| CTRI Number |
CTRI/2022/04/041908 [Registered on: 19/04/2022] Trial Registered Prospectively |
| Last Modified On: |
13/04/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of two local anaesthetics in spinal anaesthesia |
|
Scientific Title of Study
|
A comparative study of 0.75% ropivacaine heavy versus 0.5% bupivacaine heavy in subarachnoid block for infra umbilical surgeries. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gayathri Ramesh |
| Designation |
Senior Resident |
| Affiliation |
Sree Balaji medical college and hospital |
| Address |
Department of Anaesthesiology
Sree Balaji Medical college and Hospital
Chrompet, Chennai
Kancheepuram
TAMIL NADU
600044
India |
| Phone |
9004645828 |
| Fax |
|
| Email |
docgayu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Gayathri Ramesh |
| Designation |
Senior Resident |
| Affiliation |
Sree Balaji medical college and hospital |
| Address |
Department of Anaesthesiology
Sree Balaji Medical college and Hospital
Chrompet, Chennai
Kancheepuram
TAMIL NADU
600044
India |
| Phone |
9004645828 |
| Fax |
|
| Email |
docgayu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Gayathri Ramesh |
| Designation |
Senior Resident |
| Affiliation |
Sree Balaji medical college and hospital |
| Address |
Department of Anaesthesiology
Sree Balaji Medical college and Hospital
Chrompet, Chennai
Kancheepuram
TAMIL NADU
600044
India |
| Phone |
9004645828 |
| Fax |
|
| Email |
docgayu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sree Balaji Medical College and hospital, Chennai |
|
|
Primary Sponsor
|
| Name |
Sree Balaji Medical College and Hospital |
| Address |
No 7, works road
Chrompet
Chennai 600044 |
| 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 Gayathri Ramesh |
Sree Balaji Medical College and Hospital |
3rd and 4th floor OT complex,
Department of Anaesthesiology
Sree Balaji Medical College and Hospital
no 7 works road, Chrompet
Chennai-600044
Kancheepuram
TAMIL NADU |
9004645828
docgayu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
group 1 (Ropivacaine) |
3.5 ml of 0.75% hyperbaric Ropivacaine will be administered in spinal anaesthesia |
| Comparator Agent |
group 2 (Bupivacaine) |
3.5 ml of 0.5% hyperbaric Bupivacaine will be administered in spinal anaesthesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1&2
Undergoing infra umbilical surgery under subarachnoid block
Consenting to participate in the study |
|
| ExclusionCriteria |
| Details |
Patient refusal
Allergy to local anaesthetics
Local infection at the site of block
Bleeding disorder
Pre operative hypotension
pregnancy
|
|
|
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 |
| onset and duration of sensory block |
The onset of sensory block at T10 will be monitored from positioning the patient after spinal anaesthesia at every 30 seconds and thereafter at every 3 minutes for the 1st 15 minutes and at every 30 minutes till it recedes to S2 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| onset and duration of motor block |
motor block will be monitored from 0 minute at 30 seconds interval till grade 3 block according to modified Bromage scale is achieved and at 30 minutes interval till complete regression of motor block |
| hemodynamic disturbance and complications. |
vital parameters will be monitored from 0 minute at 3 minute interval till 1st 15 minutes, at 10 minutes interval during the surgery and at 30 minutes interval till complete recovery. fall in MAP or SBP more than 30% or heart rate below 50/min requiring pharmacological treatment will be noted and patient followed up for 24 hours to note other complications such as nausea vomiting, rashes, urinary retention if any |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
20/04/2022 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
We are yet to start the study. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
0.75% ropivacaine has equal potency to 0.5% bupivacaine and Ropivacaine has been proven to be safer than Bupivacaine. However, Bupivacaine is still commonly used in our country and readily-available 0.75% hyperbaric ropivacaine has not been studied so far in the Indian population. Hence, we are planning to conduct this study. |