| CTRI Number |
CTRI/2024/05/067125 [Registered on: 09/05/2024] Trial Registered Prospectively |
| Last Modified On: |
08/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Levobupivacaine vs Ropivacaine for Epidural Labor Analgesia and Maternal and Fetal outcome |
|
Scientific Title of Study
|
A Comparative Study Between Levobupivacaine and Ropivacaine for Epidural labour Analgesia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shafaque Maqusood |
| Designation |
Junior Resident |
| Affiliation |
Datta Meghe Institute of Medical Science and research |
| Address |
Department of Anaesthesiology, 2nd Floor, Shalinitai superspeciality building, Sawangi, Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
7827716393 |
| Fax |
|
| Email |
maqusoodshafaque@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vivek Chakole |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Medical Science and research |
| Address |
Department of Anaesthesiology, 2nd Floor, Shalinitai superspeciality building, Sawangi, Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
7583836564 |
| Fax |
|
| Email |
drvivekchakole@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shafaque Maqusood |
| Designation |
Junior Resident |
| Affiliation |
Datta Meghe Institute of Medical Science and research |
| Address |
Department of Anaesthesiology, 2nd Floor, Shalinitai superspeciality building, Sawangi, Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
7827716393 |
| Fax |
|
| Email |
maqusoodshafaque@gmail.com |
|
|
Source of Monetary or Material Support
|
| Acharya Vinoba Bhave Rural Hospital, Datta Meghe Institute of higher education and research, Jawaharlal Nehru medical college , Sawangi , Wardha, 442001 , India |
|
|
Primary Sponsor
|
| Name |
JNMC |
| Address |
sawangi , wardha |
| Type of Sponsor |
Private 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 |
| SHAFAQUE MAQUSOOD |
Jawaharlal Nehru Medical College |
Department of Anaesthesiology, 2nd Floor, Shalinitai superspeciality building, Sawangi, Wardha
Wardha
MAHARASHTRA |
7827716393
maqusoodshafaque@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS 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, (2) ICD-10 Condition: O80||Encounter for full-term uncomplicated delivery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Inj. Levobupivacaine administered as a local anesthetic agent for epidural labor analgesia |
This intervention will be done on patients undergoing epidural labour analgesia for a period of 2 years with 0.1% 12 ml of levobupivacaine given as bolus and repeated every time patient has pain during labour untill delivery of baby |
| Comparator Agent |
Inj. Ropivacaine will be administered as a local anesthetic agent in patients undergoing epidural labour analgesia |
This intervention will be done on patients undergoing epidural labour analgesia for a period of 2 years with 0.1% 12ml Ropivacaine given as bolus and repeated whenever patient has pain during labour untill delivery of the baby |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
32.00 Year(s) |
| Gender |
Female |
| Details |
Asa Grade 1 & 2
Primigravidae With Singleton Uncomplicated Pregnancy
Asa Grade 1 & 2
All Patients Willing To Give Informed Written Consent
|
|
| ExclusionCriteria |
| Details |
Asa Class 3 Or Higher
High Risk Complicated Pregnancy
Contraindication Of Neuraxial Block
Patient With Bleeding Disorder
Patients With Psychiatric Illness
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| In Epidural labor Analgesia, levobupivacaine has demonstrated superior efficacy compared to ropivacaine. |
2 YEARS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
APPRAISE HAEMODYNAMIC DURING LABOUR
ASSESS THE MATERNAL AND FOETAL OUTCOME
|
2 YEARS |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 2 |
|
Date of First Enrollment (India)
|
19/05/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
19/05/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
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 - NO
|
|
Brief Summary
|
While
Ropivacaine Initiates Analgesia More Quickly, Levobupivacaine Provides A
Longer-Lasting Effect. Both Drugs Are Safe and Result In Comparable Maternal
And Fetal Outcomes. It’s Important To Consider These Factors Along With Individual
Patient Circumstances When Choosing An Anaesthetic For Epidural Labor
Analgesia.
|