Knee Osteoarthritis
Conditions
Brief summary
The clinical and cost effectiveness of peri-articular liposomal bupivacaine plus bupivacaine hydrochloride compared with bupivacaine hydrochloride alone for post-operative recovery after knee replacement surgery: A multi-centre, patient-blinded, randomised controlled trial.
Detailed description
The trial design is a patient-blinded multi-centre, active comparator, randomised controlled two-arm parallel group superiority trial of liposomal bupivacaine plus bupivacaine hydrochloride versus bupivacaine alone for post-operative pain in patients undergoing knee replacement surgery. Patients will be randomised in a 1:1 ratio. The randomised controlled trial (RCT) design is robust and reduces any potential bias. Patients will be blinded as to which treatment they receive. Blinding of patients is possible as they will be under general anaesthetic for their knee replacement surgery at the time of the drug administration. Blinding of surgeons, who administer the medication and outcome assessors was not necessary as the primary outcome is a patient reported outcome measure.
Interventions
DRUGLiposomal bupivacaine
266mg/20ml vial of EXPAREL
DRUGBupivacaine hydrochloride
100mg/20ml 0.5% bupivacaine hydrochloride. Branded or generic, must be plain (cannot contain adrenaline/epinephrine)
Sponsors
University of Oxford
University of Leeds
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Unilateral primary knee replacement, including both total knee replacement (TKR) or unicompartmental knee replacement (UKR), for end stage osteoarthritis * American Society of Anaesthesiologists (ASA) Grade I to III * Participant is willing and able consent for themselves * Male or Female, aged 18 years or above * In the Investigator's opinion, is able and willing to comply with all trial requirements
Exclusion criteria
* Allergy or intolerance to amide type local anaesthetics * Objective evidence of nerve damage in the affected lower limb. * Rheumatoid arthritis * Any other significant disease, disorder or condition which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the results of the trial, or the participant's ability to participate in the trial. * Participants who have participated in another research trial involving an investigational product in the past 6 months. * Participants who have significant cognitive impairment or language issues * Contra-lateral knee replacement within the trial or within 12 months prior to randomisation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Recovery 40 (QoR-40) | Change in score between 0, 24, 48 and 72 hours post-operatively | A 40-item instrument which encompass most aspects of a good quality of recovery after surgery. Consists of five clinically relevant dimensions: 1. Physical comfort (12 items) 2. Emotional state (9 items) 3. Physical independence (5 items) 4. Psychological support (7 items) 5. Pain (7 items). The QoR-40 has a possible score of 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery). |
| Cumulative 0-10 pain Visual Analogue Score (VAS) | Cumulative score at 0, 24, 48 and 72 hours post-operatively | Cumulative daily pain score at rest. A 10 point scale where 0 = no pain, 5 = moderate pain and 10 = worst possible pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fitness for discharge (as per routine clinical care) | Assessed at 0, 24, 48 and 72 hours post-operatively | Against pre-defined criteria. Patients would be considered fit for discharge when they meet the following criteria: Ability to mobilize independently; pain score less than or equal to 3mm on a 10 VAS; ability to straight leg raise and ability to bend knee to 90 degrees |
| Oxford Knee Score (OKS) | Change in score between baseline, 72 hours, 6 weeks, 6 months, 1 year post-operatively | Functional outcome using validated, patient reported questionnaire |
| American Knee Society Score (AKSS) | Change in score between baseline, 72 hours, 6 weeks, 6 months, 1 year post-operatively | Functional outcome using validated, patient reported questionnaire |
| Mean 0-10 pain Visual Analogue Score (VAS) | 0, 24, 48 and 72 hours post-operatively | Mean daily pain score at rest. A 10 point scale where 0 = no pain, 5 = moderate pain and 10 = worst possible pain. |
| Health economics | Change in cost utility between baseline, 6 weeks, 6 months, 1 year post-operatively | Cost utility analysis |
| Serious Adverse Events (SAE) | Within 30 days of surgery | Specifically cardiovascular or wound complications |
| EuroQol 5 Dimension scale | Change in score between baseline, 72 hours, 6 weeks, 6 months, 1 year post-operatively | Validated patient reported quality of life questionnaire |
| Opioid consumption | Change in consumption between 0, 24, 48 and 72 hours post-operatively | Cumulative consumption |
Countries
United Kingdom
Outcome results
None listed