| CTRI Number |
CTRI/2024/02/062467 [Registered on: 08/02/2024] Trial Registered Prospectively |
| Last Modified On: |
01/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study To Compare The Sensory And Muscle Paralysis Characteristics Of A Drug Named Levobupivacaine 0.5% Heavy And
0.5% Bupivacaine Heavy For Spinal Anaesthesia for surgery in pregnant patients named caesarean section |
|
Scientific Title of Study
|
A Comparative Study Of Hyperbaric Levobupivacaine 0.5% With Hyperbaric Bupivacaine 0.5% For Spinal Anaesthesia In Elective Lower Segment Cesarean Section Cases |
| 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 Madhu S N |
| Designation |
Postgraduate Medical Student |
| Affiliation |
Bangalore Medical College and Research Institute |
| Address |
Department on Anaesthesia room no 3, 3rd floor tippu sultan, Fort,
Krishna Rajendra Rd, Bangalore, Karnataka
Bangalore
KARNATAKA
560002
India |
| Phone |
8095411038 |
| Fax |
|
| Email |
sn.madhu97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinay Marulasiddappa |
| Designation |
Professor |
| Affiliation |
Bangalore Medical College and Research Institute |
| Address |
Department on Anaesthesia room no 666, 3rd floor tippu sultan, Fort,
Krishna Rajendra Rd, Bangalore, Karnataka
Bangalore
Bangalore
KARNATAKA
560002
India |
| Phone |
8073997005 |
| Fax |
|
| Email |
drvinaym@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vinay Marulasiddappa |
| Designation |
Professor |
| Affiliation |
Bangalore Medical College and Research Institute |
| Address |
Department on Anaesthesia room no 666, 3rd floor tippu sultan, Fort,
Krishna Rajendra Rd, Bangalore, Karnataka
Bangalore
Bangalore
KARNATAKA
560002
India |
| Phone |
8073997005 |
| Fax |
|
| Email |
drvinaym@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, Bangalore Medical College and Research Institute |
|
|
Primary Sponsor
|
| Name |
Dr Madhu S N |
| Address |
Fort, Krishna Rajendra Rd, Bengaluru, Karnataka |
| 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 madhu s n |
Bangalore Medical College |
Department on
Anaesthesia, Main ot
complex room no 1-6,
3rd floor tippu sultan,
Fort, Krishna Rajendra
Rd, Bangalore,
Karnataka
KARNATAKA
Bangalore
KARNATAKA
Bangalore
KARNATAKA |
8095411038
sn.madhu97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Bangalore Medical College and Research Institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
0.5% hyperbaric Bupivacaine |
Patient will be positioned in left lateral position and under strict aseptic conditions, lumbar puncture done using midline approach at L2-L3 intervertebral space with a 25G Quincke-Babcock spinal needle 2ml of drug will be delivered in subarachnoid space at rate of 0.2ml/sec. |
| Intervention |
0.5% Hyperbaric Levobupivacaine |
Patient will be positioned in left lateral position and under strict aseptic conditions, lumbar puncture done using midline approach at L2-L3 intervertebral space with a 25G Quincke-Babcock spinal needle, 2ml of drug will be delivered in subarachnoid space at rate of 0.2ml/sec for 10 seconds |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1.Parturients posted for Elective Cesarean section and who give written informed consent for spinal anaesthesia.
2.Parturients aged between 18 years and 40 years
|
|
| ExclusionCriteria |
| Details |
1.Patients refusal to participate in the study.
2.Contraindications to spinal anaesthesia(sepsis, local infections, spinal deformity,coagulopathies).
3.Period of gestation less than 35 weeks and more than 40 weeks.
4.Height less than155cm and more than 175cm.
5.BMI less than 18.5 kg/m2and more than 30 kg/m2.
6.Parturients with gestational hypertension, cardiovascular disorders and other coexisting systemic disorders.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the effect of hyperbaric levobupivacaine 0.5% with hyperbaric bupivacaine 0.5% on :
Sensory and motor characteristics in subarachnoid block
|
and at every 1minute interval for first 3 consecutive minutes followed by 5 minute intervals for the next 15minutes and at 15 minute intervals till the end of the surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the effects of the 2 drugs on heart
rate, systolic blood pressure, diastolic blood
pressure, mean arterial pressure, saturation of
oxygen & the incidence of adverse effects if any
|
and at every 1minute interval for first 3 consecutive minutes followed by 5 minute intervals for the next 15minutes and at 15 minute intervals till the end of the surgery. |
|
|
Target Sample Size
|
Total Sample Size="112"
Sample Size from India="112"
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)
|
12/02/2024 |
| 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="0"
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
|
Studies have been done to compare the charecteristics of both drugs .The results showed that the onset of sensory block and complete motor block was shorter in patients receiving levobupivacaine than bupivacaine.Hemodynamic stability was more with levobupivacaine. The aim of this study is to compare the anaesthetic effect and hemodynamic effects of hyperbaric levobupivacaine 0.5% with hyperbaric bupivacaine 0.5% when given in subarachnoid block in patients undergoing lower segment cesarean section. |