| CTRI Number |
CTRI/2025/02/080677 [Registered on: 17/02/2025] Trial Registered Prospectively |
| Last Modified On: |
19/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Better drug for Caesarean section |
|
Scientific Title of Study
|
Comparative study of hyperbaric ropivacaine vs hyperbaric levobupivacaine for spinal anesthesia in Caesarean section : A prospective randomized double blind clinical study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sreenidhi Shukla |
| Designation |
Post Graduate Resident |
| Affiliation |
Government Medical College, Baroda |
| Address |
Department of Anaesthesiology, government medical college, Baroda
SSG Hospital, Anandpura, Vadodara
GUJARAT
India
Vadodara
GUJARAT
390001
India |
| Phone |
8978229071 |
| Fax |
|
| Email |
sreenidhishukla@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yogita Patel |
| Designation |
Assistant Professor |
| Affiliation |
Government Medical College, Baroda |
| Address |
Department of Anaesthesiology, Government Medical College, Baroda, Vadodara
GUJARAT
390001
India
Vadodara
GUJARAT
390001
India |
| Phone |
9023449878 |
| Fax |
|
| Email |
yogi.80patel@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yogita Patel |
| Designation |
Assistant Professor |
| Affiliation |
Government Medical College, Baroda |
| Address |
Department of Anaesthesiology, Government Medical College, Baroda, Vadodara
GUJARAT
390001
India
Vadodara
GUJARAT
390001
India |
| Phone |
9023449878 |
| Fax |
|
| Email |
yogi.80patel@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, Government Medical College,SSG Hospital,Baroda, 390001 Vadodara, Gujarat, India |
|
|
Primary Sponsor
|
| Name |
Government medical College Baroda |
| Address |
Department of Anaesthesiology, Government Medical College, SSG Hospital,Baroda, Vadodara 390001, Gujarat, India |
| 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 Sreenidhi Shukla |
SSG Hospital |
Department of Anaesthesiology, Government Medical College and SSG Hospital, Baroda
Vadodara
GUJARAT |
8978229071
sreenidhishukla@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Biomedical and Health Research (IECBHR) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 1||Obstetrics, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
LEVOBUPIVACAINE |
2mL of 0.5% injection levobupivacaine heavy will be used for spinal anaesthesia in Caesarean section |
| Intervention |
ROPIVACAINE |
In elective Caesarean Section 2mL of 0.75% Ropivacaine used for Intrathecal Anaesthesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1. 18-40 years
2. ASA physical status 2
3. Elective Caesarean Section
4. Singleton Full Term Pregnancy |
|
| ExclusionCriteria |
| Details |
1. Patient refusal
2. Patient on anti coagulant therapy
3. Patient with local site infection
4. Patient with allergy to local anesthetics
5. Increased Intra cranial pressure
6. Severe hypovolemia
7. Severe intraoperative blood loss expected
8. Height less than or equal to 150 centimetres
9. BMI greater than or equal to 30 |
|
|
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 |
| Pulse rate in both the groups will be compared |
before spinal anesthesia, immediately after spinal anestheia, every 5 minutes for the first half hour and every 15 minutes for the rest of the surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Time required to reach sensory block up to T6
2. Time required to reach Maximum (peak) level of sensory block
3. Time required for two segment regression of block from the peak level
4. Time required for complete regression of sensory block
5. Time required to achieve complete motor block as assessed by modified Bromage scale 3
6. Time required to achieve complete recovery of motor block as assessed by modified Bromage scale 3 |
Sensory and motor block characteristics measured every 10 seconds till patient reaches maximum sensory or motor block and for every 30 seconds thereafter |
|
|
Target Sample Size
|
Total Sample Size="116"
Sample Size from India="116"
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)
|
01/03/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
IJCA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Generally, spinal anaesthesia is performed with hyperbaric racemic bupivacaine. Levobupivacaine and Ropivacaine are two new long acting local anesthetics ( pure S enantiomers of bupivacaine) that have been developed as an alternative to bupivacaine after evidence of its severe toxicity. In the present study, we would like to compare the hemodynamic stability and block characteristics of two pure S enantiomers of bupivacaine - hyperbaric Levobupivacaine (0.5%) and hyperbaric ropivacaine (0.75%) in patients undergoing elective Caesarean Section |