| CTRI Number |
CTRI/2025/07/090268 [Registered on: 07/07/2025] Trial Registered Prospectively |
| Last Modified On: |
05/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
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Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
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Public Title of Study
|
The BRAVO Study: A Comparative Analysis of Bupivacaine, Ropivacaine, and Levobupivacaine in Spinal Anesthesia for Lower Limb and Abdominal Surgeries |
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Scientific Title of Study
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Comparison of Bupivacaine Heavy 0.5 percent Levobupivacaine Heavy 0.5 percent And Ropivacaine Heavy 0.75 percent in Subarachnoid block (SAB) in lower limb and abdominal surgeries: An Open, Comparative and Randamised Study.
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| Trial Acronym |
BRAVO STUDY |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Harshvardhan Tikle |
| Designation |
Additional Professor |
| Affiliation |
TNMC and B.Y.L. Charitable Hospital Mumbai |
| Address |
Department of Anesthesia, TNMC and B.Y.L Charitable Hospital, Mumbai 400008
Mumbai
MAHARASHTRA
400008
India |
| Phone |
9892404649 |
| Fax |
|
| Email |
tiklehrshwardhan@gmail.com |
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Details of Contact Person
Scientific Query
|
| Name |
Dr Harshvardhan Tikle |
| Designation |
Additional Professor |
| Affiliation |
TNMC and B.Y.L. Charitable Hospital Mumbai |
| Address |
Department of Anesthesia, TNMC and B.Y.L Charitable Hospital, Mumbai 400008
Mumbai
MAHARASHTRA
400008
India |
| Phone |
9892404649 |
| Fax |
|
| Email |
tiklehrshwardhan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Harshvardhan Tikle |
| Designation |
Additional Professor |
| Affiliation |
TNMC and B.Y.L. Charitable Hospital Mumbai |
| Address |
Department of Anesthesia, TNMC and B.Y.L Charitable Hospital, Mumbai 400008
Mumbai
MAHARASHTRA
400008
India |
| Phone |
9892404649 |
| Fax |
|
| Email |
tiklehrshwardhan@gmail.com |
|
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Source of Monetary or Material Support
|
| Nil |
| T.N.M.C. and B.Y.L. Charitable Hospital, Mumbai 400008 |
|
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Primary Sponsor
|
| Name |
T.N.M.C. and B.Y.L. Charitable Hospital. |
| Address |
T.N.M.C. and B.Y.L. Charitable Hospital, Mumbai 400008 |
| Type of Sponsor |
Government medical college |
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
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Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Harshada Daf |
TNMC and BYL Hospital |
3rd floor,Anesthesia Department, College Building,TNMC and BYL Hospital Mumbai 40008
Mumbai
MAHARASHTRA |
7721902019
harshadadaf287@gmail.com |
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee for Academic Research Projets,TNMC, Mumbai400008 |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K400||Bilateral inguinal hernia, with obstruction, without gangrene, (2) ICD-10 Condition: G20||Parkinsons disease, (3) ICD-10 Condition: I119||Hypertensive heart disease withoutheart failure, (4) ICD-10 Condition: I221||Subsequent ST elevation (STEMI) myocardial infarction of inferior wall, (5) ICD-10 Condition: J011||Acute frontal sinusitis, (6) ICD-10 Condition: J980||Diseases of bronchus, not elsewhere classified, (7) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, (8) ICD-10 Condition: E02||Subclinical iodine-deficiency hypothyroidism, (9) ICD-10 Condition: E663||Overweight, (10) ICD-10 Condition: K353||Acute appendicitis with localizedperitonitis, (11) ICD-10 Condition: K746||Other and unspecified cirrhosis ofliver, (12) ICD-10 Condition: N219||Calculus of lower urinary tract, unspecified, (13) ICD-10 Condition: D561||Beta thalassemia, (14) ICD-10 Condition: D500||Iron deficiency anemia secondary to blood loss (chronic), (15) ICD-10 Condition: E109||Type 1 diabetes mellitus without complications, (16) ICD-10 Condition: K210||Gastro-esophageal reflux disease with esophagitis, (17) ICD-10 Condition: W06||Fall from bed, (18) ICD-10 Condition: A150||Tuberculosis of lung, (19) ICD-10 Condition: I702||Atherosclerosis of native arteriesof the extremities, (20) ICD-10 Condition: R05||Cough, |
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Sub Arachnoid Block with Injection Bupivacaine 0.5 Percent Heavy |
Injection Bupivacaine 0.5 percent heavy will be given intrathecally and will look for the motor block sensory block and hemodynamic stability and record it as reference |
| Comparator Agent |
Sub Arachnoid Block with Injection Ropivacaine 0.75 Percent Heavy |
Effect of sub Arachnoid Block with Injection Ropivacaine 0.75 Percent parameters will be compared with Inj.Bupivacaine 0.5% heavy |
| Comparator Agent |
Subarachnoid block with Inj.Levobupivacaine 0.5% heavy |
Effect of sub Arachnoid Block with Injection Levobupivacaine 0..5 Percent parameters will be compared with Injection Bupivacaine 0.5% heavy |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
After obtaining consent for SAB
1) American Society of Anesthesiologist grade I ,II and III well controlled Hypertension/DM and any other cardiac conditions which is not contraindicated for SAB
2) Age between 18 to 75 yrs
3) Patient of either sex
4) Undergoing lower limb and lower abdominal surgery. |
|
| ExclusionCriteria |
| Details |
1)Upper abdominal surgeries (Incision extend above the umbilicus) and Lower segment cesarean section.
2)Pt on LMWH and heparin therapy.
3)Fixed cardiac output disorders like Hypertrophic cardiomyopathy,Mital stenosis and Aortic stenosis.
4)Pre-existing neurological conditions which are waxing and waning in nature like multiple sclerosis, poliomyelitis.
5)Allergic to any components of drug or its complications.
6)Any deformity of spine which can affect the natural spread of drug.
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Method of Generating Random Sequence
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Not Applicable |
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Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Not Applicable |
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Primary Outcome
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| Outcome |
TimePoints |
To compare the subarachnoid block (SAB) characteristics after administration of:
1)Bupivacaine Heavy 0.5%
2)Levobupivacaine Heavy 0.5%
3)Ropivacaine Heavy 0.75%
Specifically, the primary objectives are:
1. Time taken to achieve sensory blockade up to T10 dermatome.
2. Time to onset of motor blockade.
3. Maximum level of block achieved.
4. Duration of sensory and motor blockade.
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Block characteristics will be assessed on 0,5,10,15,20,35,60,90 minutes |
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Secondary Outcome
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| Outcome |
TimePoints |
| Hemodynamic change |
Monitoring of blood pressure systolic blood pressure and diastolic blood pressure at 5,10,15,30 ,60 and 90 minutes |
|
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Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
31/07/2025 |
| 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="0"
Months="6"
Days="0" |
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Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
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Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
“Comparison of Efficacy of Equipotent Bupivacaine Heavy 0.5%, Levobupivacaine Heavy 0.5% and Ropivacaine Heavy 0.75% in Subarachnoid Block (SAB): An Open, Comparative and Randomized Study” Objective: To compare the efficacy and safety of three local anesthetics — Bupivacaine (0.5%), Levobupivacaine (0.5%), and Ropivacaine (0.75%) — when used for subarachnoid block (spinal anesthesia) in lower limb and abdominal surgeries.
Primary Parameters:
Onset of sensory and motor block
Maximum sensory level attained
Duration of motor and sensory block Secondary Parameters: Hemodynamic changes (e.g., hypotension, bradycardia) Side effects Tertiary Parameter: Duration of postoperative analgesia Recruitment Details:
Study Population:
ASA Grade I–III patients (with well-controlled comorbidities)
Age: 18–75 years
Undergoing lower limb or lower abdominal surgeries
Both male and female participants
Exclusion Criteria Include:
Upper abdominal surgeries
Patients on LMWH/heparin
Severe cardiac conditions (e.g., aortic stenosis)
Neurological disorders (e.g., MS)
Allergy to any study drugs
Spinal deformities
Sample Size:
30 patients per group, totaling 90 participants Randomization done using computer-generated numbers Methodology in Brief: Participants divided into 3 groups: Group A: Bupivacaine 0.5% Group B: Levobupivacaine 0.5% Group C: Ropivacaine 0.75% Each patient receives 3 mL of the assigned drug intrathecally. Sensory and motor block assessed at intervals using: Pinprick/temperature test for sensory block Modified Bromage Scale for motor block Hemodynamic parameters and side effects monitored. Postoperative pain assessed using Visual Analog Scale (VAS).
Statistical Analysis:
PSPP software ANOVA, Chi-square, Mann-Whitney U, and t-tests Significance level set at p < 0.05
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