| CTRI Number |
CTRI/2025/02/080681 [Registered on: 17/02/2025] Trial Registered Prospectively |
| Last Modified On: |
08/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study to Compare Effects Of Isobaric Levobupivacaine and Isobaric Ropivacaine In Labor Analgesia |
|
Scientific Title of Study
|
Study to Compare Effects Of Isobaric Injection Levobupivacaine and Isobaric Injection Ropivacaine In Labor Analgesia |
| Trial Acronym |
LECRA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anil Kumar |
| Designation |
Assistant Professor |
| Affiliation |
Government Medical College Jalaun |
| Address |
Department of Anesthesia Government Medical College, Jalaun(Orai) 285001 First Floor Room Number 2
Jalaun
UTTAR PRADESH
285001
India |
| Phone |
9454224498 |
| Fax |
|
| Email |
dranilkumarucr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunit Kumar |
| Designation |
Associate Professor |
| Affiliation |
Government Medical College Jalaun |
| Address |
Department of Anesthesia Government Medical College, Jalaun(Orai) 285001 First Floor Room Number 2
Jalaun
UTTAR PRADESH
285001
India |
| Phone |
9532456809 |
| Fax |
|
| Email |
sunit.sachan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anil Kumar |
| Designation |
Assistant Professor |
| Affiliation |
Government Medical College , Jalaun |
| Address |
Department of Anesthesia Main Block ,First Floor, Room number 2
Government Medical College , Jalaun (Orai)
Jalaun
UTTAR PRADESH
285001
India |
| Phone |
9454224498 |
| Fax |
|
| Email |
dranilkumarucr@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Medical College , Jalaun(Orai) 285001
Uttar Pradesh, India |
|
|
Primary Sponsor
|
| Name |
Government Medical College Jalaun Orai |
| Address |
Department Of Anesthesia, Government Medical College, First Floor Room number 2
Jalaun(Orai) 285001, Uttar 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 Anil Kumar |
Rajkiya Medical college , Orai, Jalaun |
Hospital Block, O.T. Complex Government Medical College, Jalaun
Jalaun
UTTAR PRADESH |
9454224498
dranilkumarucr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| government Medical college Jalaun Institute Ethical Committee ( Human Studies) |
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 |
INJECTION LEVOBUPIVACAINE |
INJECTION LEVOBUPIVACAINE 25 mg loading dose and then 10mg per hour till delivery |
| Comparator Agent |
INJECTION ROPIVACAINE |
INJECTION ROPIVACAINE 37.5 mg loading dose then 15 mg per hour till delivery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
all pregnant females of age 18 years TO 40 years |
|
| ExclusionCriteria |
| Details |
1 Uncontrolled diabetes and hypertension.
2 Chronic renal diseases
3 Chronic Anemia
4 I.H.D. or any other cardiac condition.
5 Peripheral vascular disease |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Maternal blood pressure
pain relief
preservation of lower limb motor power
duration and progress of labor
fetal outcome were evaluated |
BASELINE, 6 HOURS AND 12 HOURS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| hemodynamic stability |
12 HOURS AND 24 HOURS AFTER SURGERY |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
20/02/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [dranilkumarucr@gmail.com].
- For how long will this data be available start date provided 27-03-2025 and end date provided 28-01-2026?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
This study was taken to compare the effects on the labor
and neonates
of segmental epidural analgesia conducted
with Levobupivacaine and
Ropivacaine with
fentanyl as opioid as adjuvant . 90 parturients were included in the study.
They were randomly divided in two groups. patients received levobupivacaine and
ropivacaine , Epinephrine was not added
to local anesthetics. The first dose was 25 mg of levobupivacaine 0.25% (10 ml) and 10 micro gram of inj. Fentanyl
and 37.5 mg for Ropivacaine 0.375% (10 ml). Reinjections occurred every 60 min
for levobupivacaine ( 10 mg) and ever 60
min for Ropivacaine (15 mg).. Umbilical cord
blood was drawn for pH determination. Patients in both the groups were
compared for Maternal blood
pressure, pain relief, preservation of lower limb motor power, duration and
progress of labour, and foetal outcome were evaluated , and need for emergency caesarean section is
considered
|