A Clinical study to compare the effect and safety of Ropivacaine Hydrochloride in dextrose and Bupivacaine Hydrochloride in dextrose injection in lower limb orthopaedic surgeries under spinal anaesthesia.

A Phase III, Multicentre, Randomized, Double Blind, Parallel group, Comparative Clinical Study to evaluate Efficacy and Safety of Ropivacaine Hydrochloride 0.75% (7.5mg/mL) in Dextrose 8% (80mg/mL) injection compared to Bupivacaine Hydrochloride 0.5% (5mg/mL) in Dextrose 8% (80mg/mL) injection for subjects undergoing lower limb orthopaedic surgeries under spinal anaesthesia.â??

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/02/023372

Enrollment

230

Registered

2020-02-17

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: 3- Administration

Interventions

Intervention1: Ropivacaine Hydrochloride 0.75% (7.5mg/mL) in Dextrose 8%(80mg/mL) injection.: A single dose of maximum up to 3 mL will beadministered to the subject through intrathecal route at L3-L4

Eligibility

Inclusion criteria

Inclusion criteria: To be eligible for the study, Subjects must meet all the following criteria: 1.Male and female subjects of age between 18 to 65 years (both inclusive). 2.Subjects belonging to ASA Grade I to II. 3.Subjects undergoing lower limb orthopaedic surgeries of duration 4.Subjects willing to sign informed consent for participation in the study.

Exclusion criteria

Exclusion criteria: Subjects will be excluded from the study for any of the following reasons: 1.Subjects with known hypersensitivity to the investigational medicinal products. 2.Subjects with contraindications for spinal anaesthesia. 3.Subjects receiving treatment with MAO inhibitors, Phenothiazines and Tricyclic antidepressants within 14 days prior to participation in the trial. 4.Subjects with concurrent participation in another clinical trial or any investigational therapy within 30 days prior to signing informed consent. 5.Subjects with suspected inability to comply with the study procedure. 6.Female subjects who are pregnant or lactating. 7.Female subjects who are not ready to use acceptable contraceptive methods during the course of study.

Design outcomes

Primary

Measure	Time frame
Mean difference in 1. Time required to reach sensory block up to T10. 2. Peak level of sensory block. 3. Time taken for two segment regression from peak level of sensory block. 4.Total duration of sensory block from time of injection to first demand for analgesia. 5. Time required for onset and complete recovery of motor block as measured by modified Bromage scale. 6. Time required for first micturition,achieve independent mobility. Timepoint: 48Â±6 Hours	—

Measure

Time frame

Mean difference in 1. Time required to reach sensory block up to T10. 2. Peak level of sensory block. 3. Time taken for two segment regression from peak level of sensory block. 4.Total duration of sensory block from time of injection to first demand for analgesia. 5. Time required for onset and complete recovery of motor block as measured by modified Bromage scale. 6. Time required for first micturition,achieve independent mobility. Timepoint: 48Â±6 Hours

—

Secondary

Measure	Time frame
1. Mean change in vital parameters (Heart Rate, BP, Respiratory rate& SPO2). 2.The assessment of safety will be based on the frequency of adverse events and change in laboratory values. Timepoint: 48Â±6 Hours	—

Countries

India

Contacts

Public ContactDr Neeta Nargundkar

Neon Laboratories Ltd

neeta@pl.neongroup.com02268307000

Outcome results

None listed

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