| CTRI Number |
CTRI/2023/06/053720 [Registered on: 09/06/2023] Trial Registered Prospectively |
| Last Modified On: |
08/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare two drugs hyperbaric levobupivacaine and hyperbaric bupivacaine for cesarean section |
|
Scientific Title of Study
|
TO COMPARE THE EFFICACY OF INTRATHECAL HYPERBARIC LEVOBUPIVACAINE VERSUS HYPERBARIC BUPIVACAINE IN PATIENTS UNDERGOING ELECTIVE LOWER SEGMENT CAESAREAN SECTION |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrReena Makhni |
| Designation |
Associate professor |
| Affiliation |
Government medical college amritsar |
| Address |
Department of anesthesiology and intensive care
Government medical college
Amritsar
Punjab
143001
India
Amritsar
PUNJAB
Amritsar
India |
| Phone |
9814063758 |
| Fax |
|
| Email |
reenamakhni22@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
DrReena Makhni |
| Designation |
Associate professor |
| Affiliation |
Government medical college amritsar |
| Address |
Department of anesthesiology and intensive care
Government medical college
Amritsar
Punjab
143001
India
Amritsar
PUNJAB
Amritsar
India |
| Phone |
9814063758 |
| Fax |
|
| Email |
reenamakhni22@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
DrReena Makhni |
| Designation |
Associate professor |
| Affiliation |
Government medical college amritsar |
| Address |
Department of anesthesiology and intensive care
Government medical college
Amritsar
Punjab
143001
India
Amritsar
PUNJAB
Amritsar
India |
| Phone |
9814063758 |
| Fax |
|
| Email |
reenamakhni22@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Government medical college
Amritsar |
|
|
Primary Sponsor
|
| Name |
Dr Reena makhni |
| Address |
Government medical college amritsar
Department of anesthesiology and intensive care
Circular road amritsar
Punjab
143001
India |
| Type of Sponsor |
Other [] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr kamal Jyoti kashyap |
Government medical college amritsar circular road amritsar Punjab 143001 india |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Bommakanti Nandini |
Government medical college |
Department of anaesthesia, gynec ot complex,8th floor,government medical college amritsar
Amritsar
PUNJAB |
8309873495
nandinidevi.100@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
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 |
| Comparator Agent |
Intrathecal block |
We will give hyperbaric bupivacaine in intrathecal space for caesarean section, 12mg,and various parameters will be noted and compared for 60 mins with other groups |
| Intervention |
Intrathecal block |
We will give hyperbaric levobupivacaine in intrathecal space for caesarean section ,12mg,and various parameters will be noted and compared for 60mins with other groups |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Age group between 18-40years of female sex,ASA grade 2 pregnant patients at term undergoing caesarean section with normal neurological status and cooperative patients |
|
| ExclusionCriteria |
| Details |
Patients refusal for written consent for spinal anaesthesia,any neurological disorder,any coagulation disorder, allergy to study drug, history of any coexisting diseases like IHD,impaired renal functions, rheumatoid arthritis,severe liver disease and also contraindications to regional anaesthesia |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Onset & duration of sensory and motor blockade
Hemodynamic changes |
Onset & duration of sensory and motor blockade for 6 hours post op and haemodynamic parameters for 24 hrs.
Hemodynamic changes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Adverse effects like nausea, vomiting, pruritis, shivering, sedation.
To assess the quality of intramuscular muscle relaxation.
Time for first rescue analgesic requirements
Total number of rescue analgesia |
Time from start of procedure till 24hours post surgery |
|
|
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
19/06/2023 |
| 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="0"
Months="7"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Regional anaesthesia for caesarean section has several advantages over general anaesthesia as it minimise side effects and complications as well as there is less interference with normal metabolic processes and vital functions. The present study will be conducted in department of anesthesiology and intensive care government medical college amritsar after approval from the institutinal thesis and ethics committee.the primary objective of this study will be to assess the onset and duration of sensory and motor blockade and also any haemodynamic changes associated with use of study drugs. |