| CTRI Number |
CTRI/2024/12/078329 [Registered on: 19/12/2024] Trial Registered Prospectively |
| Last Modified On: |
07/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of ropivacaine and levobupivacaine for spinal anaesthesia in patients of caesarian section |
|
Scientific Title of Study
|
Comparative evaluvation of spinal anaesthesia with hyperbaric solution of
levobupivacaine and ropivacaine for caesarean section Randomized double-blind controlled 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 |
Dr Mamta Damor |
| Designation |
Associate Professor |
| Affiliation |
Govt. Medical college dungarpur |
| Address |
Department of anaesthesiaGovt medical college dungarpur
Dungarpur
RAJASTHAN
314001
India |
| Phone |
8441896796 |
| Fax |
|
| Email |
mamtadamor123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Vineeta Goda |
| Designation |
Associate Professor |
| Affiliation |
Govt. Medical college dungarpur |
| Address |
Department of anaesthesiaGovt medical college dungarpur
Dungarpur
RAJASTHAN
314001
India |
| Phone |
8441896796 |
| Fax |
|
| Email |
vineeta7goda@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mamta Damor |
| Designation |
Associate Professor |
| Affiliation |
Govt. Medical college dungarpur |
| Address |
Department of anaesthesiaGovt medical college dungarpur
RAJASTHAN
314001
India |
| Phone |
8441896796 |
| Fax |
|
| Email |
mamtadamor123@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anesthesia, medical College, Dungarpur, Rajasthan, India
pin code 314001
|
|
|
Primary Sponsor
|
| Name |
Department of Anesthesia Medical college Dungarpur |
| Address |
Medical college Dungarpur, Rajasthan, India
pin code-314001 |
| 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 Vineeta Goda |
Haridev joshi hospital |
Department of anaesthesia, Obstetrics operation theater,
Haridev joshi hospital, Govt. medical college Dungarpur
Dungarpur
RAJASTHAN |
8441896796
vineeta7goda@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government medical college nd associated grou of hospital dngarpur rajasthan 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 |
| Intervention |
Spinal anaesthesia with either 2ml of 0.5% hyperbaric levobupivacaine or 0.75% hyperbaric ropivacaine |
Spinal anaesthesia is given in the L3-L4 subarachnoid space with a 25G spinal needle in the sitting position. After the free flow of the CSF, the test drug will be delivered, followed by the patients turn to a supine position with left uterine displacement. |
| Comparator Agent |
Spinal anaesthesia with either 2ml of 0.5% hyperbaric levobupivacaine or 0.75% hyperbaric ropivacaine |
To compare the clinical efficacy and safety of an equal volume (2ml) of 0.75% hyperbaric ropivacaine with 0.5 % hyperbaric levobupivacaine for cesarean section under spinal anesthesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
• ASA physical status I and II,
• Age between 18-35 years
• At Term, Elective caesarean Section
• Valid informed consent
• height ranging between 150 – 170 cms
• weight ranging between 50 – 90 kg.
|
|
| ExclusionCriteria |
| Details |
•Pregnant patients having coexisting systemic disorders like neuromuscular diseases, neuronal degenerative disorder, seizure disorder, bleeding and haematological disorders, Cardiac disorders, Diabetes mellitus or gestational diabetes.
• Pregnant women with hepatic and renal disorders, severe Anaemia
• Eclampsia, placenta previa, abruptio placenta
• Parturient in active labour, Twin/ complicated pregnancy
• Spinal deformities, poliomyelitis short stature
|
|
|
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 |
| onset of the sensory block |
onset of the sensory block upto 10 minutes after spinal anesthesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Time to peak sensory block.
Duration of the sensory block
Time to complete motor block.
Duration of the motor block
Intraoperative Hemodynamic.
Complications.(If any )
|
Duration of sensory block |
|
|
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)
|
30/12/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
30/12/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
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
|
The aim of this study to compare the clinical efficacy of equal volume(2ml) of .75% hyperbaric ropivacaine and 0.5% hyperbaric levobupivacaine for cesarean section under spinal anaesthesia |