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

Not Applicable

Completed

• Conditions: Administration,

• Registration Number: CTRI/2022/03/040917
• Lead Sponsor: Neon Laboratories Ltd

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-25
• Last Update Posted: 2024-02-20

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 214

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.

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Incidence of adverse events (AEs) after administration of Study drug till end of study visit.	24±6 Hours
2. Incidence of serious AEs (SAEs) and serious ADRs (SADRs) after administration of Study drug till end of study visit.	24±6 Hours

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (13)

Adichunchanagiri Inst itute of Medical Sciences,; 🇮🇳 Mandya, KARNATAKA, India

B.J. Govt. Medical College and Sassoon General Hospital; 🇮🇳 Pune, MAHARASHTRA, India

Basweshwara Medical College & Hospital; 🇮🇳 Chitradurga, KARNATAKA, India

Charak Hospital and Research Centre; 🇮🇳 Lucknow, UTTAR PRADESH, India

College of Medicine & Sagore Dutta Hospital; 🇮🇳 Kolkata, WEST BENGAL, India

Government Medical College Nagpur; 🇮🇳 Nagpur, MAHARASHTRA, India

Grant Medical College & Sir JJ Hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

Mysore Medical College and Research Institute, KR Hospital; 🇮🇳 Mysore, KARNATAKA, India

Noble Hospital and Research Centre; 🇮🇳 Pune, MAHARASHTRA, India

PCMCs PGI Yashwantrao Chavan Memorial Hospital; 🇮🇳 Pune, MAHARASHTRA, India

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Adichunchanagiri Inst itute of Medical Sciences,

🇮🇳Mandya, KARNATAKA, India

Dr Prajwal Patel H S

Principal investigator

9886787773

prajwal.patel83@gmail.com