| CTRI Number |
CTRI/2023/10/058526 [Registered on: 11/10/2023] Trial Registered Prospectively |
| Last Modified On: |
07/10/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
PROSPECTIVE OBSERVATIONAL STUDY |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to view the effects of a drug Levobupivacaine, used to provide muscle paralysis and insensitivity to pain in surgeries . |
|
Scientific Title of Study
|
" A study of clinical effects of 0.5% hyperbaric levobupivacaine for spinal Anaesthesia." |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR VISHNU VC |
| Designation |
POST GRADUATE |
| Affiliation |
Dr BR Ambedkar Medical College, Bengaluru |
| Address |
Ot complex, 1st floor, department of anaesthesia,Dr BR Ambedkar Medical College, Bengaluru, Karnataka
Bangalore
KARNATAKA
560045
India |
| Phone |
7592068345 |
| Fax |
|
| Email |
vcvishnu007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR M SALIM IQBAL |
| Designation |
PROFESSOR |
| Affiliation |
Dr BR Ambedkar Medical College, Bengaluru |
| Address |
Ot complex, 1st floor, department of anaesthesia,Dr BR Ambedkar Medical College, Bengaluru, Karnataka
Bangalore
KARNATAKA
560045
India |
| Phone |
9964651079 |
| Fax |
|
| Email |
drsalim_iqbal@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
DR VISHNU VC |
| Designation |
POST GRADUATE |
| Affiliation |
Dr BR Ambedkar Medical College, Bengaluru |
| Address |
Ot complex 1st floor, department of anaesthesia,Dr BR Ambedkar Medical College, Bengaluru, Karnataka
Bangalore
KARNATAKA
560045
India |
| Phone |
7592068345 |
| Fax |
|
| Email |
vcvishnu007@gmail.com |
|
|
Source of Monetary or Material Support
|
| DR B.R.AMBEDKAR MEDICAL COLLEGE AND HOSPITAL,ot complex K.G.HALLI, BANGALORE -45 |
|
|
Primary Sponsor
|
| Name |
Dr B R Ambedkar medical College and hospital |
| Address |
Dr. B. R. Ambedkar medical College and hospital, Bangalore |
| 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 VISHNU VC |
OT complex, DR. B.R. AMBEDKAR MEDICAL COLLEGE AND HOSPITAL |
Ot complex, 1st floor, department of anaesthesia,DR. B.R. AMBEDKAR MEDICAL COLLEGE AND HOSPITAL,
KADUGONDANAHALLI, BENGALURU – 560045.
Bangalore
KARNATAKA |
7592068345
vcvishnu007@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTION ETHICS COMMITTEE DR BR AMBEDKAR MEDICAL COLLEGE,BANGALORE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
hyperbaric levobupivacaine 0.5% |
hyperbaric levobupivacaine 0.5% is a drug injecting intrathecally in spinal anaesthesia procedure |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
A)All patients aged between 18 to 60 years of age posted for elective surgeries under spinal anaesthesia.
b) ASA grade I and II patient
|
|
| ExclusionCriteria |
| Details |
patients with bleeding and coagulation disorders
and local site infections are excluded. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the total duration of analgesia with intrathecal 0.5% hyperbaric levobupivacaine. |
every two hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Sensory Block
a) Maximum height of block achieved
b) Time to maximum sensory block
2) Motor block
a) Time of Maximum Motor Block
b) Time to complete motor recovery.
3) To assess side effects if any
1) Hypotension
2) Bradycardia
3) Nausea
4) Vomiting
|
24 hrs |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
20/10/2023 |
| 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="1"
Months="6"
Days="0" |
|
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
|
HYPERBARIC LEVOBUPIVACAINE 0.5% IS A SAFER DRUG FOR SPINAL ANAESTHESIA , THIS STUDY IS TO OBSERVE THE CLINICAL EFFECTS OF HYPERBARIC LEVOBUPIVACAINE |