| CTRI Number |
CTRI/2025/07/090208 [Registered on: 04/07/2025] Trial Registered Prospectively |
| Last Modified On: |
03/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Safety and efficacy of intrathecal hyperbaric Ropivacaine vs Bupivacaine in elective lower segment caesarean section. |
|
Scientific Title of Study
|
Safety and efficacy of intrathecal hyperbaric Ropivacaine 0.75 percent vs Bupivacaine 0.5 percent in elective lower segment caesarean section A prospective randomised study |
| 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 Surekha patil |
| Designation |
Professor |
| Affiliation |
D Y Patil Hospital |
| Address |
second floor A block department of anaesthesia D Y Patil hospital ayappa temple rd sector 5 Nerul Navi Mumbai Maharashtra 400706
Thane
MAHARASHTRA
400706
India |
| Phone |
9930923108 |
| Fax |
|
| Email |
surekha.patil@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Surekha patil |
| Designation |
professor |
| Affiliation |
D Y Patil Hospital |
| Address |
second floor A block department of anaesthesia D Y Patil hospital ayappa temple rd sector 5 Nerul Navi Mumbai Maharashtra 400706
Thane
MAHARASHTRA
400706
India |
| Phone |
9930923108 |
| Fax |
|
| Email |
surekha.patil@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pulla Sharath Chandra |
| Designation |
Junior resident |
| Affiliation |
D Y Patil Hospital |
| Address |
second floor A block department of anaesthesia D Y Patil hospital ayappa temple rd sector 5 Nerul Navi Mumbai Maharashtra 400706
Thane
MAHARASHTRA
400706
India |
| Phone |
8790626506 |
| Fax |
|
| Email |
sharathchandra8790@gmail.com |
|
|
Source of Monetary or Material Support
|
| D Y Patil Hospital,Sector 5 Nerul, Navi Mumbai,400706, INDIA |
|
|
Primary Sponsor
|
| Name |
D Y Patil Hospital |
| Address |
Second floor, A Block Department of Anaesthesia D Y Patil hospital Ayyappa temple road, sector 5, Nerul, Navi Mumbai 400706, 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 Pulla Sharath Chandra |
D Y Patil hospital |
Second floor, A Block Department of Anaesthesia D Y Patil hospital Ayyappa Temple road, sector 5, Nerul , Navi Mumbai 400706
Thane
MAHARASHTRA |
8790626506
sharathchandra8790@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for biomedical and Health Research, D. Y. Patil Deemed to be University School of Medicine, Navi-Mumbai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 1||Obstetrics, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Hyperbaric Bupivacaine 0.5 percent |
Spinal drug Hyperbaric Bupivacaine 0.5 percent in elective lower segment caesarean sections. Pulse rate and Blood pressure measured at time intervals - Baseline and every 2 minutes till 30 minutes then every 10 minutes till the end of surgery. Motor and sensory blockade also assessed. |
| Comparator Agent |
Hyperbaric Ropivacaine 0.75 percent. |
Spinal drug hyperbaric ropivacaine 0.75 percent in elective lower segment caesarean sections. Pulse rate and Blood pressure measured at time intervals - Baseline and every 2 minutes till 30 minutes then every 10 minutes till the end of surgery. Motor and sensory blockade also assessed. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
ASA grade 2
Gestational age between 37 to 42 weeks
Giving consent |
|
| ExclusionCriteria |
| Details |
Patient height less than 150cms
Spinal deformity
Allergy to drug
ASA grade3 and above
Refused for consent |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of ropivacaine and bupivacaine on hemodynamic changes in pregnant patients undergoing caesarean section. |
Baseline and every 2 minutes till 30 minutes then every 10 minutes till the end of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To measure the onset of sensory and motor block and duration of sensory and motor blockade |
Baseline and every 2 minutes till 30 minutes then every 10 minutes till the end of surgery |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
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 4 |
|
Date of First Enrollment (India)
|
31/07/2025 |
| 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
|
Spinal Anaesthesia with drug hyperbaric ropivacaine 0.75 percent and hyperbaric bupivacaine 0.5 percent in pregnant patient undergoing elective caesarean sections will be used. hemodynamic parameters like blood pressure and pulse rate will be assessed at every 2 minute interval till 30 minutes and then every 10 minutes till the end of surgery to compare both the drugs. Sensory and Motor blockade will also be assessed with Bromage’s scale at same time intervals. |