| CTRI Number |
CTRI/2022/03/040917 [Registered on: 08/03/2022] Trial Registered Prospectively |
| Last Modified On: |
20/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to evaluate the safety and effect of Ropin Heavy® injection for spinal anaesthesia in adult subjects |
|
Scientific Title of Study
|
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†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BCR-RPD-02 Version 1.0 dated 27 Sep 2021 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bharati Kondwilkar |
| Designation |
Sponsors Principal Investigator |
| Affiliation |
Neon Laboratories Ltd |
| Address |
140 Damji Shamji Industrial Complex Mahakali Caves Rd. Andheri East
Mumbai
Mumbai
MAHARASHTRA
400093
India |
| Phone |
02268307000 |
| Fax |
02226873502 |
| Email |
bkneon2019@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neeta Joshi |
| Designation |
Manager Formulation and Development |
| Affiliation |
Neon Laboratories Ltd |
| Address |
140 Damji Shamji Industrial Complex Mahakali Caves Rd. Andheri East
Mumbai
Mumbai
MAHARASHTRA
400093
India |
| Phone |
02268307000 |
| Fax |
02226873502 |
| Email |
neeta@pl.neongroup.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neeta Nargundkar |
| Designation |
Managing Director |
| Affiliation |
Biosphere Clinical Research Pvt.Ltd |
| Address |
Office No. 02, 03 and 04, 2nd Floor Highland Corporate Center, Kapurbawdi
Junction,
Thane
Thane
MAHARASHTRA
400607
India |
| Phone |
02241006794 |
| Fax |
|
| Email |
drneeta@biospherecro.com |
|
|
Source of Monetary or Material Support
|
| Neon Laboratories Ltd 140, DamjiShamji Industrial Complex, Mahakali Caves Rd.,
Andheri(East), Mumbai-400093, Maharashtra, India. |
|
|
Primary Sponsor
|
| Name |
Neon Laboratories Ltd |
| Address |
140, Damji Shamji Industrial Complex, Mahakali Caves Rd., Andheri(East), Mumbai-400093, Maharashtra, India.
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 13 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Prajwal Patel H S |
Adichunchanagiri Inst itute of Medical Sciences, |
Department of Anaesthesiology,Nagamangala
Taluk, Dist, B.G
Nagara, Mandya(Dt)-
571448,Karnataka
Mandya
KARNATAKA |
9886787773
prajwal.patel83@gmail.com |
| Dr Pradnya Bhalerao |
B.J. Govt. Medical College and Sassoon General Hospital |
Department of
Anaestheiology,1st Floor
,Block 11, Jai Prakash
Narayan Road, Near Pune
Railway Station, Pune-411001, Maharashtra,
India
Pune
MAHARASHTRA |
8806664773
dr.pradnyabhalerao@gmail.com |
| Dr Megha G H |
Basweshwara Medical College & Hospital |
Deapartment of Anaestheiology, S.J.M Campus, NH-4, Chitradurga-577502,
Chitradurga
KARNATAKA |
9480599736
drmegha.gh@gmail.com |
| DrVikas Singh |
Charak Hospital and Research Centre |
Department of Critical
Care &
Anaesthesia,Hardoi
Road,Dubagga,
Lucknow-226003, Uttar
Pradesh,India
Lucknow
UTTAR PRADESH |
7880691784
rkslko.09@gmail.com |
| Dr Hirak Biswas |
College of Medicine & Sagore Dutta Hospital |
Department of Anaestheiology, 578, B.T. Road, Kamahati, Kolkata-700058
Kolkata
WEST BENGAL |
9531575320
hirak.biswas7@gmail.com |
| Dr Vrishali Ankalwar |
Government Medical College Nagpur |
Department of
Anaesthesia,Ground
floor,
OT-G,Medical Square, Hanuman Nagar, Nagpur-440003
Nagpur
MAHARASHTRA |
9881113317
vriankalwar@yahoo.com |
| Dr Usha Badole |
Grant Medical College & Sir JJ Hospital |
Department of
Anaesthesiology, 6th Floor
,J J Marg,
Nagpada, Mumbai
Central, Mumbai-400008
Maharashtra
Mumbai
MAHARASHTRA
Mumbai
MAHARASHTRA |
9869624637
usharatan28@gmail.com |
| Dr H G Manjunatha |
Mysore Medical College and Research Institute, KR Hospital |
Department of
Anaesthesia,
Irwin Road, Mysore
,Karnataka, India
-570021
Mysore
KARNATAKA |
9448054368
drhgmanjunath@hotmail.com |
| Dr Geetanjali Akhade |
Noble Hospital and Research Centre |
Department of Anaestheiology,
153,
Magaryatta City Road,
Pune-411013,
Maharashtra, India.
Pune
MAHARASHTRA |
9850820538
dangat.geeta@gmail.com |
| Dr Maroti Gaikwad |
PCMCs PGI Yashwantrao Chavan Memorial Hospital |
Department Of
Anaesthesia,Sant
Tukaram Nagar, Near
D.Y.Patil Medical
College Vallabhnagar
,Pimpri, Pune - 411018,
Maharashtra, India
Pune
MAHARASHTRA |
9993226907
mrg20767@gmail.com |
| Dr Manish Magan |
Pushpanjali Hospital and Research Centre Pvt. Ltd |
Department of clinical Research,Ground Floor,Pushpanjali Palace, Near Delhi Gate Agra -282002 Uttar Pradesh
Agra
UTTAR PRADESH |
6398425182
drmanishmagan@yahoo.com |
| Dr Sangita Kulkarni |
Saideep Healthcare & Research Pvt. Ltd |
Department of Anaestheiology, Viraj Estate, Behind Yashwant Colony, Near DSP Chowk, Ahmednagar-414003, Maharashtra, India
Ahmadnagar
MAHARASHTRA |
9822118874
ksangini@gmail.com |
| Dr Jagdish Hegde |
Sparsh Super Speciality Hospital |
Department of
Anaesthesiology,
4/1, Tumkur Road,
Yeshwantpur, Bangalore-
560022
Bangalore
KARNATAKA |
9954275066
jagguhegde@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 13 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of BJ Govt Medical College and Sassoon General Hospital Pune |
Approved |
| Institutional Ethics Committee, Adichunchanagiri Institute of Medical Sciences, |
Approved |
| Institutional Ethics Committee, Basweshwara Medical College & Hospital,Chitradurga |
Submittted/Under Review |
| Institutional Ethics Committee, Charak Hospital and Research Centre Lucknow |
Approved |
| Institutional Ethics Committee, College of Medicine & Sagore Dutta Hospital, Kolkata |
Approved |
| Institutional Ethics Committee, GGMC and Sir JJ Hospital Mumbai |
Approved |
| Institutional Ethics Committee, Government Medical College and Hospital Nagpur |
Submittted/Under Review |
| Institutional Ethics Committee, Mysore Medical College & Research Institute, Mysore |
Approved |
| Institutional Ethics Committee, Saideep Hospital, |
Approved |
| Institutional Ethics Committee, Sparsh Hospital for Advanced Surgeries Bangalore |
Submittted/Under Review |
| Institutional Ethics Committee, Yashwantrao Chavan Memorial Hospital Pune |
Approved |
| Noble Hospital Institutional Ethics Committee |
Approved |
| Pushpanjali Hospital Ethics Committee, |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 3||Administration, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
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 intrathecal route at L3-L4 or L4-L5 intervertebral level under aseptic conditions |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
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. |
|
| ExclusionCriteria |
| Details |
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. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
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. |
24±6 Hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
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 scale |
24±6 Hours |
|
|
Target Sample Size
|
Total Sample Size="214"
Sample Size from India="214"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
25/03/2022 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="10"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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. |