia will be given with Inj Bupivacaine heavy 2.2ml + Inj Fentanyl 20 mcg.  Skin preparation will be done using Chlorhexidine solution. Controlled intravenous fluid management is done. Prophylactically vasopressors – Inj Phenylephrine infusion will be given at the rate of 25-50 mcg/min to prevent hypotension. Immediately after delivery of the baby , skin to skin contact of the baby with mother and immediate breast feeding is initiated.

 POST-OPERATIVE PERIOD

In conventional care anti-emetic Inj.Ondansetron 4mg is given SOS. Post-operative pain is managed by Inj Diclofenac BD IM and Inj Paracetamol 8th hourly. Foleys catheter removal after 24 hours. Mother will be discharged on the 5th day.

 In ERAC post-operatively anti-emetic Inj Ondansetron 4mg BD 12th hourly for 24 hrs is continued. The pain score of the mother will be assessed using VAS score [0-No pain 10-Worst pain] and multimodal analgesia will be given with Inj Paracetamol 1g 100ml 8th hourly and Inj Ketorolac 30mg stat intravenously and followed by 15mg IV every 6th hour for the duration of 24 hours , as and when the mother complains of pain ,considering maximum dose of 120mg/day. For any break  through pain(VAS>4) Inj Tramadol 100mg intravenous infusion will be given. Early oral intake has been preferred within 12 hours of the surgery. Foleys  catheter will be removed within 12 hours of the surgery. Early ambulation will be done within 6 hours of the surgery. Mother will be discharged on the 3rd  day.

 Implementation of ERAC probably decreases the length of stay and able to discharge early , better maternal satisfaction and maternal bonding with the baby. It also helps in decreasing the burden on maternal socio-economic status and health care system.


 
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