A Phase 3 interventional study of Liposomal bupivacaine and Bupivacaine hydrochloride in Knee Osteoarthritis, sponsored by University of Leeds. Completed at 11 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-04.
Sponsored by University of Leeds · Phase 3, Interventional, and Treatment
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.
3,292 studies on the registry are indexed under Osteoarthritis, Knee; 623 are open to participants now.
This study's enrollment of 533 is above the median of 68 across 2,714 interventional studies indexed under Osteoarthritis, Knee.
Browse Osteoarthritis, Knee studies →University of Leeds is the lead sponsor of 206 studies on the registry; 25 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
266mg/20ml EXPAREL mixed with 80ml 0.9% normal saline and 100mg/20ml 0.5% plain bupivacaine hydrochloride. Administered as a single dose intra-operatively by periarticular infiltration.
Drug: Liposomal bupivacaine · Drug: Bupivacaine hydrochloride
100ml 0.9% normal saline mixed with 100mg/20ml 0.5% plain bupivacaine hydrochloride. Administered as a single dose intra-operatively by periarticular infiltration.
Drug: Bupivacaine hydrochloride
266mg/20ml vial of EXPAREL
Also known as: EXPAREL
100mg/20ml 0.5% bupivacaine hydrochloride. Branded or generic, must be plain (cannot contain adrenaline/epinephrine)
Also known as: Marcain
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
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
Plan to share: No
This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Liposomal Bupivacaine