| CTRI Number |
CTRI/2021/03/032404 [Registered on: 30/03/2021] Trial Registered Prospectively |
| Last Modified On: |
26/03/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Acomparative study on effect of levobupivacaine versus ropivacaine with fentanyl as add on for patient controlled epidural labour analgesia. |
|
Scientific Title of Study
|
Levobupivacaine versus ropivacaine with fentanyl as an adjuvant for patient controlled epidural labour analgesia- A comparative 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 Mrinalini Verma |
| Designation |
Pg Student |
| Affiliation |
|
| Address |
Department of Anesthesiology and critical care Pt JNM Medical college Raipur
Raipur
CHHATTISGARH
492001
India |
| Phone |
9770778764 |
| Fax |
|
| Email |
Mrinaliniverma34@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr JAYA LALWANI |
| Designation |
Professor |
| Affiliation |
|
| Address |
Department of Anesthesiology and critical care Pt JNM Medical college Raipur
Raipur
CHHATTISGARH
492001
India |
| Phone |
9300224989 |
| Fax |
|
| Email |
jayalalwani2020@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr JAYA LALWANI |
| Designation |
Professor |
| Affiliation |
|
| Address |
Department of Anesthesiology and critical care Pt JNM Medical college Raipur
Raipur
CHHATTISGARH
492001
India |
| Phone |
9300224989 |
| Fax |
|
| Email |
jayalalwani2020@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Bhimrao Ambedkar Memorial hospital Raipur |
|
|
Primary Sponsor
|
| Name |
Dr Jaya Lalwani |
| Address |
Department of Anesthesiology and critical care PT JNM Medical college Raipur |
| 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 MRINALINI VERMA |
DR BHIMRAO AMBEDKAR MEMORIAL HOSPITAL RAIPUR |
PT. JNM MEDICAL COLLEGE RAAIPUR CHHATTISGARH
Raipur
CHHATTISGARH |
9770778764
Mrinaliniverma34@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee PT JNM Medical college Raipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Epidural labour analgesia with Patient controlled epidural analgesia pump |
1.Levobupivacaine 0.1% with 2mcg/ml fentanyl through PCEA pump
|
| Comparator Agent |
Epidural labour analgesia with Patient controlled epidural analgesia pump. |
Ropivacaine 0.1% with 2 mcg/ml fentanyl through PCEA pump. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. ASA physical status II
2.Parturients with cervical dilation <5 cm
3.Nulliparous labouring parturients with singleton pregnancy and vertex presentation who will request labour analgesia.
4. Non stress test of foetus should be normal. |
|
| ExclusionCriteria |
| Details |
1. Any contraindication to neuraxial block like
Patient reusal or uncooperative patient
Coagulopathy
History of allergy to study drugs
Skin infection in lumbar region.
2. Patients who had received parenteral opiods <2 hour earlier
3. Parturients with obsterics complications such as multiple pregnancies, prologed labour, PIH,Gestational diabetes, Oligohydromnios, Polyhydromnios, Bad obstetrics history, foetus. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Total dose requirement of levobupivacaine and ropivacaine with fentanyl as an adjuvant |
Hemodynamic parameters every 5 minute till 30 minute and every 15 minutes till delivery of fetus |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Total number of PCEA demand bolus
2.Total number of manual rescue boluses
3.Extent of sensory block
4.Mode of delivery
5. Maternal satisfaction score
6.Fetal outcome ( APGAR SCORE in 1 and 5 minutes, birth weight)
7. Side effects( Hypotension,, nausea, vomiting, pruritis, motor blockade) |
Fetal heart rate every 10 minutes till delivery of fetus and APGAR score at 1 minute and 5 minute and side effects like hypotension, nausea, vomiting, pruritus, motor blockade every 30 minutes. |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
31/03/2021 |
| 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
|
This is interventional randomised study to compare the effect of levobupivacaine and ropivacaine with fentanyl as an adjuvant for patient control epidural labour analgesia in parturient with ASA grade II physical state. It will be conducted in single center in India. The primary outcome measure will be total dose requirement of levobupivacaine and ropivacaine with fentanyl and secondary outcomes will be total number of PCEA demand boluses, total number of manual rescue boluses, extent of sensory block, maternal satisfaction score, mode of delivery, fetal outcome, side effects like hypotension, nausea, vomiting, pruritis , motor blockade. |