| CTRI Number |
CTRI/2022/10/046717 [Registered on: 21/10/2022] Trial Registered Prospectively |
| Last Modified On: |
16/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of ropivacaine and bupivacaine for spinal anaesthesia. |
|
Scientific Title of Study
|
Comparison of 0.75% hyperbaric ropivacaine versus 0.5% hyperbaric bupivacaine in spinal anaesthesia for elective surgery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pragati Volvoikar |
| Designation |
DNB Trainee |
| Affiliation |
Bhabha Atomic Research Centre |
| Address |
Department of Anaesthesiology, BARC hospital,Anushaktinagar, Mumbai.
Mumbai
MAHARASHTRA
400094
India |
| Phone |
9823136851 |
| Fax |
|
| Email |
pragati3370@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shrividhya Chellam |
| Designation |
Consultant Anaesthesiology |
| Affiliation |
Bhabha Atomic Research Centre |
| Address |
Department of Anaesthesiology, BARC hospital,Anushaktinagar, Mumbai.
Mumbai (Suburban)
MAHARASHTRA
400094
India |
| Phone |
9521354101 |
| Fax |
|
| Email |
shrivic@barc.gov.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pragati Volvoikar |
| Designation |
DNB Trainee |
| Affiliation |
Bhabha Atomic Research Centre |
| Address |
Department of Anaesthesiology, BARC hospital,Anushaktinagar, Mumbai.
Mumbai (Suburban)
MAHARASHTRA
400094
India |
| Phone |
9823136851 |
| Fax |
|
| Email |
pragati3370@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Bhabha Atomic Research Centre |
| Address |
Department of Anaesthesiology, BARC hospital,Anushaktinagar, Mumbai. |
| Type of Sponsor |
Other [DNB Training Central Government 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 Pragati Volvoikar |
BARC Hospital |
2nd floor, main operation theatre, Department Of Anaesthesiology, BARC Hospital, Anushaktinagar, Mumbai.
Mumbai
MAHARASHTRA |
9823136851
pragati3370@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BARC Hospital Medical Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
0.5 % hyperbaric Bupivacaine |
Patients will be divided into two groups. Group 1 – 3ml hyperbaric 0.75% ropivacaine Group 2- 3ml hyperbaric 0.5% bupivacaine Patients will be randomly divided into two groups which will be slip in the box method. group 2 will be compared with group 1 for parameters as mentioned in details. |
| Comparator Agent |
0.75% hyperbaric ropivacaine |
Patients will be divided into two groups.
Group 1 – 3ml hyperbaric 0.75% ropivacaine Group 2- 3ml hyperbaric 0.5% bupivacaine
Patients will be randomly divided into two groups which will be slip in the box method. Patients monitoring for Systolic Blood Pressure, Diastolic Blood Pressure, Mean Arterial Pressure, heart rate, SpO2 along with level of sensory and motor blockade will be assessed.
Time taken for maximum sensory block along with level will be assessed by checking loss of cold sensation using ether swab.time taken for maximum motor blockade along with level will be assessed by Modified Bromage Scale. From above data time taken for achieving The total duration of spinal anaesthesia will be measured from 0 minute till 5 segment sensory regression or modified bromage 1 whichever is earlier. Any episode of hypotension or bradycardia will be noted.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged 18-60 years, ASA grade I-II undergoing elective infra-umbilical surgeries, less than 2hours, under spinal anaesthesia. |
|
| ExclusionCriteria |
| Details |
Patient refusal
Pregnancy
Allergy to local anesthetic drugs
Any other contra indications to spinal anaesthesia
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study duration of action of hyperbaric ropivacaine and hyperbaric bupivacaine. |
24hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study
1.Time taken to achieve maximum sensory blockade.
2.Time taken to achieve maximum motor blockade.
3.Intra-operative hemodynamics.
4.Time taken for 5 segment regression of sensory block.
5.Time taken for regression of motor blockade to modified Bromage 1.
6.Side effects if any
|
24hours |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
27/10/2022 |
| Date of Study Completion (India) |
07/08/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
50 Patients posted for elective infra-umbilical procedures will be grouped into 2 groups, Ropivacaine(25) versus Bupivacaine(25). Spinal anaesthesia will be performed and the following parameters will be studied. Time taken to achieve maximum Sensory block. Time taken to achieve Complete Motor block. Intra-operative Hemodynamics. Time taken for 5 segment regression of sensory block. Time taken for regression of Motor block to Modified Bromage 1. Side effects. |