CTRI/2019/09/021200 [Registered on: 12/09/2019] Trial Registered Prospectively
Last Modified On:
30/05/2022
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Surgical/Anesthesia
Study Design
Randomized, Parallel Group Trial
Public Title of Study
A clinical trial to study the Effect and Safety of the Ropivacaine Readyfusor 2mg/ml as a continuous surgical site infusion device with device available in market for the Treatment of Post-Surgical Pain in lower abdominal surgeries.
Scientific Title of Study
A Randomized, Open-label, Prospective, Comparative, Multi-centre, Parallel group, Active controlled, Phase III Study to Evaluate the Efficacy and Safety of the Ropivacaine Readyfusor 2mg/ml versus Ropivacaine Balloon Pump Infusor 2mg/ml as a continuous surgical site infusion for the Treatment of Post-Surgical Pain in lower abdominal laparotomy
Trial Acronym
Secondary IDs if Any
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Jaideep Gogtay
Designation
Chief Medical Officer
Affiliation
Cipla Ltd.
Address
Cipla Ltd. Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel
Department of Anaesthesiology
Apollo Hospitals, Jubilee Hills
Hyderabad-500096, Telangana, India Hyderabad TELANGANA
9701002787
drshekhargreddy@gmail.com
Dr Pradnya Bhalerao
B J Medical College and Sassoon General Hospital
Associate Professor
Department of Anesthesiology,
B J Medical College and Sassoon General Hospital, Near Railway Station, Jai Prakash Narayan Road, Pune, Maharashtra 411001 Pune MAHARASHTRA
8806664773
dr.pradnyabhalerao@gmail.com
Dr Naresh Tirpude
Government Medical College and Hospital Nagpur
Professor & Head
Department of Anesthesiology,
Government Medical College and Hospital, Medical Chowk, Hanuman Nagar, 440009 Nagpur MAHARASHTRA
9823361099
ngtirpude@yahoo.co.in
Dr Apurva Agarwal
GSVM Medical college
Department of Anesthesiology
Ganesh Shankar Vidyarthi Memorial Medical College, Swaroop Nagar, Kanpur, 208002 Kanpur Nagar UTTAR PRADESH
9415368678
drapurva.agarwal@gmail.com
Dr Swati
Indira Gandhi Institute of Medical Science
Department of Anesthesiology,
Indira Gandhi Institute of Medical Science, Sheikhpura, Patna-800014, Bihar India
Patna BIHAR
8544413241
deepakswat@yahoo.com
Dr Sarbari Swaika
Institute of Post Graduate Medical Education and Research SSKM Hospital
Professor,
Dept. of Anaesthesiology, Critical Care
In-Charge, CCU & Anaesthesiology, Level I Trauma Care Center
Institute of Post Graduate Medical Education & Research, SSKM Hospital.
Kolkata. Kolkata WEST BENGAL
9434021722
dr.s.swaika@gmail.com
Dr Gurudatt C L
JSS Hospital
Professor & HOD,
Department of Anaesthesiology
JSS Hospital, M G Road Mysore-570004, Karnataka, India Mysore KARNATAKA
9845312311
dattguru55@gmail.com
Dr Shashikala TK
K.R Hospital, Mysore Medical College & Research Institute Mysore
Professor
Department of Anesthesiology,
K.R Hospital, Mysore Medical College & Research Institute Mysore, Karnataka-570001 Mysore KARNATAKA
9148650639
drshi72@gmail.com
Dr Vasanti Kelkar
Mahatma Gandhi Mission’s Medical College & Hospital
Associate Professor Department of Anesthesiology
MGM Medical College and Hospital
N-6 Cidco, Aurangabad – 431003
Maharashtra, India. Aurangabad MAHARASHTRA
9370668196
vasantikelkar70@gmail.com
Dr Sushmita Bhattachrya
Peerless Hospitex Hospital and research center Ltd
Clinical Director, Anesthesiology, Peerless Hospitex Hospital and research center Ltd,360, Panchasayar, Kolkata 700094, WB, India Kolkata WEST BENGAL
9830108409
hilandsus@gmail.com
Dr Amitabh Dutta
Sir Ganga Ram Hospital
Senior Consultant & Professor
Department of Anaesthesiology
Pain & Perioperative Medicine, 5th Floor SSRB, Sir Ganga Ram
Hospital Old Rajinder Nagar 110060, Central, DELHI Central DELHI
Ethics Committee of GSVM medical college for Dr Agarwal
Approved
Ethics Committee Sir Ganga Ram Hospital
Approved
IEC of JSS Medical College & Hospital for Dr Gurudatt
Approved
Institutional Ethics Committee (IEC-CS), Apollo Hospitals (Apollo Health City) for Dr Reddy
Approved
Institutional Ethics Committee for Dr Bhalerao
Approved
Institutional Ethics Committee Mysore medical college and Research Institute for Dr Shashikala
Approved
Institutional Ethics Committee of Indira Gandhi Institute of Medical Sciences (IGMS) for Dr Swati
Approved
Institutional Ethics Committee of Sparsh Hospital for Dr Hegde
Approved
Institutional Ethics Committee, Department of Pharmacology for Dr Naresh
Approved
IPGME and Research Oversight Committee Institute of Postgraduate Medical Education and Research for Dr Sarbari Swaika
Approved
MGM Ethics Committee for Research on Human Subjects (MGM-ECRHS) for Dr Vasanti
Approved
Peerless Hospitex Hospital and research center limited clinical research ethics committee
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: 3||Administration,
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
Ropivacaine Balloon Pump Infusor 2mg/ml
as a continuous surgical site infusion for the Treatment of Post-Surgical Pain in lower abdominal laparotomy
Intervention
Ropivacaine Readyfusor 2mg/ml
as a continuous surgical site infusion for the Treatment of Post-Surgical Pain in lower abdominal laparotomy
Inclusion Criteria
Age From
18.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
1. Participant or participant’s legally acceptable representative is willing and able to give informed consent
2. Subjects of either gender with age 18 to 65 years (both inclusive) scheduled for lower abdominal surgery
3. Patient scheduled to undergo lower abdominal laparotomy surgery with requirement of hospitalization for at least 3 days
4. The length of surgical site incision should be around 15±3cms
5. Able and willing to comply with all study requirements
6. Subject doesn’t suffer from any significant co-morbidity which in the opinion of the investigator renders the patient unfit for the study’ American Society of Anesthesiologists [ASA] I-II
ExclusionCriteria
Details
1. History of allergy to study related drug, which would preclude all the possible combinations, capable of providing usual care multimodal analgesia: other local anesthetics, morphine, oxycodone, fentanyl, paracetamol
2. Body weight < 50 kg or a body mass index ≥ 40 kg/m2
3. Clinically significant illness or surgery within 1 week prior to screening visit (including flu, flu like symptoms, diarrhea, vomiting, ongoing sepsis/bacterial infections)
4. Any skin lesion/abnormality at site of catheterization
5. Chronic pain, with or without long-term regular analgesic usage
6. History of substance abuse
7. Pregnant or breast-feeding females
8. Participants not able to discontinue the prohibited medications listed in the protocol within the allotted time before surgery and throughout their duration of participation in the study
• Monoamine oxidase inhibitors within the past 30 days
• Anticonvulsants, tricyclic antidepressants (TCAs), neuroleptics, serotonin-norepinephrine reuptake inhibitors (SNRIs), as well as selective serotonin reuptake inhibitors (SSRIs; unless SSRIs have been prescribed for depression and/or anxiety and patients have been on a stable dose for at least 30 days prior to the screening visit)
• Corticosteroids: Oral and injectable corticosteroids must be discontinued 3 months prior to surgery; nasal, inhaled and topical corticosteroids will be allowed
9. Patients who have participated in any clinical trial within past 12 weeks
10. Chronic, high-dose opioid use (greater than 20 mg oxycodone-equivalent opioid use daily within the 2 weeks prior to surgery and duration of use > 4 weeks)
11. Concurrent painful physical conditions that may require analgesic treatment in the postsurgical period for pain that is not strictly related to the lower abdominal surgery of this study as pain from these conditions may confound postsurgical assessments
12. Any opioid medications, NSAIDs, or aspirin (except for low-dose aspirin used for cardioprotection) within 24 hours of study drug administration
13. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant’s ability to participate in the study
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Not Applicable
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
Proportion of patients achieving analgesic success measured through visual analogue score of ≤ 3 at 24 hours after the start of Ropivacaine infusion between both treatment arms
at 24 hours post-surgery
Secondary Outcome
Outcome
TimePoints
1 Pain intensity scores using visual analogue score (VAS; 0-10 mm) on 0, 6, 12, 24, 36 and 48 hours post-surgery
2 Difference in time required from unpacking the unit from its outer box to infusion of both therapies
3 Difference in number of doses of rescue medication consumed over 48 hrs of infusion period
4 Subject satisfaction with postsurgical pain control at 48 hours using a 5-point Likert scale
6 Investigator’s satisfaction for analgesic therapy using a 5-point Likert scale
0, 6, 12, 24, 36 and 48 hours post-surgery
Target Sample Size
Total Sample Size="156" Sample Size from India="156" Final Enrollment numbers achieved (Total)= "155" Final Enrollment numbers achieved (India)="155"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Brief Summary
This is A Randomized, Open-label, Prospective, Comparative, Multi-centre, Parallel group, Active controlled, Phase III Study to Evaluate the Efficacy and Safety of the Ropivacaine Readyfusor 2mg/ml versus Ropivacaine Balloon Pump Infusor 2mg/ml as a continuous surgical site infusion for the Treatment of Post-Surgical Pain in lower abdominal laparotomy. Total 156 human subjects planned for open laparotomy surgeries will be enrolled into the study (104 in investigational & 52 in active comparator arm). The study has 48 hours of study treatment duration.
The use of Ropivacaine Readyfusor 2mg/ml as a continuous infusion at surgical site and for peripheral nerve block is well established in European countries as well as Australia. As discussed with DCGI, the safety and efficacy of Ropivacaine as a drug is well-established in India. This study, however, is designed for a comparative clinical trial with balloon pump infusor in Indian population.