Liposomal bupivacaine in knee replacement surgery

INTERVENTION: Patients with osteoarthritis of the knee that require a knee replacement operation are asked to take part in the study. During the clinic appointment, the surgeon tells the patient a little bit about the study and the local research nurses discuss the study and what it involves. This should take about 10 minutes. If the patient is interested in participating, they are assessed by one of the research team to answer some questions about their knee function and are asked to complete a questionnaire. The researcher also examines the knee. During the knee operation, as part of the routine operation, the surgeon injects local anaesthetic around the knee. If a patient consents to participate they are randomly assigned to receive either the current local anaesthetic injection (bupivacaine hydrochloride) or the new trial local anaesthetic injection (liposomal bupivacaine). Both injections are given using the same technique before the surgeon finishes the operation. After the operation, the patient will be cared for as per routine care at the hospital. For 3 days (72 hours) after the surgery, the participant are asked to complete a daily questionnaire so that the study team can find out how they are feeling after the surgery. Routine hospital follow‐up for this operation is at approximately six weeks and six months post‐surgery. The SPAARK assessments are scheduled at the same time so that the participants do not have to make an extra ‘research only’ visit to the hospital. Ahead of these appointments, the participants are sent a questionnaire to complete and return (either by post or email). A questionnaire is also sent one year after the operation. This should take about half an hour to complete. Allocation to either local anaesthetic is done randomly as this is the best way to allow a fair comparison to be made between the two treatments. This is the standard and only reliable way to see how good a treatment is. Whichever local anaesthetic is allocated, the patient wi CONDITION: Specialty: Musculoskeletal disorders, Primary sub‐specialty: Elective Orthopaedic Surgery; UKCRC code/ Disease: Musculoskeletal/ Other joint disorders ; Musculoskeletal Diseases ; Elective orthopaedic surgery PRIMARY OUTCOME: The effectiveness of liposomal bupivacaine with bupivacaine hydrochloride compared to bupivacaine hydrochloride alone on post‐operative recovery is assessed both in terms of systemic recovery as well as local recovery of the operated joint. This will be measured using the quality of recovery 40 Score at 72 hours and the cumulative daily pain score at rest using VAS 0 to 72 hours. INCLUSION CRITERIA: Current participant inclusion criteria as of 26/10/2018: 1. Unilateral primary knee replacement, including both total knee replacement (TKR) or unicompartmental knee replacement (UKR), for end stage osteoarthritis 2. Willing and able consent for themselves 3. Male or female, aged 18 years or above 4. In the Investigator’s opinion, is able and willing to comply with all trial requirements. Previous participant INCLUSION CRITERIA: 1. Participant is willing and able consent for themselves 2. Male or Female, aged 18 years or above 3. End stage osteoarthritis of the knee 4. In the Investigator’s opinion, is able and willing to comply with all trial requirements SECONDARY OUTCOME: 1. Other markers of recovery both in the short term and long term are measured using:; 1.1. Mean pain score measured using a 0‐10 VAS at: baseline and evening of surgery day 0, 1, 2 and 3 following surgery; 1.2. Quality of Recovery 40 Score at baseline and evening of surgery day 0, 1, 2 and 3 following surgery; 1.3. Cumulative opioid consumption over 72 hours.; 1.4. Fitness for discharge against pre‐defined criteria at evening of surgery day 0, 1, 2 and 3 following surgery; 1.5. Functional outcome at baseline, 6 weeks, 6 months and 1 year (Oxford Knee Score, American Knee Society Score); 2. Cost effectiveness of the intervention compared with the current standard of care is measured using cost utility analysis using patient‐reported quality of life as the main outcome, obtained using the EuroQol EQ‐5D‐5L questionnaire at baseline, 72 hours, 6 weeks, 6 months and 1 year; 3. Safety is measured using serious adverse events, specifically cardiovascular or wound complications within 30 days of surgery;