| CTRI Number |
CTRI/2021/01/030532 [Registered on: 18/01/2021] Trial Registered Prospectively |
| Last Modified On: |
15/01/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
EARLY RECOVERY IN CAESAREAN DELIVERY |
|
Scientific Title of Study
|
IMPLEMENTATION OF ENHANCED RECOVERY AFTER SURGERY (ERAS) PROTOCOL IN ELECTIVE CAESAREAN SECTION: 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 ADITI SINGH BAGHEL |
| Designation |
POST GRADUATE RESIDENT |
| Affiliation |
GEETANJALI MEDICAL COLLEGE AND HOSPITAL |
| Address |
DEPARTMENT OF ANESTHESIOLOGY, GEETANJALI MEDICAL COLLEGE AND HOSPITAL, UDAIPUR
DEPARTMENT OF ANESTHESIOLOGY, GEETANJALI MEDICAL COLLEGE AND HOSPITAL, UDAIPUR
Udaipur
RAJASTHAN
313002
India |
| Phone |
7987620110 |
| Fax |
|
| Email |
adi.tanu07@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR KARUNA SHARMA |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
GEETANJALI MEDICAL COLLEGE AND HOSPITAL |
| Address |
DEPARTMENT OF ANESTHESIOLOGY, GEETANJALI MEDICAL COLLEGE AND HOSPITAL, UDAIPUR
DEPARTMENT OF ANESTHESIOLOGY, GEETANJALI MEDICAL COLLEGE AND HOSPITAL, UDAIPUR
Udaipur
RAJASTHAN
313002
India |
| Phone |
|
| Fax |
|
| Email |
drkarunasharma07@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SUNANDA GUPTA |
| Designation |
PROFESSOR AND HEAD OF DEPARTMENT OF ANESTHESIOLOGY |
| Affiliation |
GEETANJALI MEDICAL COLLEGE AND HOSPITAL |
| Address |
DEPARTMENT OF ANESTHESIOLOGY, GEETANJALI MEDICAL COLLEGE AND HOSPITAL, UDAIPUR
DEPARTMENT OF ANESTHESIOLOGY, GEETANJALI MEDICAL COLLEGE AND HOSPITAL, UDAIPUR
Udaipur
RAJASTHAN
313002
India |
| Phone |
|
| Fax |
|
| Email |
sunandagupta@hotmail.com |
|
|
Source of Monetary or Material Support
|
| GEETANJALI MEDICAL COLLEGE AND HOSPITAL, MANWA KHEDA, NH-8 BYPASS, NEAR EKLINGPURA CHOURAHA, UDAIPUR, RAJASTHAN 313002 |
|
|
Primary Sponsor
|
| Name |
DR ADITI SINGH BAGHEL |
| Address |
DEPARTMENT OF ANESTHESIOLOGY, GEETANJALI MEDICAL COLLEGE AND HOSPITAL, UDAIPUR, RAJASTHAN , 313002 |
| 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 |
| DR SUNANDA GUPTA |
GEETANJALI MEDICAL COLLEGE AND HOSPITAL |
HIRANMAGRI EXTENSION, MANVAKHEDA, NH-8 BYPASS NEAR EKLINGAPURA CHOURAHA, UDAIPUR, 313002
Udaipur
RAJASTHAN |
02942500000
sunandagupta@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| HUMAN RESEARCH ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
HEALTHY HUMAN VOLUNTEERS POSTED FOR ELECTIVE CAESAREAN SECTION |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ERAC PROTOCOL: PRE-EMPTIVE ANALGESIA IN THE FORM OF NEOMOL SUPPOSITORY |
ERAC PROTOCOL:PRE-OPERATIVE REDUCED NBM HOURS 6 HOURS FOR SOLID, 2 HOURS FOR CLEAR LIQUIDS. HIGH CARBOHYDRATE DIET-100gm glucose in 800 ml water night before surgery and 50 gm glucose in 100 ml water 2 hours before surgery.
Pre-emptive analgesia in the form of rectal neomol (250mg) suppository.
Part preparation and surgical site preparation with chlorhexidine.
Intra-operative- inj. dexamethasone 8 mg iv stat, any decrease in blood pressure (below 20% of basal reading) will be managed prophylactically by inj. phenylephrine infusion @ 20mcg/min in all patients after placing them in supine position after spinal anesthesia, in case of resistant hypotension (to phenylephrine)infusion of nor-adrenaline(80 mcg/ml) @5 ml/hr will be started and tapered accordingly.
Post-operatively- early breastfeeding will be initiated within 1 hour after delivery, lozenges given at 2 hours, clear fluids at 4 hours, semisolids at 8 hours after surgery, early de-catheterization within 6 hours, and early ambulation within 6-8 hours of surgery.
Analgesics: inj PCM 0.45 gm 6 hourly and inj diclofenac sodium 75 mg 8 hourly with inj tramadol 100 mg iv as rescue analgesic as per requirment. |
| Comparator Agent |
TRADITIONAL PROTOCOL: no pre-emptive analgesia |
TRADITIONAL PROTOCOL: NBM 12 hours before surgery with no pre-emptive analgesia.
Part preparation and surgical site preparation with povidone iodine, intraoperative hypotension will be managed by giving bolus of inj. phenylephrine 50mcg stat iv.
Post-operative- clear fluids at 8 hours, semisolid after 24 hours of surgery late de-catheterization (24 to 72 hours)and late ambulation (after 12-24 hours),
Analgesia - inj. diclofenac sodium 75 mg 8 hourly and diclofenac patch (as per requirement |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
patients of ASA grade I-II scheduled for elective caesarean section surgery |
|
| ExclusionCriteria |
| Details |
pre existing cardiac disease
diabetes
auto-immune disorder
severe and uncontrolled hypertension
severe and uncontrolled hypo/hyperthyrodism
Rh negative mother
abnormal placentation
severe renal hepatic dysfunction
neurological and psychiatric diseases
patient refusal
any contraindication for spinal analgesia |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the total duration of stay in the hospital between ERAC and TRADITIONAL protocol |
From day of admission to day of discharge |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare ERAC and TRADITIONAL protocol in terms of -
1.post-operative pain
2.any intra-operative/post-operative adverse effects
3.rate of readmission
4.initiation of breast feeding
5.barriers in implimentation |
from day of admission to day of discharge |
|
|
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)
|
21/01/2021 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Implementation of enhanced recovery after surgery ( ERAS) protocol in elective caesarean section - A prospective observational study : as a topic for thesis for award of the degree of doctor of medicine ( M.D. ANESTHESIOLOGY) being undertaken as a prospective observational study comprising of all the patients admitted in GMCH for elective caesarean section. A minimum of 200 patients will be randomized into 2 groups ( 100 in ERAC protocol and rest 100 in control group {following traditional protocol} ) by computer generated radomization using microsoft excel program. |