| CTRI Number |
CTRI/2025/01/078986 [Registered on: 20/01/2025] Trial Registered Prospectively |
| Last Modified On: |
16/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Clinical Trial to study the duration of effects between two drugs Ropivacaine Heavy and Bupivacaine Heavy in pregnant women |
|
Scientific Title of Study
|
A COMPARATIVE EFFICACY BETWEEN 0.5 percent ROPIVACAINE HEAVY VS 0.5 percent BUPIVACAINE HEAVY FOR INTRATHECAL ANAESTHESIA IN CEASAREAN SECTION - A PROSPECTIVE, DOUBLE-BLIND RANDOMISED CONTROLLED TRIAL |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shilpi Pandey |
| Designation |
Junior Resident |
| Affiliation |
Heritage Institute Of Medical Sciences , Varanasi |
| Address |
Heritage Institute Of Medical Sciences, Department Of Anaesthesiology, 4th floor, NH-2 Bypass road ,Bhadwar , Varanasi
Varanasi
UTTAR PRADESH
221311
India |
| Phone |
9953614454 |
| Fax |
|
| Email |
shilpipandey9434@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pushkar Ranjan |
| Designation |
Professor,Dept of Anaesthesiology |
| Affiliation |
Heritage Institute of Medical Sciences |
| Address |
Heritage Institute of Medical Sciences, Department of Anaesthesiology ,NH-2 Bypass, Bhadwar, Varanasi
Uttar Pradesh
Varanasi
UTTAR PRADESH
221311
India |
| Phone |
9415986684 |
| Fax |
|
| Email |
pushkarranjanbhu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pragya Shukla |
| Designation |
Assistant Professor, Dept of Anesthesiology |
| Affiliation |
Heritage Institute of Medical Sciences ,Varanasi |
| Address |
Heritage Institute of Medical Sciences , Department of Anaesthesiology,NH-2 Bypass , Bhadwar , Varanasi
Varanasi
UTTAR PRADESH
221311
India |
| Phone |
9637233147 |
| Fax |
|
| Email |
shuklapragya0509@gmail.com |
|
|
Source of Monetary or Material Support
|
| Heritage Institute of Medical Sciences , NH-2(GT Bypass Road) , Bhadwar , Varanasi, 221311 , Uttar Pradesh , India |
|
|
Primary Sponsor
|
| Name |
Heritage Institute Of Medical Sciences |
| Address |
Heritage Institute of Medical Sciences,NH-2 Bypass, Bhadwar, Varanasi ,221311 , Uttar Pradesh, India |
| 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 |
| Dr Shilpi Pandey |
Heritage Institute Of Medical Sciences |
Department of Anaesthesiology, OT Complex, OT Room no.5,
4th Floor , Heritage Institute Of Medical Sciences ,NH 2 GT Road
Heritage Institute of Medical Sciences
Varanasi
UTTAR PRADESH |
09953614454
shilpipandey9434@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
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 |
| Comparator Agent |
Bupivacaine heavy |
To compare the duration of analgesia between ropivacaine and bupivacaine and also to compare onset and duration of sensory and motor block, hemodynamic changes and side effects in both the groups during 1 hour of surgery |
| Intervention |
Ropivacaine heavy |
Lower back of patients will be painted with betadine and surgical spirit. Sterile drapes will be placed. A 25 gauge Quincke’s needle will be inserted at the level of L3L4 . An hyperbaric 10mg 0.5% Ropivacaine or 0.5% Bupivacaine would be injected only once intrathecal through spinal needle by the Anaesthesiologist not involved in the study |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Pregnancy (over 37 weeks and less than 42weeks) |
|
| ExclusionCriteria |
| Details |
Patients refusal
Infection at the site of injection
Coagulopathy or any other bleeding diathesis
Increased intracranial pressure
Known case of any hypersensitive reactions to local anaesthetics |
|
|
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 the duration of analgesia between Ropivacaine and Bupivacaine in intrathecal anaesthesia |
Every 15 minutes during intra operative |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the onset & duration of sensory & motor block , hemodynamic changes & side effects in both the groups |
Every 15 minutes till 3 hours & then every 30 mins till 12 hours |
|
|
Target Sample Size
|
Total Sample Size="132"
Sample Size from India="132"
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)
|
30/01/2025 |
| 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 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
|
This study is designed to compare the duration of analgesia between Ropivacaine and Bupivacaine intrathecal anaesthesia and also to compare the onset and duration of sensory and motor block, hemodynamic changes and the side effects in both groups |