| CTRI Number |
CTRI/2023/03/051045 [Registered on: 24/03/2023] Trial Registered Prospectively |
| Last Modified On: |
24/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Clinical to compare the effects of two drugs hyperbaric Bupivacaine and hyperbaric Ropivacaine in caesarean section under Spinal Anaesthesia. |
|
Scientific Title of Study
|
Comparing the effect of hyperbaric Bupivacaine with hyperbaric Ropivacaine on the block characteristics in parturient undergoing caesarean section under spinal anaesthesia:A randomised double blinded study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| A/206/REB-Comm(SP)/RIMS/2015/903/241/2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MILLO TAMA |
| Designation |
Post Graduate Trainee |
| Affiliation |
Manipur University |
| Address |
Department Of Anaesthesia
Regional Institute Of Medical Sciences
Imphal
Manipur
Imphal West
MANIPUR
795004
India |
| Phone |
8974354454 |
| Fax |
|
| Email |
mitma1454@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
MILLO TAMA |
| Designation |
Post Graduate Trainee |
| Affiliation |
Manipur University |
| Address |
Department Of Anaesthesia
Regional Institute Of Medical Sciences
Imphal
Manipur
MANIPUR
795004
India |
| Phone |
8974354454 |
| Fax |
|
| Email |
mitma1454@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr A Jack Meitei |
| Designation |
Assistant Professor |
| Affiliation |
Manipur University |
| Address |
Department Of Anaesthesia
Regional Institute Of Medical Sciences
Imphal
Manipur
Imphal West
MANIPUR
795004
India |
| Phone |
9774262996 |
| Fax |
|
| Email |
jack2k49@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Anaesthesiology,Regional Institute Of Medical Sciences,Imphal,Manipur |
|
|
Primary Sponsor
|
| Name |
Dr Millo Tama |
| Address |
Regional Institute Of Medical Sciences,Imphal |
| Type of Sponsor |
Other [Post Graduate Trainee] |
|
|
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 Millo Tama |
Regional Institute Of Medical Sciences,Imphal,Manipur |
Elective Surgery Modular Operation Theatre Complex (OT2),Department Of Anaesthesiology,Regional Institute Of Medical Science
Imphal West
MANIPUR |
8974354454
mitma1454@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research Ethics Board, Regional Institute of Medical Sciences,Imphal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
ICD-10-CM 082 |
| Patients |
(1) ICD-10 Condition: 1||Obstetrics, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Hyperbaric Bupivacaine |
Study participants will be randomised into 2 groups Comparator group will receive 2 ml of 0.5% Hyperbaric Bupivacaine intrathecally for spinal anaesthesia. |
| Intervention |
Hyperbaric Ropivacaine |
Study participants will be randomised into two groups.Intervention group will receive the 2 ml of 0.5% of hyperbaric intrathecally for spinal anaesthesia. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
ASA I or ASA II
term Pregnant woman |
|
| ExclusionCriteria |
| Details |
a. History of allergy to study drugs
b. Bleeding disorder-platelet count <50,000/micro litre, prothrombin time>14 sec International normalised ratio(INR)->1.5
c. Local site infection
d. Cardiac, respiratory diseases and kidney disorder, neurological deficit
e. Spinal deformity
|
|
|
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 |
1.The block characteristics
2.regression of the blockade
3.side effects (if any)
4.hemodynamic changes |
outcome will be assesed after the administration of local anaesthetic at predetermined interval and data will be assesed at the end of the year. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.BP,PR,
2.Onset sensory block 10
3.Time to attain T4-6
4.Time to two segment regression
5.Total duration Sensory block
6.Onset Motor block
7.Time to Complete Motor block
8.Time to rescue Analgesia
9.Side effects if any |
1.0,10,15,20,30,40,50,60(mt)
2.Assesed and recorded after spinal every 2 minutes till 10 Sensory block
3.Assesed and recorded after spinal every 2 minute till T4-6 level reached
7.Assesed and recorded as per bromage scale till complete block 2 minutes after spinal
8.Noted as per symptoms of patient
9.Note time if any side effects as per symptoms 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)
|
27/03/2023 |
| 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
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A major problem with Spinal Anaesthesia is that the use of local anaesthetics has ocassionally associated with adverse cardiac and neurotoxic side effects requiring early intervention in the early intraoperative period. The study will be prospective randomised double blinded study to asses and compare the effects of intrathecal administration of low dose 0.5% (2ml) hyperbaric bupivacaine versus 0.5% (2ml) hyperbaric ropivacaine in parturients undergoing LSCS under subarachnoid block.. A total of 60 parturient will be selected for the study and divided into two groups of 30 patients each like Group A (n=30) and Group B (n=30). According to a computer generated randomised table,patients in group A will be administered 2 ml of 0.5% bupivacaine heavy and group B will be administered 2 ml of 0.5% ropivacaine heavy in the subarachnoid space L3-L4.The block characteristic alongwith regression of the blockade,side effects (if any) and the haemodynamic changes will be observed,assesed and recorded by blind investigator using the VAS,Modified Bromage Scale. The data obtained will be collected and analysed using student ’t’ test for continous data and Chi square test forcategorical data as and where appropriate.
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