| CTRI Number |
CTRI/2023/01/048768 [Registered on: 05/01/2023] Trial Registered Prospectively |
| Last Modified On: |
20/12/2022 |
| 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
|
A Randomized prospective study comparing efficacy of 0.5% Hyperbaric Levobupivacaine with 0.5% Hyperbaric Bupivacaine for subarachnoid block in Orthopedic lower limb surgeries
|
|
Scientific Title of Study
|
A Randomized prospective study comparing efficacy of 0.5% Hyperbaric Levobupivacaine with 0.5% Hyperbaric Bupivacaine for subarachnoid block in Orthopedic lower limb surgeries
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| TMH/IEC/JUNE/036/2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
NIHARIKA SINGH |
| Designation |
DNB TRAINEE, DEPARTMENT OF ANAESTHESIOLOGY |
| Affiliation |
TATA MAIN HOSPITAL |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, MEDICAL SERVICES DIVISION , MAIN OPERATION THEATRE, 2ND FLOOR
PURBI SINGHBHUM
831001
INDIA
DEPARTMENT OF ANAESTHESIOLOGY, MEDICAL SERVICES DIVISION , MAIN OPERATION THEATRE, 2ND FLOOR
PURBI SINGHBHUM
831001
INDIA
Purbi Singhbhum
JHARKHAND
831001
India |
| Phone |
8218430637 |
| Fax |
|
| Email |
niharikasinghsuman@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr SHARAD KUMAR |
| Designation |
CONSULTANT , |
| Affiliation |
TATA MAIN HOSPITAL,JAMSHEDPUR |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, MEDICAL SERVICES DIVISION , MAIN OPERATION THEATRE, 2ND FLOOR
PURBI SINGHBHUM
831001
INDIA
DEPARTMENT OF ANAESTHESIOLOGY, MEDICAL SERVICES DIVISION , MAIN OPERATION THEATRE, 2ND FLOOR
PURBI SINGHBHUM
831001
INDIA
Purbi Singhbhum
JHARKHAND
831001
India |
| Phone |
7763807750 |
| Fax |
|
| Email |
drskumar@tatasteel.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr SHARAD KUMAR |
| Designation |
CONSULTANT , |
| Affiliation |
TATA MAIN HOSPITAL,JAMSHEDPUR |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, MEDICAL SERVICES DIVISION , MAIN OPERATION THEATRE, 2ND FLOOR
PURBI SINGHBHUM
831001
INDIA
DEPARTMENT OF ANAESTHESIOLOGY, MEDICAL SERVICES DIVISION , MAIN OPERATION THEATRE, 2ND FLOOR
PURBI SINGHBHUM
831001
INDIA
Sahibganj
JHARKHAND
831001
India |
| Phone |
7763807750 |
| Fax |
|
| Email |
drskumar@tatasteel.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
TATA MAIN HOSPITAL |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY MEDICAL SERVICES DIVISION , MAIN OPERATION THEATRE , 2nd FLOOR JAMSHEDPUR JHARKHAND 831001 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| TATA MAIN HOSPITAL |
DEPARTMENT OF ANAESTHESIOLOGY MEDICAL SERVICES DIVISION , MAIN OPERATION THEATRE , 2nd
JAMSHEDPUR JHARKHAND FLOOR ,831001 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| NIHARIKA SINGH |
TATA MAIN HOSPITAL |
DEPARTMENT OF ANAESTHESIOLOGY, MEDICAL SERVICES DIVISION , MAIN OPERATION THEATRE, 2ND FLOOR
PURBI SINGHBHUM
831001
INDIA
Purbi Singhbhum
JHARKHAND |
8218430637
niharikasinghsuman@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| TATA MAIN HOSPITAL INSTITUIONAL ETHICS COMMITTEE,, JAMSHEDPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: W183||Other and unspecified fall on samelevel, (2) ICD-10 Condition: W010||Fall on same level from slipping,tripping and stumbling without subsequent striking against object, (3) ICD-10 Condition: S729||Unspecified fracture of femur, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
0.5% BUPIVACAINE HEAVY |
3ml OF 0.5% BUPIVACAINE IN SUBARACHNOID BLOCK |
| Intervention |
LEVOBUPIVACAINE HEAVY |
3ml of 0.5% LEVOBUPIVACAINE HEAVY IN SUBARACHNOID BLOCK |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Adult (Age ≥ 18 - 60 Years) undergoing orthopedic lower limb surgeries under Subarachnoid block
2 . ASA grade I and II
3.Anticipated Duration of surgery 120 minutes
|
|
| ExclusionCriteria |
| Details |
1. Patient refusal to participate in study
2. Contraindication to subarachnoid block
3. Patients with height < 150 cm or > 180 cm
4. Patients with BMI ≥ 30
5. Patient with history of allergy to local anaesthetics
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the onset and duration of sensory block with 0.5% Hyperbaric Levobupivacaine and 0.5% Hyperbaric Bupivacaine after subarachnoid block in adult patients undergoing Orthopedic lower limb surgeries .
|
SEPTEMBER 2022 TO JUNE2024 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To determine the following parameters in patients receiving 0.5% Hyperbaric Levobupivacaine and 0.5% Hyperbaric Bupivacaine:
1. Onset and duration of motor block
2. Hemodynamic stability
3. Total dose of vasopressor required
4. Incidences of intraoperative complications: Hypotension, Bradycardia, Nausea and Vomiting
|
SEPTEMBER2022 TO JUNE 2024 |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
30/01/2023 |
| 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="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Study
to establish onset and duration of sensory block , motor
block and
hemodynamic stability after subarachnoid
block in adult patients undergoing Orthopedic
lower limb surgeries using 3ml of 0.5% Hyperbaric Levobupivacaine
and 3ml 0.5%
Hyperbaric Bupivacaine. |