| CTRI Number |
CTRI/2023/03/050728 [Registered on: 15/03/2023] Trial Registered Prospectively |
| Last Modified On: |
14/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
COMPARISON OF SPINAL ANAESTHESIA WITH HYPERBARIC LEVOBUPIVACAINE AND HYPERBARIC BUPIVACAINE WITH FENTANYL AS ADDITIVE DRUG IN ELECTIVE CESAREAN SECTIONS |
|
Scientific Title of Study
|
COMPARISON OF SPINAL ANAESTHESIA WITH HYPERBARIC LEVOBUPIVACAINE WITH FENTANYL AND HYPERBARIC BUPIVACAINE WITH FENTANYL IN ELECTIVE CESAREAN SECTIONS |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SINCHANA A S |
| Designation |
JUNIOR RESIDENT IN ANAESTHESIOLOGY |
| Affiliation |
Shri B M Patil medical college,VIJAYAPURA |
| Address |
Department of Anaesthesiology,Shri B M Patil medical college,bangaramma sajjana campus,vijayapura
karnataka Pin 586103
Shri B M Patil medical college,bangaramma sajjana campus,vijayapura
karnataka Pin 586103
Bijapur
KARNATAKA
586103
India |
| Phone |
8277240639 |
| Fax |
|
| Email |
sinchusambhrama@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vijay kumar T K |
| Designation |
PROFESSOR |
| Affiliation |
Shri B M Ptil medical college |
| Address |
Department of Anaesthesiology,Shri B M Patil medical college,bangaramma sajjana campus,vijayapura
karnataka Pin 586103
Shri B M Patil medical college,bangaramma sajjana campus,vijayapura
karnataka Pin 586103
Bijapur
KARNATAKA
586103
India |
| Phone |
9844095250 |
| Fax |
|
| Email |
drvijay8@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SINCHANA A S |
| Designation |
JUNIOR RESIDENT IN ANAESTHESIOLOGY |
| Affiliation |
Shri B M Patil medical college |
| Address |
Department of Anaesthesiology,Shri B M Patil medical college,bangaramma sajjana campus,vijayapura
karnataka Pin 586103
Shri B M Patil medical college,bangaramma sajjana campus,vijayapura
karnataka Pin 586103
Bijapur
KARNATAKA
586103
India |
| Phone |
8277240639 |
| Fax |
|
| Email |
sinchusambhrama@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri B M Patil Medical college hospital,Bangaramma sajjana campus,BLDE University,vijayapura,karnataka,pin 586103 centre,vijayapura,karnataka |
|
|
Primary Sponsor
|
| Name |
Shri B M Patil medicaal college hospital and Reaseach centre |
| Address |
Shri B M Patil Medical college hospital and Reseach centre,vijayapura,karnataka |
| 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 |
| SINCHANA A S |
Shri B M Patil Medical college |
Deapartment of anaesthesiology,BLDE University,Bangaramma sajjan campus,vijayapura,karnataka 586103
Bijapur
KARNATAKA |
8277240639
sinchusambhrama@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical committe |
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 |
| Comparator Agent |
Bupivacaine |
A local anesthetic drug used in spianl anaesthesia
Route:Intrathecal
dose:10mg bupivacaine with 25mcg fentanyl |
| Intervention |
Levobupivacaine |
A local anaesthetic agent used in spinal anasethesia.It is a enantiomer of bupivacaine.
Route:Intrathecal
dose :10mg levobupivacaine with 25mcg fentanyl |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Women more than 37 weeks period of gestation
ASA GRADE 1 AND 2
Scheduled for elective cesarean sections |
|
| ExclusionCriteria |
| Details |
Having contraindications to regional anesthesia
Body weight more than 100kg
Shorter than 150cm
Taller than 175cm
Having systemic diseases
Expected mothers with foetal anomaly,placenta previa,abruptio placenta. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the and compare the sensory,motor block characteristics and hemodynamic changes with hyperbaric bupivacaine and levobupivacaine in 24 hrs after administartion of the drug.
To assess the prolongation of block when fentanyl is used. |
24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the side effects like cardiotoxicity and neurotoxicity associated with levobupivacaine and bupivacaine. |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="130"
Sample Size from India="130"
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)
|
20/03/2023 |
| 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="2"
Months="2"
Days="12" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Two groups were divided randomly and one group was given levobupivacine with fentanyl 25mcg intrathecally,and other group received bupivacine with fentanyl 25mcg intrathecally.Twp groups were compared with onset of sensory blocl,onset of motor block,onset of analgesia,time to reach maximum level,total duration of analgesia,time of regression of dermatome. Secondary objective was to find out about adverse effects associaated with two drugs like hypotension,bradycardia,shivering,nausea,vomiting,itching and cardiotoxicity,neurotoxicity.Results of the two groups were monitored every 2 minutes in first half an hour,every 15 min for next 2 hours and hourly upto 24 hours. |