Osteoarthritis- those patients requiring total knee arthroplasty
Conditions
Interventions
Product Name: Ketorolac Trometamol
Product Code: PAMMIX
Pharmaceutical Form: Powder for injection*
INN or Proposed INN: ketorolac trometamol
CAS Number: 74103-07-4
Current Sponsor code: ketorolac
Conc
Sponsors
University of Warwick
University Hospitals Coventry & Warwickshire NHS trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All patients undergoing an elective primary unilateral total knee arthroplasty under the care of an orthopaedic consultant at University Hospitals Coventry and Warwickshire NHS trust will be eligible for the trial unless they fit the exclusion criteria. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: The following patients will not be eligible for entry to the trial: Those with sufficient cognitive impairment that they would be unable complete questionnaire (cognitive impairment). Those patients who lack capacity under the Mental Capacity Act 2005 Those patients with a pre-operative history of neurological abnormality in the ipsilateral leg e.g. history of stroke, neurogenic pain or previous nerve injury. Those patients having spinal anaesthesia. Those patients with a specific contraindication to the analgesic agents used: Morphine: ? Hypersensitivity reaction Ketorolac: ? Active or previous peptic ulcer. History of upper gastrointestinal bleeding or perforation, related to previous NSAID therapy. ? Haemorrhagic diatheses, including coagulation disorders ? Hypersensitivity to ketorolac trometamol or other NSAIDs ? Moderate or severe renal impairment (serum creatinine > 160 micromol/l) Levobupivicaine: ? Levobupivacaine solutions are contra-indicated in patients with a known hypersensitivity to levobupivacaine, local anaesthetics of the amide type or any of the excipients ? Uncontrolled angina ? 2nd/ 3rd degree heart block
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of this pilot study is to determine the effect of multi-modal, peri-articular knee infiltration upon pain relief following primary total knee arthroplasty surgery. ;Secondary Objective: We aim to establish the concentration of local anaesthetic in the blood and in the fluid collected in the knee re-transfusion drain after the surgery. We also are interested in the functional outcomes in patients that have had the techniques under investigations.;Primary end point(s): A validated, patient-reported 100 point visual analogue pain score at 6, 18 and 48 hours post operatively. | — |
Countries
United Kingdom
Outcome results
None listed