hip and knee osteoarthritis
Conditions
Interventions
Trade Name: Bupivacaine and Adrenaline injection B.P. 0.25% w/v 1 in 200,000
Product Name: Bupivicaine and Adrenaline Injection B.P. 0.25% w/v 1 in 200,000
Pharmaceutic
Sponsors
North Bristol NHS Trust, Research and Development
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients undergoing primary total hip replacement or primary total knee replacement for osteoarthritis at the Avon Orthopaedic Centre who are willing and able to provide fully-informed consent and complete the study questionnaires. 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: Patients undergoing revision joint replacement Patients undergoing joint replacement for a diagnosis other than osteoarthritis Patients under the age of 18 years. Patients with any medical co-morbidity that precludes spinal anaesthetic, regional blocks or the use of strong analgesics post-operatively. Diagnosis of severe dementia or psychiatric illness such that they are unable to complete the questionnaires or provide informed consent Patients undergoing stimulatenous bilateral joint replacement Patients who have been in the trial for a previous joint replacement Patients who are unable to understand English will be exclude because not all the validated questionnaires have been translated into languages other than English.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine if an injection of local anaesthetic directly into the operation site during total hip or total knee replacement, in addition to the standard anaesthetic regimen, can significantly reduce self-reported joint pain at 1-year after surgery compared to standard anaesthetic alone.;Secondary Objective: To determine, through the pilot study, whether the administration of resource use diaries aids participants in their completion of questionnaires. To explore the acceptability and feasibility of participation in the trial and the intervention through qualitative interviews with patients and healthcare professionals. To determine if the intervention reduces the incidence of central pain sensitisation after surgery using pressure Algometry (quantitative sensory testing) to measure pressure pain thresholds. To determine if the intervention is cost-effective by undertaking an analysis of health resource use.;Primary end point(s): The WOMAC pain score at 12-months post-operative. | — |
Countries
United Kingdom
Outcome results
None listed