| CTRI Number |
CTRI/2024/02/062839 [Registered on: 19/02/2024] Trial Registered Prospectively |
| Last Modified On: |
17/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Better drug amongst Hyperbaric Ropivacaine and Hyperbaric Bupivacaine in Cesarean Section for Spinal Anaesthesia |
|
Scientific Title of Study
|
The efficacy of Hyperbaric Ropivacaine and Hyperbaric Bupivacaine in cesarean section for Spinal anaesthesia at Rural Tertiary Care Hospital,Loni,Maharashtra. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Chiranshi Shah |
| Designation |
3rd year Junior resident Anaesthesiology |
| Affiliation |
Pravara institute of medical sciences, Loni |
| Address |
RMO ladies hostel, PMT , Pravara Institute of Medical Sciences
Loni, Bk ,Rahata,Ahmadnagar
RMO ladies hostel, PMT , Pravara Institute of Medical Sciences,
Loni, BK ,Rahata,Ahmadnagar
Ahmadnagar
MAHARASHTRA
413736
India |
| Phone |
7498905244 |
| Fax |
|
| Email |
chiranshi97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tushar D Bhavar |
| Designation |
Professor |
| Affiliation |
Pravara institute of medical sciences, Loni |
| Address |
Department of Anaesthesiology, Pravara Institute of Medical Sciences,
Loni, BK ,Rahata,Ahmadnagar
Department of Anaesthesiology, Pravara Institute of Medical Sciences,
Loni, BK ,Rahata,Ahmadnagar
Ahmadnagar
MAHARASHTRA
413736
India |
| Phone |
7745084105 |
| Fax |
|
| Email |
tganesh55555@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Chiranshi Shah |
| Designation |
3rd year Junior resident Anaesthesiology |
| Affiliation |
Pravara institute of medical sciences, Loni |
| Address |
RMO ladies hostel, PMT , Pravara Institute of Medical Sciences
Loni, Bk ,Rahata,Ahmadnagar
RMO ladies hostel, PMT , Pravara Institute of Medical Sciences
Loni, Bk ,Rahata,Ahmadnagar
Ahmadnagar
MAHARASHTRA
413736
India |
| Phone |
7498905244 |
| Fax |
|
| Email |
chiranshi97@gmail.com |
|
|
Source of Monetary or Material Support
|
| New OT Complex,Dr Vitthalrao Vikhe Patil,Pravara Rural Hospital,Pravara Institute Of Medical Sciences, Loni, Ahmadnagar |
|
|
Primary Sponsor
|
| Name |
DBVPRMC Dr Balasaheb Vikhe Patil Rural Medical College |
| Address |
Loni Bk maharashtra india |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Tushar Bhavar |
Dr Vitthalrao Vikhe Patil, Pravara Rural Hospital, Loni, Ahmadnagar |
New OT Complex, Department of Anaesthesiology,Pravara Institute of Medical Sciences ,Loni, Bk, Ahmadnagar
Ahmadnagar
MAHARASHTRA |
7745084105
tganesh55555@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE Pravara Institute of Medical Sciences- Deemed University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
posted for cesarean section |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1.Belonging to ASA grade2
2.Patients receiving spinal anaesthesia with either ropivacaine or bupivacaine
3.Willing to give informed and verbal consent to participate in the study |
|
| ExclusionCriteria |
| Details |
1 Patients contraindicated for spinal anaesthesia
2 Gestational diabetes mellitus
3 Cardiac disorders
4 Fetal distress
5 Pregnancy induced hypertension
6 Cord prolapse
7 Placenta previa
8 Antepartum hemorrhage |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate and compare analgesic effect of hyperbaric ropivacaine and hyperbaric bupivacaine for regression to L5 level |
300mins |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To study the onset and duration of motor block of hyperbaric ropivacaine and hyperbaric bupivacaine
2. To study the variations in hemodynamic parameters |
300mins |
|
|
Target Sample Size
|
Total Sample Size="280"
Sample Size from India="280"
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)
|
28/02/2024 |
| 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) |
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
|
- To compare the efficacy of hyperbaric ropivacaine and hyperbaric bupivacaine in cesarean section for spinal anaesthesia at Rural Tertiary Care Hospital
- To evaluate and compare analgesic effect of hyperbaric ropivacaine and hyperbaric bupivacaine for regression to L5 level
To study the onset and duration of motor block of hyperbaric ropivacaine and hyperbaric bupivacaine To study the variations in hemodynamic parameters To know about patients’ and surgeon satisfaction
|
