| CTRI Number |
CTRI/2023/06/054293 [Registered on: 22/06/2023] Trial Registered Prospectively |
| Last Modified On: |
21/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Study to compare Levobupivacaine heavy & Bupivacaine heavy in spinal anesthesia for below belly button operations. |
|
Scientific Title of Study
|
To compare the efficacy of hyperbaric Levobupivacaine(0.5%) versus hyperbaric Bupivacaine (0.5%) in subarachnoid block for infra umbilical surgeries. |
| 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 Rachna Gupta |
| Designation |
PG Resident |
| Affiliation |
Gajra raja Medical college |
| Address |
department of anaesthesiology, 7th floor ,1000 bedded hospital,gwalior
Gwalior
MADHYA PRADESH
474009
India |
| Phone |
8462024311 |
| Fax |
|
| Email |
ruchiguptaa2503@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jitendra Agrawal |
| Designation |
Professor |
| Affiliation |
Gajra raja Medical college |
| Address |
Department of Anaesthesiology, 7th floor , 1000 bedded hospital,gwalior
Gwalior
MADHYA PRADESH
474009
India |
| Phone |
9300009942 |
| Fax |
|
| Email |
drjagrawal9@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jitendra Agrawal |
| Designation |
Professor |
| Affiliation |
Gajra raja Medical college |
| Address |
Department of Anaesthesiology, 7th floor , 1000 bedded hospital ,Gwalior
MADHYA PRADESH
474009
India |
| Phone |
9300009942 |
| Fax |
|
| Email |
drjagrawal9@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, GRMC,Gwalior, Madhya Pradesh, 474009 |
|
|
Primary Sponsor
|
| Name |
Dr Rachna Gupta |
| Address |
senior girls hostel , jayarogya group of hospital . pincode 474009 |
| Type of Sponsor |
Government 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 Rachna Gupta |
jayarogya group of hospitals |
Department of Anaesthesiology, 1000 bedded hospital ,Gwalior, Madhya Pradesh, 474009
Gwalior
MADHYA PRADESH |
8462024311
ruchiguptaa2503@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Gajra raja Medical College, Gwalior |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N433||Hydrocele, unspecified, (2) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene, (3) ICD-10 Condition: S829||Unspecified fracture of lower leg, (4) ICD-10 Condition: N814||Uterovaginal prolapse, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bupivacaine heavy |
3 ml of Bupivacaine 0.5% in subarachnoid block for infra umbilical surgeries |
| Comparator Agent |
Levobupivacaine heavy |
3 ml of Levobupivacaine 0.5% in subarachnoid block for infra umbilical surgeries |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Age between 20-65 years
ASA grade I and II
Patient scheduled for infra umbilical surgeries |
|
| ExclusionCriteria |
| Details |
Patients not giving consent to participate in the study.
Uncooperative patient
Patients with respiratory, cardiovascular, renal diseases, obesity.
Neurological disease (multiple sclerosis, symptomatic lumbar herniated disc,
spinal stenosis)
Abnormal coagulopathy
Patient with known hypersensitivity to local anaesthetic.
Local sepsis or infection |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Its expected that time of onset of motor block is shorter & lasted longer with bupivacaine 0.5% when compared with levobupivacaine0.5% .
Time to achieve highest sensory block is faster in levobupivacaine0.5% compared to bupivacaine 0.5% . |
12 HOURS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Its expected that levobupivacaine heavy is haemodynamically more stable than bupivacaine heavy. |
12 hours |
|
|
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)
|
30/06/2023 |
| 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 Yet Recruiting |
| 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
|
This study is a prospective randomized controlled study to compare the efficacy of 3ml of levobupivacaine 0.5% when compared with 3 ml of bupivacaine 0.5% in subarachnoid block for infra umbilical surgeries . It is expected that levobupivacaine is haemodynamically more stable as compared to bupivacaine. |