comparison of newly approved local anaesthetic drugs like levobupivacine(0.5%) ,Ropivacaine(0.75%) with standard Bupivacaine(0.5%) along with fentanyl in spinal anaesthesia for surgeries in legs.

Comparison of block characteristics of Hyperbaric Bupivacaine (0.5%), Hyperbaric Levobupivaicaine (0.5%) and Hyperbaric Ropivaicaine (0.75%) with Fentanyl as adjuvant in subarachnoid block for elective lower limb surgeries-A Double blinded randomized controlled trial.

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/01/048895

Enrollment

Registered

2023-01-11

Start date

Unknown

Completion date

Unknown

Last updated

2023-02-06

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

Conditions

Health Condition 1: I10- Essential (primary) hypertension Health Condition 2: J453- Mild persistent asthma Health Condition 3: E018- Other iodine-deficiency related thyroid disorders and allied conditions Health Condition 4: E119- Type 2 diabetes mellitus without complications Health Condition 5: S829- Unspecified fracture of lower leg

Interventions

Intervention1: Hyperbaric Ropivaicaine (0.75%) with Fentanyl: 2.5ml of 0.75% Hyperbaric Ropivacaine + 0.5 ml of Fentanyl(25 mcg). Duration of study will extend 24 hours post administration of drug. In

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients belonging to ASA I & II 2. Aged between 18 & 65 years 3. Patient undergoing elective lower limb surgeries.

Exclusion criteria

Exclusion criteria: 1. Contraindications to central neuraxial blockade. 2. Pregnant women. 3. Allergy to local anaesthetics.

Design outcomes

Primary

Measure	Time frame
Time taken for onset of sensory blockade to T10Timepoint: onset of sensory blockade will be assessed every 1 minute after administration of drug till it reaches T10	—

Secondary

Measure	Time frame
adverse effects ( hypotension,bradycardia,urinary retention,pruritus)Timepoint: duration of study and 24 hours postopeatively;duration of motor blockadeTimepoint: 140 minutes;hemodynamic parameters(Heart rate,MAP,oxygen saturation)Timepoint: entire duration of study;peak sensory levelTimepoint: 12 minutes;Time taken for onset of complete motor block (Modified Bromage score-3).Timepoint: 10 minutes;time taken for two point dermatomal regressionTimepoint: 158 minutes;time taken to reach peak sensory levelTimepoint: 13 minutes	—

Measure

Time frame

adverse effects ( hypotension,bradycardia,urinary retention,pruritus)Timepoint: duration of study and 24 hours postopeatively;duration of motor blockadeTimepoint: 140 minutes;hemodynamic parameters(Heart rate,MAP,oxygen saturation)Timepoint: entire duration of study;peak sensory levelTimepoint: 12 minutes;Time taken for onset of complete motor block (Modified Bromage score-3).Timepoint: 10 minutes;time taken for two point dermatomal regressionTimepoint: 158 minutes;time taken to reach peak sensory levelTimepoint: 13 minutes

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Countries

India

Contacts

Public ContactDr Sivakumar S

Pondicherry Institute of Medical Sciences

lydianithian142@gmail.com9944060676

Outcome results

None listed

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