| CTRI Number |
CTRI/2024/05/066935 [Registered on: 07/05/2024] Trial Registered Prospectively |
| Last Modified On: |
05/05/2024 |
| 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 Levobupivacaine (0.5%) and Ropivacaine (0.75%) in Lower Limb Surgeries under Spinal Anaesthesia |
|
Scientific Title of Study
|
A Randomised comparative study between hyperbaric Levobupivacaine(0.5%) and hyperbaric Ropivacaine(0.75%) in lower limb surgeries under spinal Anaesthesia. |
| 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 Vaibhav Tiwary |
| Designation |
Professor |
| Affiliation |
Llrm medical college |
| Address |
Room No.14 Department of anaesthesiology,beside IT parking, llrm mdical college, meerut
Meerut
UTTAR PRADESH
250004
India |
| Phone |
7830666616 |
| Fax |
|
| Email |
v.tiwari1234@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vaibhav Tiwary |
| Designation |
Professor |
| Affiliation |
Llrm medical college |
| Address |
Room No.14 Department of anaesthesiology,beside IT parking, llrm medical college, meerut
Meerut
UTTAR PRADESH
250004
India |
| Phone |
7830666616 |
| Fax |
|
| Email |
v.tiwari1234@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neelam Singh |
| Designation |
Junior Resident |
| Affiliation |
Llrm medical college meerut |
| Address |
Room No.14 Department of anaesthesiology, beside IT parking, llrm medical college meerut
Meerut
UTTAR PRADESH
250004
India |
| Phone |
8755603581 |
| Fax |
|
| Email |
neelamsingh4264@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room No.14 Department of Anaesthesiology, Beside IT Parking, LLRM Medical College Meerut, Uttar Pradesh-250004 |
|
|
Primary Sponsor
|
| Name |
LLRM Medical College |
| Address |
Room No.14 Department of Anaesthesiology, Beside IT Parking, LLRM Medical College Meerut Uttar Pradesh 250004 |
| 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 Neelam Singh |
LLRM Medical College Meerut |
Room No.14 Department of Anaesthesiology Beside IT Parking, LLRM Medical College Meerut Uttar Pradesh 250004
Meerut
UTTAR PRADESH |
8755603581
neelamsingh4264@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Not Applicable |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: X58||Exposure to other specified factors, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Hyperbaric Levobupivacaine Hydrochloride(0.5%) |
Group A:Levobupivacaine Hydrochloride (0.5%) Dose:15 mg (3ml) given by Spinal needle in Subarachnoid space evaluated for a minimum duration of 6 hrs. |
| Comparator Agent |
Hyperbaric Ropivacaine Hydrochloride (0.75%) |
Group B: Ropivacaine Hydrochloride (0.75%),Dose:22.5 mg(3ml) given by spinal needle in subarachnoid space evaluated for a minimum duration of 6 hours. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA GRADE I and II
Age between 18 to 65 years
Patients undergoing lower limb Surgeries |
|
| ExclusionCriteria |
| Details |
Patient Refusal
Infection at the Injection Site
Coagulopathy
Increased Intracranial Pressure
Known Allergy or Hypersensitivity to Local Anaesthetic Agents |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome is to study the efficacy of the drug based on Duration of motor blockade , assessed by Modified Bromage scale. |
Baseline vitals will be noted. After Spinal anesthesia, Haemodynamic parameters ( SBP,DBP,MAP,HR), Loss of sensory and motor function will be noted every 1 minute for first 5 minutes, every 2 minutes for next 10 minutes, every 5 minutes for next 25 minutes and then every 30 minutes till regression of block. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To compare and Evaluate Onset of sensory block in both the groups
2.To compare and Evaluate Onset of motor block in both the groups
3.To compare and Evaluate Duration of Motor block in both the groups
4.To compare and Evaluate time of first rescue Analgesia in both the groups
5.To compare hemodynamic changes if any
6.Complications if any in both the groups |
Baseline vitals will be noted. After Spinal anesthesia, Haemodynamic parameters ( SBP,DBP,MAP,HR), Loss of sensory and motor function will be noted every 1 minute for first 5 minutes, every 2 minutes for next 10 minutes, every 5 minutes for next 25 minutes and then every 30 minutes till regression of block. |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
20/05/2024 |
| 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="0"
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
|
This study will be carried out to compare the efficacy of Hyperbaric Levobupivacaine and Hyperbaric Ropivacaine in patients undergoing lower limb Surgeries under Spinal Anaesthesia. |