| CTRI Number |
CTRI/2024/02/063340 [Registered on: 29/02/2024] Trial Registered Prospectively |
| Last Modified On: |
21/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the efficacy of bupivacaine and levobupivacaine in spinal anaesthesia for elective caesarean section |
|
Scientific Title of Study
|
Comparison of efficacy of intrathecal bupivacaine heavy (0.5%) and levobupivacaine heavy (0.5%) for elective caesarean section |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anagha V Harlapur |
| Designation |
Junior resident -3 |
| Affiliation |
BJGMC and Sassoon hospital |
| Address |
BJGMC and Sassoon hospital, Department of Anaesthesia, Room number 11
Pune
MAHARASHTRA
411001
India |
| Phone |
07337857322 |
| Fax |
|
| Email |
anaghavh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Surekha Shinde |
| Designation |
Professor |
| Affiliation |
BJGMC and Sassoon hospital |
| Address |
BJGMC and Sassoon hospital, Department of Anaesthesia
Pune
MAHARASHTRA
411001
India |
| Phone |
07337857322 |
| Fax |
|
| Email |
sureshinde@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anagha V Harlapur |
| Designation |
Junior resident -3 |
| Affiliation |
BJGMC and Sassoon hospital |
| Address |
BJGMC and Sassoon hospital, Department of Anaesthesia, Room number 11
Pune
MAHARASHTRA
411001
India |
| Phone |
07337857322 |
| Fax |
|
| Email |
anaghavh@gmail.com |
|
|
Source of Monetary or Material Support
|
| BJGMC and Sassoon hospital, Jai Prakash Narayan road, Pune station road, Maharashtra 411001 |
|
|
Primary Sponsor
|
| Name |
Anagha V Harlapur |
| Address |
Lateral hostel room number 426, BJGMC and Sassoon hospital, opposite to Bank of baroda pune- 411001 |
| 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 Anagha V Harlapur |
BJGMC and Sassoon hospital |
Department of Anaesthesia, Room number 11
Pune
MAHARASHTRA |
7337857322
anaghavh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee B J government medical college and Sassoon general hospital Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Pregnant women of ASA grade 2 |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Spinal anaesthesia |
Bupivacaine heavy (0.5%) is given intrathecally to induce spinal anaesthesia and levobupivacaine heavy (0.5%) is also given intrathecally and the effects are compared . Duration is half an hour. |
| Comparator Agent |
Spinal anaesthesia |
Comparison between bupivacaine heavy (0.5%) and levobupivacaine heavy (0.5%) in spinal anaesthesia for elective caesarean section. Both are local anaesthetic agents used intrathecally . Duration is half an hour. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Female |
| Details |
Age 18-30 years
ASA grading I and II
Elective caesarean section surgical section |
|
| ExclusionCriteria |
| Details |
Patient who refused to give consent.
A Documented sensitivity to drug in the past.
Bleeding diathesis and coagulopathy.
Age less than 18 and more than 30.
ASA grading III and IV.
Patient on anti hypertensive, anxiolytics, and anti epileptic.
Morbidly obese.
Patients for emergency lscs.
Patients with neurological and psychiatric illness.
Patients with spinal deformity.
Local site infections.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
The onset of action
Duration of sensory blockade
Duration of motor blockade
Quality of anaesthesia
Hemodynamic alterations
Adverse effects |
Measured for half an hour every five minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Pruritus
Sedation
Respiratory depression |
Half an hour for every 5 minutes |
|
|
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 4 |
|
Date of First Enrollment (India)
|
04/03/2024 |
| 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="5"
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
|
Bupivacaine is the most commonly used drug for spinal anaesthesia. Plain Bupivacaine is hypobaric compared to CSF and is made heavy by addition of 8% glucose. It is known to cause hypotension, bradycardia even sudden cardiac death. Levobupivacaine is pure enantiomer of bupivacaine and is truly isobaric with CSF of pregnant women. It causes less cardiotoxicity and is more specific for sensory blockade than motor blockade. |