| CTRI Number |
CTRI/2025/03/081977 [Registered on: 07/03/2025] Trial Registered Prospectively |
| Last Modified On: |
04/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Clinical trial to study the efficacy of magnesium sulphate as an adjuvant to Ropivacaine and fentanyl mixture in labor analgesia |
|
Scientific Title of Study
|
Epidural labor analgesia evaluation of efficacy of magnesium sulphate as an adjuvant to Ropivacaine and fentanyl mixture |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Veeramalla Pooja |
| Designation |
Postgraduate |
| Affiliation |
Government Medical college |
| Address |
Government medical college
putlampalli
kadapa
Cuddapah
ANDHRA PRADESH
516002
India |
| Phone |
8790100375 |
| Fax |
|
| Email |
dr.poojaveeramalla@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
C Sunil |
| Designation |
Professor and Head of the Department |
| Affiliation |
Government Medical college,kadapa |
| Address |
Government medical college
putlampalli
kadapa
Andhra Pradesh 516002
Cuddapah
ANDHRA PRADESH
516002
India |
| Phone |
8790100375 |
| Fax |
|
| Email |
dr.sunil.chiruvella@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Veeramalla Pooja |
| Designation |
Postgraduate |
| Affiliation |
Government Medical college,Kadapa |
| Address |
Government medical college
putlampalli
kadapa
Cuddapah
ANDHRA PRADESH
516002
India |
| Phone |
8790100375 |
| Fax |
|
| Email |
dr.poojaveeramalla@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government medical college,Putlampalli ,Kadapa,Andhra Pradesh-516002 |
|
|
Primary Sponsor
|
| Name |
Government medical collegeKadapa |
| Address |
Government medical college
putlampalli
Kadapa Andhra Pradesh-516002 |
| 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 |
| DrVeeramalla pooja |
Government medical college kadapa |
Department of anaesthesiology putlampalli
Kadapa Andhra Pradesh -516002
Cuddapah
ANDHRA PRADESH |
8790100375
dr.poojaveeramalla@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GOVERNMENT MEDICAL COLLEGE KADAPA |
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 labor analgesia |
Epidural labor analgesia using mixture of Ropivacaine with fentanyl and Ropivacaine fentanyl mixture with magnesium sulphate |
| Comparator Agent |
Ropivacaine fentanyl mixture and Ropivacaine fentanyl and magnesium sulphate mixture |
Comparison of Total 12 mL of 0.125%Ropivacaine mixed with fentanyl 25ug versus 0.125% Ropivacaine mixed with 25ug fentanyl and 50mg magnesium sulphate |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
33.00 Year(s) |
| Gender |
Female |
| Details |
Primi parturient
American society of anaesthesiologists physiological status II
Cervical dilatation with 3 cm |
|
| ExclusionCriteria |
| Details |
Parturients with bleeding disorders
Parturients with local or systemic sepsis
Parturients with known hypersensitivity to study drugs
Parturients with spinal deformities those who has undergone spinal surgeries
Parturient’s with PIH CPD breech presentation multiparty ,GDM ,multiple or high risk surgeries
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare onset of analgesia between both groups |
1,3,5 ,10 mins |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare duration of analgesia between two groups
To detect difference in numerical rating scale between two groups
To study maternal e pulsi e efforts & neonatal outcomes in two groups
To assist mode of delivery percentage of normal vaginal deliveries assisted vaginal deliveries & Caesarian section in two groups |
O 5 15 30 45 60 120 180 minutes |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
12/03/2026 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
A STUDY TITLED ’EPIDURAL LABOR ANALGESIA -EVALUATION OF EFFICACY OF MAGNESIUM SULPHATE AS AN ADJUVANT TO ROPIVACAINE AND FENTANYL MIXTURE ’ WAS CARRIED OUT IN GOVERNMENT GENERAL HOSPITAL,KADAPA DURING THE PERIOD FROM OCTOBER 2022-MARCH 2024 THIS STUDY INCLUDED 80 PRIMI PARTURIENTS DIVIDED RANDOMLY INTO TWO GROUPS EACH 40 PATIENTS .IN GROUP A PARTURIENTS RECEIVED TOTAL VOLUME OF 12 ML OF 0.125% ROPIVACAINE PLUS 25MCG FENTANYL FOR EPIDURAL LABOR ANALGESIA.ADITIONALLY,AN EPIDURAL TOP UP OF 9ML OF 0.125% ROPIVACAINE WAS ADMINISTERED WHEN THE NUMERICAL RATING SCALE SCORE WAS MORE THAN 3.IN CONTRAST GROUP B RECEIVED THE SAME VOLUME OF 12 ML OF 0.125% ROPIVACAINE PLUS 25MCG FENTANYL AND 50MG MAGNESIUM SULPHATE FOR EPIDURAL LABOR ANALGESIA.SIMILARLY,AN EPIDURAL TOP UP OF 9ML OF 0.125% ROPIVACAINE WAS ADMINISTERED WHEN THE NRS SCORE WAS MORE THAN 3. DEMOGRAPHIC DATA WERE COMPARABLE IN BOTH GROUPS .OUR STUDY MONITORED PARAMETERS INCLUDING ONSET AND DURATION OF ANALGESIA ,NRS SCORES ,NUMBER OF TOP UPS ,MATERNAL EXPULSIVE EFFORTS,MODE OF DELIVERY,APGAR SCORES AND HEMODYNAMIC VARIABLES. FINDINGS REVEALED A SIGNIFICANTLY FASTER ONSET OF ANALGESIA IN GROUP B COMPARED TO GROUP A WITH SIGNIFICANTLY LONGER DURATION OF ANALGESIA IN GROUP B AS WELL.MATERNAL EXPULSIVE EFFORTS AND MODE OF DELIVERY WERE COMPARABLE BETWEEN BOTH GROUPS.ADDITIONALLY THERE WERE NO STASTICAL DIFFERENCE IN APGAR SCORES AT 1 MINUTE AND 5 MINUTES BETWEEN TWO GROUPS |