| CTRI Number |
CTRI/2023/06/054114 [Registered on: 19/06/2023] Trial Registered Prospectively |
| Last Modified On: |
25/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Association of post caesarean section pain with initiation of breastfeeding |
|
Scientific Title of Study
|
Association of post caesarean section pain with initiation of breastfeeding - a randomized controlled double blind 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 Gowri Nair K |
| Designation |
Post graduate |
| Affiliation |
Karnataka Institute of Medical Sciences |
| Address |
Post graduate Department of Anaesthesiology Karnataka Institute of Medical Sciences,Vidyanagar Hubli Dharwad Karnataka 580032 India
Dharwad
KARNATAKA
580032
India |
| Phone |
7356256671 |
| Fax |
|
| Email |
gowrinair663@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Madhuri S Kurdi |
| Designation |
Head of department |
| Affiliation |
Karnataka Institute of Medical Sciences |
| Address |
Head of Department, Department of Anaesthesiology Karnataka Institute of Medical Sciences,Vidyanagar Hubli Dharwad Karnataka 580032 India
Dharwad
KARNATAKA
580032
India |
| Phone |
9449590556 |
| Fax |
|
| Email |
drmadhuri_kurdi@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Madhuri S Kurdi |
| Designation |
Head of department |
| Affiliation |
Karnataka Institute of Medical Sciences |
| Address |
Head of Department, Department of Anaesthesiology Karnataka Institute of Medical Sciences,Vidyanagar Hubli Dharwad Karnataka 580032 India
Dharwad
KARNATAKA
580032
India |
| Phone |
9449590556 |
| Fax |
|
| Email |
drmadhuri_kurdi@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Karnataka Institute of Medical Sciences,vidyanagar, hubli |
|
|
Primary Sponsor
|
| Name |
Dr Gowri Nair K |
| Address |
Post graduate Department of Anaesthesiology Karnataka Institute of Medical Sciences, Vidyanagar Hubli |
| 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 Gowri Nair K |
Karnataka Institute of Medical Sciences |
Department of Anaesthesiology Room number 206 Vidyanagar Room no 206 Vidyanagar Hubli
Dharwad
KARNATAKA |
7356256671
gowrinair663@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, KIMS Hubli |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Primigravidae aged between 20-40 yrs of ASA 2 and 3 posted for elective and emergency caesarean section under subarachnoid block with singleton live pregnancy at KIMS Hubballi |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Rectal diclofenac suppository 100mg |
Suppository is inserted immediately after caesarean section |
| Intervention |
Usg guided transversus abdominis plane block |
Bupivacaine 0.25% 20ml on each side is given immediately after caesarean section |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1)Primigravida undergoing elective or emergency caesarean section
2)Age group of 20 to 40 years
3)Singleton live pregnancy
4)Physical status of ASA II/III grading
5)Caesarean section done under subarachnoid block
|
|
| ExclusionCriteria |
| Details |
1)Presence of pregnancy induced hypertension, gestational diabetes mellitus, post partum hemorrhage, intraoperative and postoperative complication
2)Presence of psychiatric conditions
3)Primigravida with caesarean section done under subarachnoid block converted to general anaesthesia or any sedative agent administered during caesarean section |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Onset of pain after caesarean section |
Onset of pain assessed by verbal numerical score at 0,1,6,8 hours after caesarean section |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Effect of anxiety on post caesarean section pain |
Level of anxiety checked at 30 min before surgery or at time of pre anaesthetic evaluation |
| Change in intensity of incision pain during breastfeeding |
Assessed at 0,1,6,8 hours after caesarean section |
| Assess relationship between breastfeeding & uterine cramping pain post caesarean section |
Assessed at 0,1,6,8 hours after caesarean section |
|
|
Target Sample Size
|
Total Sample Size="105"
Sample Size from India="105"
Final Enrollment numbers achieved (Total)= "105"
Final Enrollment numbers achieved (India)="105" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
01/07/2023 |
| Date of Study Completion (India) |
01/08/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
01/08/2024 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Post caesarean pain is an important and often neglected outcome. Effective post caesarean section analgesia is an important factor that affects early initiation of breastfeeding in the immediate postnatal period. This study is a randomized single centre double blind controlled study assessing the effect of rectal diclofenac suppository and USG guided transversus abdominis plane block on post caesarean section pain and how it affects initiation of breastfeeding |