| 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
|
|
|
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
|
|
|
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. |