| CTRI Number |
CTRI/2024/01/061890 [Registered on: 29/01/2024] Trial Registered Prospectively |
| Last Modified On: |
19/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of two local anesthetics for spinal anesthesia in caesarean section |
|
Scientific Title of Study
|
Comparison of Clinical Efficacy and Safety Profile of Hyperbaric Ropivacaine 0.75% and Hyperbaric Bupivacaine 0.5% in Spinal Anesthesia for Patients Posted for Elective Caesarean Section: An Observational Study in A Tertiary Care Hospital in Mandya. |
| 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 Shivakumar G |
| Designation |
Professor and HoD |
| Affiliation |
MANDYA INSTITUTE OF MEDICAL SCIENCES |
| Address |
Department of Anaesthesia,
Mandya institute of medical sciences,
Mandya,
Karnataka.
Mandya
KARNATAKA
571401
India |
| Phone |
9900468451 |
| Fax |
|
| Email |
dranashiv@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shivakumar G |
| Designation |
Professor and HoD |
| Affiliation |
MANDYA INSTITUTE OF MEDICAL SCIENCES |
| Address |
Department of Anaesthesia,
Mandya institute of medical sciences,
Mandya
Mandya
KARNATAKA
571401
India |
| Phone |
9900468451 |
| Fax |
|
| Email |
dranashiv@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shivakumar G |
| Designation |
Professor and HoD |
| Affiliation |
MANDYA INSTITUTE OF MEDICAL SCIENCES |
| Address |
Department of Anaesthesia,
Mandya institute of medical sciences,
Mandya
Mandya
KARNATAKA
571401
India |
| Phone |
9900468451 |
| Fax |
|
| Email |
dranashiv@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mandya institute of medical sciences. |
|
|
Primary Sponsor
|
| Name |
Dr Shivakumar G |
| Address |
Professor and HoD,
Department of Anaesthesia,
Mandya institute of medical sciences,
Mandya,
Karnataka. |
| Type of Sponsor |
Government 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 ASWIN M ULLAS |
MANDYA INSTITUTE OF MEDICAL SCIENCES |
Department of Anaesthesia
First floor
Mandya institute of medical sciences
Mandya
KARNATAKA |
9400864833
aswinmullas@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTION ETHICS COMMITTEE MANDYA INSTITUTE OF MEDICAL SCIENCES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O94||Sequelae of complication of pregnancy, childbirth, and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Bupivacaine 0.5% 2 ml |
Clinical efficacy and safety profile of bupivacaine 0.5% 2 ml in elective caesarean section. |
| Intervention |
Ropivacaine 0.75% 2 ml |
Clinical efficacy and safety profile if ropivacaine 0.75% 2 cc in elective caesarean section. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Patients posted for elective caesarean section surgeries.
Age group 18 to 40 years.
Patients with height 150cm-180cm and weight 40kg-80kg.
Patients with American Society of Anaesthesiologists-Physical status (ASA-PS) grade I and II.
Patients willing to give informed consent to participate in the study. |
|
| ExclusionCriteria |
| Details |
Patients with cardiovascular diseases or pregnancy induced hypertension and gestational diabetes mellitus.
Patients having increased intracranial tension, severe hypovolemia, history of bleeding diathesis and local infection. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparing the onset and duration of sensory and motor blockade. |
24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the anaesthetic profile and effects of intrathecal hyperbaric ropivacaine 0.75% and hyperbaric bupivacaine 0.5% in spinal anaesthesia for elective caesarean section by using the following parameters:
1.Intraoperative hemodynamic parameters.
2.Duration of analgesia (until first dose of analgesia demand).
3.Adverse effects.
|
UPTO 24 HOURS |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
01/02/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study aims in comparing the anaesthetic profile and effects of intrathecal hyperbaric ropivacaine 0.75% and hyperbaric bupivacaine 0.5% in spinal anaesthesia for elective caesarean section in a group of 80 people by using the following parameters:
Primary objectives: 1. Onset and duration of sensory blockade (T6 dermatome). 2. Onset and duration of motor blockade.
Secondary objectives: 1.Intraoperative hemodynamic parameters. 2.Duration of analgesia (until first dose of analgesia demand). 3.Adverse effects. |