| CTRI Number |
CTRI/2024/07/070886 [Registered on: 19/07/2024] Trial Registered Prospectively |
| Last Modified On: |
19/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to improve the pain management, early recovery and less hospital stay after caesarean delivery |
|
Scientific Title of Study
|
A prospective randomised controlled trial to study
the benefit of Enhanced Recovery After
Surgery (ERAS) adoption in acute pain management after elective caesarean delivery. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sankarnarayanan R |
| Designation |
Junior Resident |
| Affiliation |
Blde deemed to be university |
| Address |
1st floor ot complex,
Department of Anesthesiology,
Shri B M Patil Medical College and hospital, Blde (DU).
Bijapur
KARNATAKA
586103
India |
| Phone |
9944981869 |
| Fax |
|
| Email |
sankarmbbs@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shivanand Karigar |
| Designation |
Professor |
| Affiliation |
Shri B M Patil Medical College and hospital |
| Address |
1st floor ot complex and labour ot complex,
Department of Anesthesiology,
Shri B M Patil Medical College and hospital,
Vijayapura.
Bijapur
KARNATAKA
586103
India |
| Phone |
9164319345 |
| Fax |
|
| Email |
shivanandkarigar82@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shivanand Karigar |
| Designation |
Professor |
| Affiliation |
Shri B M Patil Medical College and hospital |
| Address |
1st floor ot complex,
Department of Anesthesiology,
Shri B M Patil Medical College and hospital
Bijapur
KARNATAKA
586103
India |
| Phone |
9164319345 |
| Fax |
|
| Email |
shivanandkarigar82@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri B M Patil Medical College and hospital,
Blde deemed to be university,
Solapur road, vijayapura,
586103 Karnataka, India. |
|
|
Primary Sponsor
|
| Name |
Shri B M Patil Medical College and hospital |
| Address |
Blde deemed to be university,
Solapur road, vijayapura 586103, Karnataka, India
|
| Type of Sponsor |
Research institution and hospital |
|
|
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 Shivanand Karigar |
Shri B M Patil Medical College and hospital |
1st floor ot complex
Department of Anesthesiology
Blde deemed to be university
Bijapur
KARNATAKA |
9164319345
shivanandkarigar82@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BLDE(DU)/IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O94||Sequelae of complication of pregnancy, childbirth, and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ERAS PROTOCOL FOR CAESAREN SECTION, |
Bilateral TAP block with total 40mLs of Ropivacaine 0.5%, with 2 mLs of 8mg Decadron.
Inj. Granisetron 3mg just before incision. |
| Comparator Agent |
ROUTINE PROTOCOL FOR CAESAREAN SECTION |
Postoperative pain management with opioids and NSAIDS, routine mobilization protocol, nil per oral for 4 hours. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Parturient scheduled for planned Caesarean delivery
ASA grades I and II |
|
| ExclusionCriteria |
| Details |
Hypotension /Hypertension
Obesity
Fetal compromise
Preterm gestation
Coagulopathies
Maternal age less than 25 years
Allergy to study agents
Contraindications to TAP block,
Refusal to participate in the study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Post operative pain intensity and decrease in opioid consumption |
At 24th hour and 48 hours from the time of incision. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Perioperative discomfort, satisfaction score,length of stay, hospitalization cost. |
At 24th & 48th hour after incision,at the time of discharge from hospital |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
29/07/2024 |
| Date of Study Completion (India) |
14/02/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Published via Cureus journal |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
A Prospective Randomized Controlled Trial to Study The Advantage of Implementation of Enhanced Recovery After Surgery (ERAS) in Acute Pain Management During Elective Caesarean Delivery.
GUIDE: Dr. Shivanand L Karigar M.D.Anaesthesiology Associate Professor Shri B M Patil Medical College, shivanandkarigar82@gmail.com. |