COMPARING EFFECTIVENESS OF TWO DIFFERENT LOCAL ANAESTHETICS AGENTS IN ORTHOPEDIC SURGERIES

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 - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/03/106760

Enrollment

Registered

2026-03-23

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: S70-S79- Injuries to the hip and thigh Health Condition 2: S80-S89- Injuries to the knee and lower leg Health Condition 3: S90-S99- Injuries to the ankle and foot Health Condition 4: M16- Osteoarthritis of hip Health Condition 5: M17- Osteoarthritis of knee

Interventions

Intervention1: 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 -

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
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 ANALGESIATimepoint: 2MINUTES 4MINUTES 6MINUTES 8MINUTES 10MINUTES 15MINUTES 20MINUTES 25MINUTES 30MINUTES 60MINUTES 90MINUTES 120MINUTES 150MINUTES 180MINUTES	—

Secondary

Measure	Time frame
HEMODYNAMIC MONITORING - HEART RATE BLODD PRESSURE AND ADVERSE EVENTSTimepoint: 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 ANAGESIATimepoint: 2 HOURS 4 HOURS 6 HOURS 12 HOURS 24 HOURS	—

Measure

Time frame

HEMODYNAMIC MONITORING - HEART RATE BLODD PRESSURE AND ADVERSE EVENTSTimepoint: 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 ANAGESIATimepoint: 2 HOURS 4 HOURS 6 HOURS 12 HOURS 24 HOURS

—

Countries

India

Contacts

Public ContactDR SAMUDYATHA T J

Bangalore MEDICAL COLLEGE AND RESERACH INSTITUTE

drsamudyatha@gmail.com9686216626

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Apr 4, 2026