| CTRI Number |
CTRI/2025/03/082713 [Registered on: 19/03/2025] Trial Registered Prospectively |
| Last Modified On: |
14/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Normal delivery using epidural anaesthesia with total painless method |
|
Scientific Title of Study
|
Effectiveness of levobupivacaine and ropivacaine for epidural labour analgesia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Yashwant S M |
| Designation |
Junior Resident, Gandhi Medical College |
| Affiliation |
Gandhi Medical College |
| Address |
Gandhi Medical College Second Floor Department of Anaesthesiology Sultania Road Bhopal
Bhopal
MADHYA PRADESH
462001
India |
| Phone |
8056436888 |
| Fax |
|
| Email |
yashw9@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Brajesh Kaushal |
| Designation |
Associate Professor, Department of Anesthesiology |
| Affiliation |
Gandhi Medical College |
| Address |
Block A Second Floor Operation Theatre Gandhi Medical College and Associated Hamidia Hospitals Bhopal M.P.
Bhopal
MADHYA PRADESH
462001
India |
| Phone |
9425772151 |
| Fax |
|
| Email |
brajeshkaushal3@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajkumar Ahirwal |
| Designation |
Associate Professor, Department of Anesthesiology |
| Affiliation |
Gandhi Medical College |
| Address |
Block A Second Floor Operation Theatre Gandhi Medical College and Associated Hamidia Hospitals Bhopal M.P.
Bhopal
MADHYA PRADESH
462001
India |
| Phone |
9826742427 |
| Fax |
|
| Email |
drrajkumarahirwal@ymail.com |
|
|
Source of Monetary or Material Support
|
| Gandhi Medical College
Block A Second Floor Operation Theatre Gandhi Medical College and Associated Hamidia Hospitals
Bhopal
MADHYA PRADESH
India 462001 |
|
|
Primary Sponsor
|
| Name |
Gandhi Medical College Bhopal Madhya Pradesh |
| Address |
Sultania Road Royal Market Bhopal Madhya Pradesh |
| 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 |
| Dr Brajesh Kaushal |
Hamidia Hospital |
Labour Room Second Floor Block B Department of Obstetrics and Gynaecology Gandhi Medical College Sultania Road Bhopal Madhya Pradesh India 462001
Bhopal
MADHYA PRADESH |
9425772151
brajeshkaushal3@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional Ethics Committee Gandhi Medical College Bhopal MP INDIA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Full Term Pregnant women presenting with active stage of labour |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Levobupivacaine plain |
19 G epidural catheter inserted at L4-L5 interspace under Local anaesthesia and Inj. Levobupivacaine 0.2% 12 ml as bolus via epidural catheter at the time of more than 3 cm of cervical dilatation followed by 0.1% levobupivacaine infusion @ 6 ml/hr via epidural catheter till delivery of the baby |
| Comparator Agent |
Ropivacaine plain |
19 G epidural catheter inserted at L4-L5 interspace under Local anaesthesia and Inj. Ropivacaine 0.2% 12 ml as bolus via epidural catheter at the time of more than 3 cm of cervical dilatation followed by 0.1% Ropivacaine infusion @ 6 ml/hr via epidural catheter till delivery of the baby |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Full Term Female Pregnant Women
Singleton Pregnancy and Vertx Presentation
Active stage of labour
ASA Grade I |
|
| ExclusionCriteria |
| Details |
Cardiovascular disease, Neuromuscular diseases Major sicknesses like bronchial asthma and tuberculosis
Severe eclampsia
Received opioid or sedative drugs
Drug allergies
Physical disability |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the overall effectiveness of levobupivacaine or ropivacaine in terms of onset,quality of analgesia and degree of motor blockade |
study start from Epidural catheter insertion to the delivery of baby and removal of catherer followed by 6 hrs after delivery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To Assess the maternal fetal outcome & maternal satisfaction score |
at the time of delivery of the baby & thereafter every hour till 6 hrs after delivery |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
07/04/2025 |
| 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="11"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [yashw9@gmail.com].
- For how long will this data be available start date provided 05-02-2025 and end date provided 05-02-2028?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The patients will receive nil per oral instructions before the labour. After shifting the patients to the labour analgesia room, standard non-invasive anaesthetic monitoring like blood pressure, five leads electrocardiography and pulse oximetry will be connected to the patient. Baseline vitals such as heart rate, blood pressure, mean arterial pressure, and oxygen saturation of the patient will be recorded after 5 mins settling in the labour analgesia room. An intravenous line will be established. The epidural space will be found using an 18-gauge Tuohy needle at either L2–L3 or L3–L4 in the sitting position. Loss of resistance will be used to identify the epidural space. Epidural catheter will be inserted up to the desired length and secured at L2-L3 or L3-L4. For the study, the test dose will be omitted. Levobupivacaine or ropivacaine will be diluted with 0.9% w/v saline to achieve the desired concentration at room temperature. For initiation of labour analgesia, first bolus administration (12ml of 0.2%) of levobupivacaine or ropivacaine will be given over 5 minutes when cervical dilatation will become >3 cm and then analgesia will be maintained with infusion of 0.1% levobupivacaine or 0.1% ropivacaine till the delivery of the baby. |