Readyfusor health economics study
Research type
Research Study
Full title
Pilot healthcare economics and observational study of the OneDose ReadyfusOR (a factory-filled infusion device delivering a continuous infusion of ropivacaine 2mg/ml for up to 48 hours), for the treatment of post-operative pain in patients who have undergone open intra-abdominal surgery (laparotomy).
IRAS ID
223555
Contact name
Joshua Kriesel
Contact email
Sponsor organisation
BioQ Pharma Ltd.
Clinicaltrials.gov Identifier
ATC_047, The London Clinic, ATC reference
Duration of Study in the UK
1 years, 6 months, 0 days
Research summary
Technique was first described with the development of multi-holed catheters. Together with the widespread availability of infusion pumps, placement of multi-holed flexible catheters inside or alongside surgical wounds enables continuous, evenly spread infiltration of LA over an indefinite period. Among its advantages are a minimal failure rate and ease of placement with almost no insertion related complications, compared with neuraxial and peripheral nerve techniques. It offers the potential to reduce postoperative opioid requirements and their side-effects and increase postoperative patient mobility. A growing body of evidence supports the use and further study of continuous local anaesthetic wound infusion.2-5
OneDose ReadyfusOR system (RF)Continuous wound infusion of local anesthetics represents an effective analgesic technique that, because of its simplicity and improved safety may represent an advance across several major surgical procedures. To date, the widespread uptake of the technique of continuous perineural infusion of local anesthetics is hampered by the currently available technology: electronic pumps or elastomeric balloon pumps. Both options require set-up, but filling the latter is a particularly time-consuming process in the operating theatre. The disposable, single-use, RF system comprising a spring-compressed bag, factory-filled with ropivacaine (2mg/ml), addresses the issues of time-consuming and error/infection prone set-up and variable flow rates. Ropivacaine has been shown to have the lowest toxicity of the available local anaesthetic agents. RF is CE marked and has been granted marketing authorisation in Germany. In the UK, the application for marketing authorisation is under consideration, and hence the RF ropivacaine infusor will be assigned as treatment solely on clinical grounds, and made available through the special access program process, (MHRA Guidance Note 14) on the basis that the RF represents an advance in the application and safety of a proven technique in an area of unmet need and why this Readyfusor health economics study is needed.REC name
London - City & East Research Ethics Committee
REC reference
17/LO/0572
Date of REC Opinion
24 Apr 2017
REC opinion
Favourable Opinion