| CTRI Number |
CTRI/2024/02/063088 [Registered on: 23/02/2024] Trial Registered Prospectively |
| Last Modified On: |
22/02/2024 |
| 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
|
comparative study to see which drug, hyperbaric levobupivacaine or Hyperbaric Ropivacaine, to give better anesthesia. |
|
Scientific Title of Study
|
Comparative study of efficacy ,motor,sensory blockade and duration of blockade of intrathecal hyperbaric levobupivacaine with fentanyl and hyperbaric ropivacaine with fentanyl in lower abdominal and lower extremity surgery |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mangesh Gore |
| Designation |
Associate Professor |
| Affiliation |
Topiwala National Medical College and B,Y.L.Nair charitable hospital, Mumbai |
| Address |
302,Depatment of Anesthesiology,T.N.M.C and B.Y.L.Nair Charitable Hospital,Mumbai-400008
302,Department of Anesthesiology,T.N.M.C and B.Y.L.Nair charitable Hospital,Mumbai-08
Mumbai
MAHARASHTRA
400081
India |
| Phone |
9223233165 |
| Fax |
|
| Email |
drmangeshg166@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mangesh Gore |
| Designation |
Associate Professor |
| Affiliation |
Topiwala National Medical College and B,Y.L.Nair charitable hospital, Mumbai |
| Address |
1103, Shreeram Apartments, Opposite Akruti Elegance,90 Feet Road, Gavanpada Mulund East
302,Department of Anesthesiology,T.N.M.C and B.Y.L.Nair charitable hospital,Mumbai-08
Mumbai
MAHARASHTRA
400081
India |
| Phone |
9223233165 |
| Fax |
|
| Email |
drmangeshg166@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
K.Deepa |
| Designation |
P.G.Student |
| Affiliation |
Topiwala National Medical College and B,Y.L.Nair charitable hospital, Mumbai |
| Address |
302,Department of Anesthesiology,T.N.M.C and B.Y.L.Nair charitable Hospital.Mumbai-400008
Mumbai
MAHARASHTRA
400008
India |
| Phone |
7022221910 |
| Fax |
|
| Email |
deepa1607k@gmail.com |
|
|
Source of Monetary or Material Support
|
| Topiwala National Medical College and B.Y.L.Nair Charitable Hospital,Mumbai-400008 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 |
| DrMangesh Suresh Gore |
Topiwala National Medical College,Mumbai |
302,Department of Anesthesiology,College Building
Mumbai
MAHARASHTRA |
02223027137
entropy.tnmc@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Commitee for Academic Reasearch Projects |
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 |
injection Ropivacaine 0.5% ( heavy/Hyperbaric) with injection fentanyl 50 microgram. |
Subarachnoid block is performed with Hyperbaric Injection Ropivacaine 0.5% .Density of sensory block.motor block and duration of block are measured as primary objectives.Hemodynamic changes if any are measured as secondary objectives.the Block is performed only once.The study will last till sensory block receds two segments lower than maximum level achieved. |
| Comparator Agent |
Subarachnoid block with Hyperbaric levobupivacaine 0.5% (heavy) and fentanyl 50 microgram |
hyperbaric (0.5%) Levobupivacaine with fentanyl used for subarachnoid block.The level of sensory blockade,density of motor blockade,duration of blockade are measured as primary objectives.Hemodynamic variations if any are compared as secondary objectives. The block is performed only once.The study will last till sensory block receds two segments lower than maximum level achieved. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) patients for lower abdominal surgeries
2) patients for lower limb surgeries |
|
| ExclusionCriteria |
| Details |
1) pregnancy
2) allergy to local anesthetics |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
To determine the characteristics of subarachnoid block induced by hyperbaric Inj. Levobupivacaine
0.5% with fentanyl and hyperbaric ropivacaine 0.75% with fentanyl in lower abdominal and lower
extremity surgerie |
motor block is assesed at 5 ,10, 15 and 20 minutes and sensory
block at 5, 10 , 15, 20, 30, 45, 60, 90 and 120 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the hemodynamic changes & side effects |
motor block is assesed at 5 ,10, 15 & 20 minutes & sensory
block at 5, 10 , 15, 20, 30, 45, 60, 90 & 120 minutes |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
20/03/2024 |
| 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 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
|
In this study, we will evaluate and compare the influence of hyperbaric Levobupivacaine and
hyperbaric Ropivacaine on onset, duration of motor and sensory blockade, the incidence of side
effects and complications particularly bradycardia, hypotension, fall of mean arterial pressure etc for
spinal anaesthesia in patients undergoing lower abdominal and lower limb Surgeries.
In this study our objective is to compare hyperbaric levobupivacaine to hyperbaric ropivacaine for
providing operative anaesthesia in the population which will help us to collect data in indian
population and know which is better and safer drug and increase its use in the future |