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 subjectsâ€
Trial Snapshot
- Phase
- Unknown
- Status
- Completed
- Sponsor
- Enrollment
- 214
- Locations
- 13
- Primary Endpoint
- 1. Incidence of adverse events (AEs) after administration of Study drug till end of study visit.
Study Overview
Brief Summary
This study is 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. Total 214 subjects will be enrolled in the study.
The investigator will assess the subject for safety as well as efficacy parameters as per protocol defined time points from the time of administration of spinal anaesthesia till end of study visit/ Visit 4/ 24 ±6 hours after administration of IP or at the time of discharge whichever is earlier
Primary Endpoints:
Incidence rate of adverse events (AEs) after administration of Study drug till end of study visit.
Incidence rates of serious AEs (SAEs) and serious ADRs (SADRs) after administration of Study drug till end of study visit.
Secondary Endpoints:
Mean time required to reach sensory block up to T10 (Onset) measured by Pinprick method.
Mean time to reach peak level of sensory block.
Mean time required for two segment regression from peak level of sensory block.
Mean duration of sensory block from time of injection to first demand for analgesia.
Mean time required for onset of motor block as measured by modified Bromage scale.
Mean time required for complete recovery of motor block as measured by modified Bromage scale.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Male and female subjects of age between 18 to 65 years (both inclusive).
- •Subjects belonging to ASA Grade I to II.
- •Subjects undergoing surgeries under spinal anaesthesia of duration ≤3 hours.
- •Subjects willing to sign informed consent for participation in the study.
Exclusion Criteria
- •Subjects with contraindications for spinal anaesthesia.
- •Subjects receiving treatment with MAO inhibitors, Phenothiazines and Tricyclic antidepressants within 14 days prior to participation in the trial.
- •Subjects with suspected inability to comply with the study procedure.
- •Subjects with known hypersensitivity to the investigational medicinal products.
- •Female subjects who are pregnant or lactating.
- •Female subjects who are not ready to use acceptable contraceptive methods during the course of study.
Outcomes
Primary Outcomes
1. Incidence of adverse events (AEs) after administration of Study drug till end of study visit.
Time Frame: 24±6 Hours
2. Incidence of serious AEs (SAEs) and serious ADRs (SADRs) after administration of Study drug till end of study visit.
Time Frame: 24±6 Hours
Secondary Outcomes
- 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.)