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.
- Conditions
- Administration,
- Registration Number
- CTRI/2019/09/021200
- Lead Sponsor
- Cipla Ltd
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 156
- 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.
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method 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
Trial Locations
- Locations (12)
Apollo Hospitals
🇮🇳Hyderabad, TELANGANA, India
B J Medical College and Sassoon General Hospital
🇮🇳Pune, MAHARASHTRA, India
Government Medical College and Hospital Nagpur
🇮🇳Nagpur, MAHARASHTRA, India
GSVM Medical college
🇮🇳Nagar, UTTAR PRADESH, India
Indira Gandhi Institute of Medical Science
🇮🇳Patna, BIHAR, India
Institute of Post Graduate Medical Education and Research SSKM Hospital
🇮🇳Kolkata, WEST BENGAL, India
JSS Hospital
🇮🇳Mysore, KARNATAKA, India
K.R Hospital, Mysore Medical College & Research Institute Mysore
🇮🇳Mysore, KARNATAKA, India
Mahatma Gandhi Mission’s Medical College & Hospital
🇮🇳Aurangabad, MAHARASHTRA, India
Peerless Hospitex Hospital and research center Ltd
🇮🇳Kolkata, WEST BENGAL, India
Scroll for more (2 remaining)Apollo Hospitals🇮🇳Hyderabad, TELANGANA, IndiaDr Gurrala Shekar ReddyPrincipal investigator9701002787drshekhargreddy@gmail.com