| CTRI Number |
CTRI/2023/10/059159 [Registered on: 26/10/2023] Trial Registered Prospectively |
| Last Modified On: |
10/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing two different local anaesthetic agents for spinal anaesthesia in view of hemodynamic changes |
|
Scientific Title of Study
|
A Comparative study of 0.5% hyperbaric Levobupivacaine and 0.5% hyperbaric Bupivacaine for spinal anaesthesia in elective lower segment casearean sections |
| 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 SINGIDI PRASANTHI |
| Designation |
Post graduate student |
| Affiliation |
Shimoga institute of medical sciences |
| Address |
Department of Anesthesiology,Major OT complex,3rd floor,Mcgann District Teaching Hospital, Shimoga
Shimoga
KARNATAKA
577201
India |
| Phone |
7680916239 |
| Fax |
|
| Email |
prassusindhu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashwini S |
| Designation |
Associate professor |
| Affiliation |
Shimoga institute of medical sciences |
| Address |
Department of Anesthesiology, Major OT complex,3rd floor, Mcgann District Teaching Hospital, Shimoga
Shimoga
KARNATAKA
577201
India |
| Phone |
9980812398 |
| Fax |
|
| Email |
ashwini.satrasala@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashwini S |
| Designation |
Associate professor |
| Affiliation |
Shimoga institute of medical sciences |
| Address |
Department of Anesthesiology, Major OT complex,3rd floor, Mcgann District Teaching Hospital, Shimoga
Shimoga
KARNATAKA
577201
India |
| Phone |
9980812398 |
| Fax |
|
| Email |
ashwini.satrasala@gmail.com |
|
|
Source of Monetary or Material Support
|
| MCGANN TEACHING DISTRICT HOSPITAL,SIMS SHIMOGA |
|
|
Primary Sponsor
|
| Name |
Dr SINGIDI PRASANTHI |
| Address |
Department of Anesthesiology Major OT complex 3rd floor
Mcgann District Teaching Hospital |
| Type of Sponsor |
Other [Self] |
|
|
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 Ashwini |
MC gann teaching district hospital |
3rd floor Mcgann District Teaching Hospital Shimoga institute of medical sciences Department of Anesthesiology
Shimoga
KARNATAKA |
9980812398
ashwini.satrasala@gmail.co |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee (IEC)SIMS |
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 |
Comparator agent 0.5% hyperbaric Bupivacaine
|
Group 1 will receive 0.5% hyperbaric Levobupivacaine 2ml intrathecally
Group 2 will receive 0.5% hyperbaric Bupivacaine 2ml
intrathecally
Duration 18months |
| Intervention |
Intervention agent 0.5% hyperbaric Levobupivacaine |
Group 1 will receive 0.5% hyperbaric Levobupivacaine 2ml intrathecally
Duration 18months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1.Patients undergoing elective lower segment casearean sections from 18-40years age
2.ASA physical status II |
|
| ExclusionCriteria |
| Details |
1.Patients with ASA physical status III,IV
2.Patients having any contraindications to spinal anaesthesia
3.Patients with history of allergy to local anaesthetic |
|
|
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 |
To compare various effects of intrathecal 0.5% Hyperbaric Levobupivacaine & 0.5%hyperbaric Bupivacaine in elective lower segment casearean sections
1.Hemodynamic changes |
At Oth minute immediately & then 3 6 9 15 20 25 30 45 60 75 90 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Sensory & motor blockade characteristics |
At 5minutes |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "120"
Final Enrollment numbers achieved (India)="120" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
06/11/2023 |
| Date of Study Completion (India) |
05/05/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="18" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Spinal anaesthesia is the most common anesthesia used in elective and emergency lower segment casearean sections.Hyperbaric solutions are generally preferred in subarachnoid block because they provide sufficient block and do not cause high block levels commonly Bupivacaine has R and S enantiomers they have different affinity on sodium and potassium channels.S enantiomers are relatively less cardiotoxic and neurotoxic.In recent studies Levobupivacaine as safer alternative for regional anesthesia than racemic Bupivacaine. Hence we aim to study hyperbaric Levobupivacaine 0.5%, and Hyperbaric Bupivacaine 0.5%, with respect to hemodynamic changes,block characteristics, postoperative complications |