| CTRI Number |
CTRI/2022/05/042543 [Registered on: 13/05/2022] Trial Registered Prospectively |
| Last Modified On: |
08/05/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two different low concentrations of Ropivacaine for labor epidural analgesia |
|
Scientific Title of Study
|
" Epidural labor analgesia: A comparison of Ropivacaine 0.075% versus 0.1% with Fentanyl |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rashi |
| Designation |
PG 3rd year Resident in Anaesthesia department |
| Affiliation |
Sardar Patel Medical College |
| Address |
Department of Anesthesia,
SP Medical College,
Bikaner,
Rajasthan
Bikaner
RAJASTHAN
334003
India |
| Phone |
9773563380 |
| Fax |
|
| Email |
rashiyadavdr1994@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sonali Dhawan |
| Designation |
Senior Professor and Head of Department |
| Affiliation |
Sardar Patel Medical College |
| Address |
Department of Anesthesia,
SP Medical College,
Bikaner,
Rajasthan
Bikaner
RAJASTHAN
334003
India |
| Phone |
9414137866 |
| Fax |
|
| Email |
sonaligsoni@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sonali Dhawan |
| Designation |
Senior Professor and Head of Department |
| Affiliation |
Sardar Patel Medical College |
| Address |
Department of Anesthesia,
SP Medical College,
Bikaner,
Rajasthan
Bikaner
RAJASTHAN
334003
India |
| Phone |
9414137866 |
| Fax |
|
| Email |
sonaligsoni@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sardar Patel Medical College |
|
|
Primary Sponsor
|
| Name |
Sardar Patel Medical College |
| Address |
Department of Anesthesiology, Sardar Patel Medical College,
Bikaner,
Rajasthan |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Rashi |
Sardar Patel Medical College |
Department of Anesthesiology
Bikaner
RAJASTHAN |
9773563380
rashiyadavdr1994@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics and Research Board, Sardar Patel Medical College, Bikaner |
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 |
| Intervention |
Epidural catheter placement |
Epidural catheter is placed at L3- L4 Epidural space |
| Comparator Agent |
Ropivacaine 0.075% with fentanyl |
Labor epidural analgesia with Ropivacaine 0.075%, 10ml with 2 mcg/ml fentanyl |
| Comparator Agent |
Ropivacaine 0.075% with fentanyl |
Labor epidural analgesia with Ropivacaine 0.1%, 10ml with 2 mcg/ml fentanyl |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
a singleton fetus in cephalic presentation at term (>37 weeks gestation) belonging to ASA class 2 who requested epidural analgesia with no contraindication to epidural catheterization were selected and randomly divided into two groups. |
|
| ExclusionCriteria |
| Details |
1. Patients not giving consent
2. BMI>35kg/m2
3. Gestation diabetes
4. Hypertensive disorders
5. Premature Rupture of membranes
6. Coagulation disorder
7. Infection at the site of epidural prick
8. Past history of any drug reaction
9. Patients having psychiatric illness
10. Neurological deficits.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare duration of analgesia |
Upto delivery of parturient |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Onset of analgesia
2. Quality of analgesia (VAS)
3. No. of episodes of breakthrough pains
4. Duration of Labour
5. Incidence of motor block (Breen Modified Bromage Score)
6. Time from Epidural to Delivery
7. Foetal side effects
8. Parturient satisfaction
|
upto 30 minutes after delivery of parturient |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
23/05/2022 |
| 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="0"
Months="6"
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
|
Our aim is to compare two low concentrations of ropivacaine with fentanyl as an adjuvant for labor epidural analgesia |