A study to evaluate the safety and effect of Ropin Heavy® injection for spinal anaesthesia in adult subjects

A Multicentre, Open Label, Post Marketing Surveillance Study to Evaluate the Safety and Efficacy of Ropin Heavy® [Ropivacaine Hydrochloride 0.75% (7.5mg/mL) in Dextrose 8% (80mg/mL)] injection for spinal anaesthesia in adult subjects ?

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2022/03/040917

Enrollment

214

Registered

2022-03-08

Start date

Unknown

Completion date

Unknown

Last updated

2024-03-04

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: Ropin Heavy® [Ropivacaine Hydrochloride 0.75% (7.5mg/mL) in Dextrose 8% (80mg/mL)] injection: A single dose of Ropin Heavy® maximum up to 4mL will be administered to the subject through

Eligibility

Inclusion criteria

Inclusion 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 surgeries under spinal anaesthesia of duration =3 hours. 4. Subjects willing to sign informed consent for participation in the study.

Exclusion criteria

Exclusion criteria: 1. Subjects with contraindications for spinal anaesthesia. 2. Subjects receiving treatment with MAO inhibitors, Phenothiazines and Tricyclic antidepressants within 14 days prior to participation in the trial. 3. Subjects with concurrent participation in another clinical trial or any investigational therapy within 30 days prior to signing informed consent. 4. Subjects with suspected inability to comply with the study procedure. 5. Subjects with known hypersensitivity to the investigational medicinal products. 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
1. Incidence of adverse events (AEs) after administration of Study drug till end of study visit. 2. Incidence of serious AEs (SAEs) and serious ADRs (SADRs) after administration of Study drug till end of study visit.Timepoint: 24±6 Hours	—

Secondary

Measure	Time frame
1.Mean time required to reach sensory block up to T10 (Onset) measured by Pinprick method. 2.Mean time to reach peak level of sensory block. 3.Mean time required for two segment regression from peak level of sensory block. 4.Mean duration of sensory block from time of injection to first demand for analgesia. 5.Mean time required for onset of motor block as measured by modified Bromage scale. 6.Mean time required for complete recovery of motor block as measured by modified Bromage scaleTimepoint: 24±6 Hours	—

Measure

Time frame

1.Mean time required to reach sensory block up to T10 (Onset) measured by Pinprick method. 2.Mean time to reach peak level of sensory block. 3.Mean time required for two segment regression from peak level of sensory block. 4.Mean duration of sensory block from time of injection to first demand for analgesia. 5.Mean time required for onset of motor block as measured by modified Bromage scale. 6.Mean time required for complete recovery of motor block as measured by modified Bromage scaleTimepoint: 24±6 Hours

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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