| CTRI Number |
CTRI/2024/08/071977 [Registered on: 06/08/2024] Trial Registered Prospectively |
| Last Modified On: |
31/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of hemodynamic profile of 0.5% hyperbaric Levobupivacaine and 0.5% hyperbaric Bupivacaine for spinal anaesthesia |
|
Scientific Title of Study
|
Comparison of hemodynamic profile of 0.5% hyperbaric Levobupivacaine and 0.5% hyperbaric Bupivacaine in patients undergoing Lower Limb Arthroscopic Surgeries under spinal anaesthesia, a prospective randomized control study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vikram C |
| Designation |
PG Trainee |
| Affiliation |
Institute of Naval Medicine, INHS ASVINI |
| Address |
OT Complex, third floor INHS Asvini, Near RC Church, Colaba, Mumbai
Mumbai
MAHARASHTRA
400005
India |
| Phone |
7411056234 |
| Fax |
|
| Email |
vikram.cherkur@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vidhu Bhatnagar |
| Designation |
Head of the Department, Anaesthesiology and critical care |
| Affiliation |
Institute of Naval Medicine, INHS ASVINI |
| Address |
OT complex, third floor,INHS Asvini, Near RC Church, Colaba, Mumbai
HOD chamber, OT complex, third floor, INHS Asvini, Near RC Church, Colaba, Mumbai
Mumbai
MAHARASHTRA
400005
India |
| Phone |
99697771668 |
| Fax |
|
| Email |
vizardsvids@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vidhu Bhatnagar |
| Designation |
Head of the Department, Anaesthesiology and critical care |
| Affiliation |
Institute of Naval Medicine, INHS ASVINI |
| Address |
HOD chamber, OT complex,third floor, INHS Asvini, Near RC Church, Colaba, Mumbai
HOD chamber, OT complex,third floor,INHS Asvini, Near RC Church, Colaba, Mumbai
Mumbai
MAHARASHTRA
400005
India |
| Phone |
99697771668 |
| Fax |
|
| Email |
vizardsvids@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Naval Medicine, INHS ASVINI, Near RC Church, Colaba, Mumbai, Maharashtra 400005 |
|
|
Primary Sponsor
|
| Name |
Vikram C |
| Address |
INHS ASVINI, Institute of Naval Medicine,Near RC Church, Colaba, Mumbai, Maharashtra 400005 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Vikram C |
INHS ASVINI |
3rd floor, OT, Anaesthesia department, Near RC Church, Colaba, Mumbai, Maharashtra 400005
Mumbai
MAHARASHTRA |
7411056234
vikram.cherkur@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INHS ASVINI ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M999||Biomechanical lesion, unspecified, (2) ICD-10 Condition: M999||Biomechanical lesion, unspecified, (3) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
0.5% hyperbaric
Levobupivacaine |
is a local anesthetic similar to bupivacaine but is the S(-)-enantiomer of bupivacaine. It is the spinal anaesthetic drug expected to have better haemodynamic stability. |
| Comparator Agent |
0.5% hyperbaric Bupivacaine |
It is amino amide class of local anaesthetic. It is the spinal anaesthetic drug with which hemodynamic profile of the interventional agent is being compared. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA Grade 1 and 2
Patients undergoing lower limb arthroscopic surgeries under spinal anaesthesia
|
|
| ExclusionCriteria |
| Details |
Patients who are unwilling
Known hypersensitivity to any of the test drug
Any contraindication to spinal anaesthesia
Cardiac arrythmias/ severe cardiac disease |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the hemodynamic effects between 0.5% Hyperbaric Bupivacaine and 0.5% Hyperbaric Levobupivacaine |
Intraoperative hemodynamic parameters (BP, HR, and MAP)
will be assessed at 1 minute before (baseline) and 1, 2, 3,
and 5 minutes after the induction of spinal anesthesia.
Thereafter, measurements will be performed in 5-minute
intervals during the first 30 minutes of surgery and then
every 10 minutes until the end of the surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Duration of analgesia
2.Sensory and motor block onset
3. Segmental height of block
4. Adverse events |
1.Total duration of analgesia in minutes.
2.The degree of motor block onset in the lower limbs will be assessed at 5 min, 10 min, and 15 min using a modified Bromage scale (MBS). Highest sensory block level attained was checked by using the pinprick method
3.Maximum segmental height block after 15min.
4.Any adverse events noted during entire anaesthesia. |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
15/08/2024 |
| 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
|
Subarachnoid blockade is a principal technique in lower extremity surgical
anesthesia. This study primarily aims to provide a comprehensive analysis of the differences
in hemodynamic stability between 0.5% hyperbaric Levobupivacaine and 0.5% hyperbaric Bupivacaine. Secondarily
study anaesthetic efficacy, onset of sensory and motor blockade, patient recovery and overall
surgical outcomes in elective lower limb surgeries. All these results can help make
Subarachnoid blockade safer and tailor the drug as per requirement. |