| CTRI Number |
CTRI/2025/04/085023 [Registered on: 17/04/2025] Trial Registered Prospectively |
| Last Modified On: |
16/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Prospective randomised double blind study between the efficacy of intrathecal 0.5% heavy vs isobaric Bupivacaine in elective LSCS. |
|
Scientific Title of Study
|
Prospective Randomized double blind comparitive study between the efficacy of intrathecal 0.5 percent Bupivacaine heavy vs isobaric in elective lscs. |
| 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 kaushik dandanak |
| Designation |
PG student |
| Affiliation |
D.Y Patil school of medicine |
| Address |
A block, department of anaesthesia, D.Y Patil school of medicine,sector 5, nerul,navi mumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
7893042746 |
| Fax |
|
| Email |
kdandanak@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Balasaheb Govardhane |
| Designation |
professor |
| Affiliation |
D.Y Patil school of medicine |
| Address |
A-block, dept. of anaesthesia, D.Y Patil school of medicine,sector 5, nerul,navi mumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
9819631719 |
| Fax |
|
| Email |
gbalasaheb690@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Balasaheb Govardhane |
| Designation |
professor |
| Affiliation |
D.Y Patil school of medicine |
| Address |
A-block, dept. of anaesthesia, D.Y Patil school of medicine,sector 5, nerul,navi mumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
9819631719 |
| Fax |
|
| Email |
gbalasaheb690@gmail.com |
|
|
Source of Monetary or Material Support
|
| DY PATIL HOSPITAL, NAVI MUMBAI |
|
|
Primary Sponsor
|
| Name |
dy patil school of medicine and hospital nerul navi mumbai |
| Address |
A block,Department of Anesthesiology,dy patil school of medicine,sector 5,nerul,navi mumbai. 400706. |
| Type of Sponsor |
Research institution and 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 Kaushik Dandanak |
DY PATIL HOSPITAL |
SECOND FLOOR OT COMPLEX, DY PATIL HOSPITAL, AYYAPPA SWAMI ROAD, NERUL, 400706.
Thane
MAHARASHTRA |
7893042746
kdandanak@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee For Biomedical and Health Research. DY PATIL DEEMED TO BE UNIVERSITY SCHOOL OF MEDICINE,NAVI MUMBAI. |
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 |
Hyperbaric Injection Bupivacaine 0.5 percent |
Hyperbaric Injection Bupivacaine 0.5 percent to be given as drug for spinal anaesthesia in patients undergoing elective lower section cesarean section. |
| Intervention |
Injection Bupivacaine 0.5 percent isobaric. |
Isobaric Injection Bupivacaine 0.5 percent 2.0 ml to be given as drug for spinal anaesthesia in patients undergoing elective lower section cesarean section. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1 All patients giving consent undergoing elective lscs
2 ASA grade 2
3 patients coming for elective c-section with gestational age og greater than 35 weeks
4 height more than 150 cms |
|
| ExclusionCriteria |
| Details |
Patients undergoing emergency C-SECTIONS
1 Patients known or suspected to have allergy for study drugs.
2 Patient refusal
3 Patients with contraindications to spinal anaesthesia. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the anaesthetic properties of isobaric and hyperbaric
bupivacaine in spinal anaesthesia, which includes the time of onset of sensory
and motor block and duration of block obtained (both sensory and motor) |
at base line,2 mins,4 mins, 6 mins, 8 mins, 15 mins, 20 mins, 25 mins, 30 mins, 40 mins, 50 mins, 60 mins |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the effects of both the drugs on haemodynamic
parameters which include heart rate & blood pressure & side effects. |
at 2 minutes,4 minutes,6 minutes, 8 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes, 40 minutes, 50 minutes , 60 minutes after the induction of spinal anaesthesia |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
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 |
|
Date of First Enrollment (India)
|
01/05/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Elective lower segment cesarian section is a commonly performed surgical procedure which requires anaesthesia. Most common mode of anaesthesia used is spinal anaesthesia . The drug commonly used to give spinal anaesthesia in such patients is injection bupivacaine 0.5 percent hyperbaric. This study aims to compare the anaesthetic properties and haemodynamic changes caused by the aforementioned drug to isobaric injection bupivacaine 0.5 and its anaesthetic properties and haemodynamic changes.
Inclusion criteria includes patients undergoing elective cesarian section between the ages of 20 and 40. ASA 2. Height more than 150 cms and gestational age of greater than 35 weeks.
Similarly exclusion criteria involves patients undergoing emergency lower section cesarean section , contraindication or allergy to the above used drugs, contraindication to spinal anaesthesia, patient refusal.
The study will be conducted in dy patil school of medicine and hospital, nerul, navi mumbai. Over a period of 2 years.
The study method is randomised control trial double blind.
Sample size is 48. |