| CTRI Number |
CTRI/2024/06/069543 [Registered on: 26/06/2024] Trial Registered Prospectively |
| Last Modified On: |
25/06/2024 |
| 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 evaluate and compare the efficacy and adverse effects of combination levobupivacaine heavy with morphine versus bupivacaine heavy with morphine in lscs under Spinal anaesthesia |
|
Scientific Title of Study
|
Comparative evaluation of intrathecal anaesthetic efficacy of combination of hyperbaric levobupivacaine with morphine versus hyperbaric bupivacaine with morphine in caesarean section- a double blinded randomized clinical trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MAHIN PRABHU |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
JSS ACADEMY OF HIGHER EDUCATION AND RESEARCH |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY
JSS HOSPITAL,MYSURU
Mysore
KARNATAKA
570004
India
Mysore KARNATAKA 570004 India |
| Phone |
9094838876 |
| Fax |
|
| Email |
mahinprabhu96@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DR ANIL KUMAR M R |
| Designation |
PROFESSOR |
| Affiliation |
JSS ACADEMY OF HIGHER EDUCATION AND RESEARCH |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY
JSS HOSPITAL,MYSURU
Mysore
KARNATAKA
570004
India
Mysore KARNATAKA 570004 India |
| Phone |
9945155844 |
| Fax |
|
| Email |
dranilkumarmr@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
DR ANIL KUMAR M R |
| Designation |
PROFESSOR |
| Affiliation |
JSS ACADEMY OF HIGHER EDUCATION AND RESEARCH |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY
JSS HOSPITAL,MYSURU
Mysore
KARNATAKA
570004
Mysore KARNATAKA 570004 India |
| Phone |
9945155844 |
| Fax |
|
| Email |
dranilkumarmr@gmail.com |
|
|
Source of Monetary or Material Support
|
| JSS MEDICAL COLLEGE AND HOSPITAL
Mahatma Gandhi Road, Fort Mohalla, Mysuru, Karnataka 570004 |
|
|
Primary Sponsor
|
| Name |
JSS ACADEMY OF HIGHER EDUCATION AND RESEARCH |
| Address |
JSS MEDICAL COLLEGE AND HOSPITAL,MYSURU |
| Type of Sponsor |
Private 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 MAHIN PRABHU S |
JSS MEDICAL COLLEGE AND HOSPITAL |
Pregnant females posted for elective caesarean section in 2nd floor OT complex, JSS hospital,MG ROAD , Agrahara,MYSURU,Karnataka
570004 Mysore KARNATAKA |
9094838876
mahinprabhu96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JSS Academy Of Higher Education And Research |
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
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | COMBINATION OF HYPERBARIC LEVOBUPIVACAINE WITH MORPHINE | 1.After spinal anesthesia inj. hyperbaric levobupivacaine 2ml with inj. morphine 100mcg given intrathecally and intraoperative quality of anesthesia, hemodynamic parameters are monitored and compared. | | 2 | Comparator Arm (Non Ayurveda) | | - | COMBINATION OF HYPERBARIC BUPIVACAINE WITH MORPHINE | 1.After spinal anesthesia inj. hyperbaric bupivacaine 2ml with inj. morphine 100mcg given intrathecally and intraoperative quality of anesthesia, hemodynamic parameters are monitored and compared. |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Parturients of ASA II aged 20 to 40 years with gestational age between 37-42 weeks planned foe elective caesaren section |
|
| ExclusionCriteria |
| Details |
Patient refusal
Multiple pregnancy
BMI>30
Patienta with known history of PIH and GDM
Any contraindications to spinal anaesthesia |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess and compare the time taken by the drugs to achieve maximum sensory level and motor blockade |
From the commencement of sensory and motor blockade till post operative regression of motor and sensory. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
a) To assess the hemodynamic parameters.
b) To evaluate postoperative pain.
c)To monitor for any side effects.
|
From the commencement of spinal anaesthesia till post operative recovery period |
|
|
Target Sample Size
|
Total Sample Size="90" Sample Size from India="90"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
06/07/2024 |
| 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="6" 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
|
90
parturients, belonging American Society of Anaesthesiologists Physical status
(ASA-PS) class II planned for elective lower segment caesarean section (LSCS)
under spinal anaesthesia (SA), will be thoroughly evaluated as a part of
preanaesthetic evaluation, 24hours prior to the procedure. Fasting of 6 hours
for solids and 2 hours for clear liquids will be ensured. Intravenous (IV)
access will be secured in the ward as per our institutional policy. All
patients will be randomised into two groups using shuffled sealed opaque
envelop (SNOSE) technique.
Group
B- Will receive 10mg (2ml) of 0.5%
hyperbaric bupivacaine-(H) and 100mcg morphine.
Group
L- Will receive 10mg(2ml) of 0.50 %
hyperbaric levobupivacaine (H) and 100mcg morphine.
To
ensure blinding, the anaesthesiologist who performs spinal anaesthesia will not
be further involved in the study. A different anaesthesiologist designated as
the observer will only enter the operation theatre after spinal anaesthesia has
been administered. Neither the observer nor the parturient will be disclosed
any information regarding which drug to be administered. Hence the observer and
the parturient will be blinded for the study.
In
the operation theatre standard monitoring devices will be attached, including
electrocardiography (ECG), automated NIBP (non-invasive blood pressure), pulse
oximetry (SpO2) and baseline values of SBP (systolic blood
pressure), DBP (diastolic blood pressure), MAP (mean arterial pressure) will be
recorded. The hemodynamic multiparameter monitor will be placed in the direct
line of vision of the anaesthesiologist performing the Spinal Anaesthesia.
Spinal anaesthesia will be administered using 25 G Quincke’s needle at the
L2–L3 or L3–L4 interspace in sitting position. Immediately after administration
of spinal anaesthesia, the parturient will be made to lie down in supine
posture with 10 cm wedge beneath the right buttock.
Intraoperatively
sensory blockade will be checked using pin prick method and motor blockade will
be checked by modified Bromage score. The level of sensory and motor block will
be assessed every 1 minute for the 1st 10 minutes and every 5
minutes till the completion of the surgery. Surgery will be allowed to start
once the sensory level reaches T6 level.
Any
hypotension, defined as a decrease in systolic blood pressure of < 20% below
baseline, will be managed using 6 mg of intravenous ephedrine.
Heart
rate will be monitored every minute for the first 10 mins and every 5 mins for
the next 30mins Any bradycardia with heart rate < 60bpm will be managed by
using 0.6mg of intravenous atropine.
Perioperatively
subjects will be followed up till they regain their motor power and sensation. In
the immediate postoperative period, all patients will receive intravenous Inj.
Paracetamol 1g 6th hourly. Postoperative analgesia will be assessed using
VAS score and a rescue analgesic of Inj. Diclofenac will be given if the VAS
score is found to be greater than or equal to 3. |