| CTRI Number |
CTRI/2026/03/106760 [Registered on: 23/03/2026] Trial Registered Prospectively |
| Last Modified On: |
13/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
COMPARING EFFECTIVENESS OF TWO DIFFERENT LOCAL ANAESTHETICS AGENTS IN ORTHOPEDIC SURGERIES |
|
Scientific Title of Study
|
COMPARISON ON EFFICACY OF INTRATHECAL 0.5 PERCENT HYPERBARIC BUPIVACAINE VERSUS 0.5 PERCENT HYPERBARIC LEVOBUPIVACAINE WITH ADDITIVE BUPRENORPHINE 100mcg IN BOTH FOR ORTHOPAEDIC LOWER LIMB SURGERY : A RANDOMIZED CLINICAL 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 |
DR ASHA MALLINATH INDUR |
| Designation |
PG RESIDENT |
| Affiliation |
BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE |
| Address |
BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE
BANGALORE
SRI VENKATADHRI NILAYA
186/1
Chamrajpet,4th MAIN
BANGALORE
Bangalore
KARNATAKA
560002
India |
| Phone |
7204817670 |
| Fax |
|
| Email |
ashaindur09@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SAMUDYATHA T J |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
Bangalore MEDICAL COLLEGE AND RESERACH INSTITUTE |
| Address |
BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE
BANGALORE
Bangalore
KARNATAKA
560002
India |
| Phone |
9686216626 |
| Fax |
|
| Email |
drsamudyatha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SAMUDYATHA T J |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
BENGALURU MEDICAL COLLEGE AND RESEARCH INSTITUTE |
| Address |
BENGALURU MEDICAL COLLEGE AND RESEARCH INSTITUTE , BENGALURU
Bangalore
KARNATAKA
560002
India |
| Phone |
9686216626 |
| Fax |
|
| Email |
drsamudyatha@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DR ASHA MALLINATH INDUR |
| Address |
BANGLORE MEDICAL COLLEGE AND RESEARCH INSTITUTE, BANGLORE |
| 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 |
| DR ASHA MALLINATH INDUR |
DEPARTMENT OF ANAESTHESIA,3RD FLOOR, MPB BUILDING,VICTORIA HOSPITAL |
BANGLORE MEDICAL COLLEGE AND RESEAARCH INSTITUTE
Bangalore
KARNATAKA |
7204817670
ashaindur09@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE OF BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S70-S79||Injuries to the hip and thigh, (2) ICD-10 Condition: S80-S89||Injuries to the knee and lower leg, (3) ICD-10 Condition: S90-S99||Injuries to the ankle and foot, (4) ICD-10 Condition: M16||Osteoarthritis of hip, (5) ICD-10 Condition: M17||Osteoarthritis of knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
0.5 PERCENT HYPERBARIC BUPIVACAINE WITH ADDITIVE BUPRENORPHINE 100MCG |
ASSESSING LEVEL OF SENSORY AND MOTOR BLOCAKADE . POST OP PAIN INTENSITY SCORES . DURATION OF ANALGESIA
Dose - 3.2ml route - intrathecal , frequency- given once at the beginning surgery, total duration of intervention- delivery of drug to 24 hr post surgery |
| Intervention |
0.5 PERCENT HYPERBARIC LEVOBUPIVACAINE WITH ADDITIVE BUPRENORPHINE 100MCG |
ASSESSING LEVEL OF SENSORY AND MOTOR BLOCAKADE . POST OP PAIN INTENSITY SCORES . DURATION OF ANALGESIA Dose - 3.2ml route - intrathecal , frequency- given once at the beginning surgery, total duration of intervention- delivery of drug to 24 hr post surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Adult patients aged 18 to 60 years of either sex.2 Patients scheduled for elective orthopedic lower limb surgeries under subarachnoid block. 3 Patients classified as American Society of Anesthesiologists (ASA) physical status I or II. 4 Patients who are willing to participate in the study and provide voluntary written informed consent prior to enrollment |
|
| ExclusionCriteria |
| Details |
1 Patients with a known history of hypersensitivity or allergy to local anesthetic
agents or opioids. 2 Patients with absolute contraindications to spinal anesthesia, including but not limited to raised intracranial pressure, severe hypovolemia, bleeding diathesis, coagulopathy, infection at the injection site, pre-existing neurological deficits, or significant spinal deformities. 3 Patients with neurological or psychiatric disorders, or those with communication difficulties that may interfere with accurate assessment of sensory block, motor
block, or pain scores. 4 Patients classified as ASA physical status III, IV, or V, due to increased perioperative risk and potential confounding of outcomes. 5 Patients aged below 18 years or above 60 years, to maintain homogeneity of the study population and minimize age-related physiological variability. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
ONSET OF SENSORY BLOCK
TIME TO ACHIEVE MAXIMUM SENSORY BLOCK
TWO SEGMENT SENSORY REGRESSION TIME
DURATION OF SENSORY BLOCK
ONSET AND DURATION OF MOTOR BLOCK
TOTAL DURATION OF ANALGESIA |
2MINUTES
4MINUTES
6MINUTES
8MINUTES
10MINUTES
15MINUTES
20MINUTES
25MINUTES
30MINUTES
60MINUTES
90MINUTES
120MINUTES
150MINUTES
180MINUTES |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| HEMODYNAMIC MONITORING - HEART RATE BLODD PRESSURE AND ADVERSE EVENTS |
2 MINUTE
4 MINUTE
6 MINUTE
8 MINUTE
10 MINUTE
15 MINUTE
20 MINUTE
25 MINUTE
30 MINUTE
60 MINUTE
90 MINUTE
120 MINUTE
150 MINUTE
180 MINUTE |
| TIME TAKEN FOR 2 SEGMENT REGRESSION , TOTAL DURATION OF SENSORY AND MOTAL BLOCKADE , POST OP HEMODYNAMIC STABILITY , TIME TAKEN FOR FIRST ANAGESIA |
2 HOURS
4 HOURS
6 HOURS
12 HOURS
24 HOURS |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/04/2026 |
| 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 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
|
In my study when we compared intrathecal 0.5 percent hyperbaric bupivacaine versus 0.5 percent hyperbaric levobupivacaine with additive buprenorphine 100mcg for lower limb orthopedic surgery.We found levobupivacaine gave better hemodynamic stability, extended time for first rescue analgesia, improved post operative pain score and reduced requirement of additional analgesics while bupivacaine is comparable with levobupivacaine it provides prolonged duration of motor blockade which may delay early ambulation |