| CTRI Number |
CTRI/2022/07/044230 [Registered on: 21/07/2022] Trial Registered Prospectively |
| Last Modified On: |
08/01/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A comparison study to understand which is better between injection paracetamol and injection tramadol as anaesthetic agent to reduce pain during delivery |
|
Scientific Title of Study
|
A Randomised Controlled Trial To Compare The Efficacy Of Intravenous Paracetamol And Intramuscular Tramadol As Labor Analgesic |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Priyanka Bhuvanendran |
| Designation |
junior resident |
| Affiliation |
SHRI B M PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
| Address |
DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY
SHRI B M PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE , VIJAYAPURA , KARNATAKA
Bijapur
KARNATAKA
586103
India |
| Phone |
9605415233 |
| Fax |
|
| Email |
drpriyanka.jb@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neelamma Patil |
| Designation |
professor and unit chief |
| Affiliation |
SHRI B M PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
| Address |
DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY
SHRI B M PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE , VIJAYAPURA , KARNATAKA
Bijapur
KARNATAKA
586103
India |
| Phone |
8106725928 |
| Fax |
|
| Email |
neelamma.patil@bldedu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neelamma Patil |
| Designation |
professor and unit chief |
| Affiliation |
SHRI B M PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
| Address |
DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY
SHRI B M PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE , VIJAYAPURA , KARNATAKA
Bangalore Rural
KARNATAKA
586103
India |
| Phone |
8106725928 |
| Fax |
|
| Email |
neelamma.patil@bldedu.ac.in |
|
|
Source of Monetary or Material Support
|
| SHRI B M PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE , BLDE (DEEMED TO BE UNIVERSITY ) |
|
|
Primary Sponsor
|
| Name |
Dr Priyanka Bhuvanendran |
| Address |
DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY BLDE (DEEMED TO BE UNIVERSITY) SHR B M PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE VIJAYAPURA - 586103 |
| Type of Sponsor |
Other [myself Dr Priyanka Bhuvanendran] |
|
|
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 PRIYANKA BHUVANENDRAN |
Shri B M Patil Medical College |
DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY, Room number 2, SHRI B M PATIL MEDICAL COLLEGE BLDE (DEEMED TO BE UNIVERSITY ), Smt Bangaramma Sajjan Campus , Dr B M Patil Road ( Solapur Road ) Vijayapura (Bijapur) - 586103 , KARNATAKA , BIJAPUR
Bijapur
KARNATAKA |
9606415233
drpriyanka.jb@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O80||Encounter for full-term uncomplicated delivery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
paracetamol and tramadol |
comparison between injection paracetamol 1000mg intravenous and injection tramadol intra muscular 1 ampule 100mg stat dose after 4 cm of cervical dilatation as labor analgesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
primigravida with period of gestation >37 weeks with vertex presentation in active labour with cervical dilatation of >4cm , with cervical effacement >60% with singleton pregnancy |
|
| ExclusionCriteria |
| Details |
women with clinical evidence of cephalopelvic disproportion , multiparous , malpresentation , multiple pregnancies , previously scarred uterus , preterm labour , induced labour , antepartum haemorrhage , preeclampsia , history of drug allergies , history of medical disorders like cardiac , renal , liver diseases , intrauterine foetal demise , history of cervical incompetence , oligohydramnios , fetal growth restrictions , congenital anomalies in the foetus , cervical dilatation > 6 cm |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
If paracetamol proves to be a better and safe analgesic than tramadol.
it can be used regularly as a safe labour analgesic |
labour pain assessed after giving paracetamol or tramadol during labour at 0 hour , 1 hour , 3 hour , 2nd stage of labour , 1 hour after delivery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| fetal outcome after the administration of injection tramadol and paracetamol as labor analgesia |
Apgar score at 1 minute and 5 minute and followed by babies observation for any distress for next 4 hours |
|
|
Target Sample Size
|
Total Sample Size="220"
Sample Size from India="220"
Final Enrollment numbers achieved (Total)= "220"
Final Enrollment numbers achieved (India)="220" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
14/09/2022 |
| Date of Study Completion (India) |
04/01/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="2"
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
|
the study is used for comparing which drug among paracetamol and tramadol , is better during labour for pain relief and smooth delivery of the baby without much fetal distress and economically feasible |