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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
533
266mg/20ml vial of EXPAREL
100mg/20ml 0.5% bupivacaine hydrochloride. Branded or generic, must be plain (cannot contain adrenaline/epinephrine)
The Royal Orthopaedic Hospital
Birmingham, United Kingdom
Chapel Allerton Hospital
Leeds, United Kingdom
Pilgrim Hospital, United Lincolnshire Hospitals NHS Trust
Lincoln, United Kingdom
Quality of Recovery 40 (QoR-40)
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).
Time frame: Change in score between 0, 24, 48 and 72 hours post-operatively
Cumulative 0-10 pain Visual Analogue Score (VAS)
Cumulative daily pain score at rest. A 10 point scale where 0 = no pain, 5 = moderate pain and 10 = worst possible pain.
Time frame: Cumulative score at 0, 24, 48 and 72 hours post-operatively
Mean 0-10 pain Visual Analogue Score (VAS)
Mean daily pain score at rest. A 10 point scale where 0 = no pain, 5 = moderate pain and 10 = worst possible pain.
Time frame: 0, 24, 48 and 72 hours post-operatively
Opioid consumption
Cumulative consumption
Time frame: Change in consumption between 0, 24, 48 and 72 hours post-operatively
Fitness for discharge (as per routine clinical care)
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
Time frame: Assessed at 0, 24, 48 and 72 hours post-operatively
Oxford Knee Score (OKS)
Functional outcome using validated, patient reported questionnaire
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The Whittington Hospital
London, United Kingdom
Robert Jones and Agnes Hunt Orthopaedic Hospital
Oswestry, United Kingdom
Rotherham Hospital
Rotherham, United Kingdom
King's Mill Hospital, Sherwood Forest Hospitals NHS Foundation Trust
Sutton in Ashfield, United Kingdom
Torbay Hospital
Torquay, United Kingdom
Pinderfields Hospital - Mid Yorkshire
Wakefield, United Kingdom
Yeovil District Hospital
Yeovil, United Kingdom
...and 1 more locations
Time frame: Change in score between baseline, 72 hours, 6 weeks, 6 months, 1 year post-operatively
American Knee Society Score (AKSS)
Functional outcome using validated, patient reported questionnaire
Time frame: Change in score between baseline, 72 hours, 6 weeks, 6 months, 1 year post-operatively
EuroQol 5 Dimension scale
Validated patient reported quality of life questionnaire
Time frame: Change in score between baseline, 72 hours, 6 weeks, 6 months, 1 year post-operatively
Health economics
Cost utility analysis
Time frame: Change in cost utility between baseline, 6 weeks, 6 months, 1 year post-operatively
Serious Adverse Events (SAE)
Specifically cardiovascular or wound complications
Time frame: Within 30 days of surgery