| CTRI Number |
CTRI/2020/07/026903 [Registered on: 29/07/2020] Trial Registered Prospectively |
| Last Modified On: |
10/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
evaluate the safety and effectiveness of Fixed Dose Combinations of Bupivacaine and Fentanyl epidural injection in post-operative and labour pain |
|
Scientific Title of Study
|
A prospective, open label, randomized, non-comparative, multicentric study to evaluate the safety and effectiveness of Fixed Dose Combinations of Bupivacaine and Fentanyl epidural injection in post-operative and labour pain |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CT/55/01/18 version 2 dated 16 Apr 2019 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Amit Bhalla |
| Designation |
Senior General Manager |
| Affiliation |
Troikaa Pharmaceuticals Limited |
| Address |
Troikaa Pharmaceuticals Limited Commerce House 1 Satya marg bodakdev
Ahmadabad
GUJARAT
380054
India |
| Phone |
07926856242 |
| Fax |
|
| Email |
amitbhalla@troikaapharma.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amit Bhalla |
| Designation |
Senior General Manager |
| Affiliation |
Troikaa Pharmaceuticals Limited |
| Address |
Troikaa Pharmaceuticals Limited Commerce House 1 Satya marg bodakdev
GUJARAT
380054
India |
| Phone |
07926856242 |
| Fax |
|
| Email |
amitbhalla@troikaapharma.com |
|
Details of Contact Person
Public Query
|
| Name |
Pratik Shah |
| Designation |
Project Manager |
| Affiliation |
Troikaa Pharmaceuticals Limited |
| Address |
Troikaa Pharmaceuticals Limited Commerce House 1 Satya marg bodakdev
Ahmadabad
GUJARAT
380054
India |
| Phone |
07926856242 |
| Fax |
|
| Email |
pratikshah@troikaapharma.com |
|
|
Source of Monetary or Material Support
|
| Troikaa Pharmaceuticals Ltd |
|
|
Primary Sponsor
|
| Name |
Troikaa Pharmaceuticals Ltd |
| Address |
Troikaa Pharmaceuticals Limited Commerce House 1 Satya marg bodakdev Ahmedabad |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 13 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Usha Bansal |
Apollo Hospitals International |
ground floor department of anesthesia Plot no la GIDC estate Bhat Gandhinagar
Gandhinagar
GUJARAT |
07966701800
vbansal89@yahoo.com |
| Dr Sumathi Shankar |
Apollo Hospitals International Ltd |
ground floor dept Of anesthesiology 21 Greams Lane Off Greams Road
Chennai
TAMIL NADU |
9840424256
hilda.s@apolloari.com |
| Dr Yogesh Tank |
Asian Bariatrics |
S No 235/2 B/s Tata Motors Showroom Opposite Rajpath Club S.G.Highway Bodakdev
Ahmadabad
GUJARAT |
9904468245
nimeshp89@outlook.com |
| Dr Valsamma Abraham |
Christian Medical College and Hospital |
Christian Medical College & Hospital Ludhiana
Ludhiana
PUNJAB |
9915326547
manishathakur774@gmail.com |
| Dr Apurva Agarwal |
G.S.V.M Medical college |
Swaroop Nagar Kanpur
Kanpur Nagar
UTTAR PRADESH |
7052515253
lpscardioresearch@gmail.com |
| Dr Chiranjib Bhattacharya |
IPGME & R, SSKM hospital |
2nd floor dept Of anesthesiology
244, AJC Bose road
Kolkata
WEST BENGAL |
9433508030
bhattach1@Yahoo.com |
| Dr Satyen Parida |
Jawaharlal Institute of Postgraduate Medical Education and Research JIPMER |
Dhanvantri Nagar Puducherry
Pondicherry
PONDICHERRY |
9940973502
jipmersatyen@gmail.com |
| Dr Manjunath Patil |
KLES Dr PrabhakarKore Hospital |
J. N. Medical college Belgaum Belagavi
Belgaum
KARNATAKA |
9964403640
GenesisResearchkolhapur@gmail.com |
| Dr Manjunath H G |
Mysore medical college and research institute |
K R hospital Irwin road Mysore
Mysore
KARNATAKA |
9481574797
sudha06.raj@gmail.com |
| Dr Amlendu Yadav |
PGIMER and DR RML Hospital |
New Delhi
New Delhi
DELHI |
9711315438
yadavamlendu@yahoo.co.in |
| Dr Vipul Patel |
Sanjivani super speciality hospitals |
1 Uday park Nr Sunrise park Vastrapur
Ahmadabad
GUJARAT |
9904468245
nimeshp89@outlook.com |
| Dr Vengala Sreelatha |
Sidhartha Medical College |
Ring road Gunadala
Krishna
ANDHRA PRADESH |
08662450390
yashodhar.m@gmail.com |
| Dr Prakash B C |
Sri Siddhartha Medical College |
B.H. Road Agalkote Tumakuru
Tumkur
KARNATAKA |
9481574797
sudha06.raj@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 13 |
| Name of Committee |
Approval Status |
| Ethics Committee GSVM Medical college |
Submittted/Under Review |
| Institute Ethics Committee JIPMER |
Submittted/Under Review |
| Institute Ethics Committee Siddhartha Medical College |
Submittted/Under Review |
| Institutional Ethics committee sri siddhartha medical college |
Submittted/Under Review |
| Institutional Ethics Committee Apollo hospital ahmedabad |
Submittted/Under Review |
| Institutional Ethics committee Asian Bariatrics |
Submittted/Under Review |
| Institutional Ethics committee christian medical college |
Approved |
| Institutional Ethics committee clinical studies Apollo Hospitals Chennai |
Approved |
| Institutional Ethics committee KLES Dr Prabhakar Kore Hospital |
Submittted/Under Review |
| Institutional Ethics committee Mysore medical college and research institute |
Submittted/Under Review |
| Institutional Ethics committee PGIMER & DR RML Hospital |
Submittted/Under Review |
| IPGME & R research oversight committee |
Submittted/Under Review |
| Sanjivani hospital ethics committee |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
fdc of Bupivacaine plus fentanyl citrate |
Bupivacaine Hydrochloride 1.25mg/ml and Fentanyl Citrate 2mcg/ml single dose via epidural route
Bupivacaine Hydrochloride 1 mg/ml and Fentanyl Citrate 2 mcg/ml single dose via epidural route |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA Physical Status Class I or II
Patients undergoing elective surgery with
a. A plan to have epidural catheter for analgesia.
b. If patients are female of childbearing potential: non-pregnant (supported by negative urine pregnancy test at screening), non-lactating and willing to maintain reliable birth control throughout the study
Parturient in active labour with:
a. A cervical dilation of 3–6 cm requesting epidural analgesia.
b. Parturient having full-term live fetus, without any complications. |
|
| ExclusionCriteria |
| Details |
Recent (within last 6 months) history of thromboembolic event e.g. Pulmonary embolism, deep vein thrombosis, superficial thrombophlebitis treated surgically
Criteria includes multiple or preterm gestation pregnancies or weight >130 Kg
Anticipated difficultly intubation
Any contraindication for epidural catheter placement
Hepatic impairment (SGPT/OT > 3 times ULN) or renal impairment (creatinine > 2 mg/dL)
Known hypersensitivity to bupivacaine, fentanyl or diclofenac
Presence of or susceptibility to respiratory depression
Hypovolemia or complete heart block |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Proportion of patients who required rescue analgesia
Mean change in pain intensity on VAS at 30 and 45 minutes compared to baseline |
VAS at 30 and 45 minutes compared to baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Onset of analgesia
Percentage of patients requiring rescue analgesia
Change in pain intensity on VAS at 60, 120, 180 & 240 minutes compared to baseline
Incidence of severe respiratory depression and discontinuation of study treatment |
VAS at 60 120 180 and 240 min compared to baseline |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
31/07/2020 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Other (Terminated) |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Combined use of the Bupivacaine and Fentanyl Citrate in the treatment of post-operative pain and in labour pain is well established in India. There are number of published Clinical Studies concluding the effectiveness and safety of combined administration of Bupivacaine 1.25 mg/ml + Fentanyl Citrate 2 μg/ml as Epidural Injection, by academic institutions in India, for the control of post-operative pain in more than 228 patients collectively and for the control of labour pain in more than 170 parturient women collectively. Moreover, the fixed dose combination of the Bupivacaine + Fentanyl Citrate is already approved in United Kingdom, New Zealand and Switzerland since 5 to 10 years, for epidural analgesia during labour and post-operative pain, by administration as bolus, continuous infusion as well as intermittent boluses. Based on this information, Troikaa has proposed the clinical trial of fixed dose combination of Bupivacaine + Fentanyl Citrate solution for epidural injection. |