Local anaesthetic for patients undergoing knee replacement surgery for arthritis
Conditions
Interventions
Trade Name: EXPAREL
Product Name: EXPAREL
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Liposomal Bupivacaine
CAS Number: 38396-39-3
Concentration unit: mg milligram(s)
Concentrat
Sponsors
University of Leeds
Eligibility
Sex/Gender
All
Inclusion criteria
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. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 250 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 250
Exclusion criteria
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 result 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 (If the patient is receiving staged bilateral knees, they may still participate in the trial but data will only be included from the first knee)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To see how well a new local anaesthetic (pain killer), liposomal bupivacaine, works when compared to a standard pain killer, bupivacaine hydrochloride, that is routinely injected at the time of knee replacement surgery. ;Secondary Objective: To assess other aspects of patient recovery both in short and long term recovery using a range of patient-reported and objective outcome measures. To evaluate the cost effectiveness of liposomal bupivacaine compared with the current standard of care. ;Primary end point(s): Quality of Recovery 40 Score at 72 hours. Cumulative daily pain score at rest using VAS 0 to 72 hours. ;Timepoint(s) of evaluation of this end point: 72 hours following surgery (known as day 0, 1, 2 and 3) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To assess other markers of recovery both in the short term and long term: - Mean pain score measured using a 0-10 VAS at: baseline and evening of surgery day 0, 1, 2 and 3 following surgery. - Quality of Recovery 40 Score at baseline and evening of surgery day 0, 1, 2 and 3 following surgery. - Cumulative opioid consumption over 72 hours. Fitness for discharge against pre-defined criteria at: evening of surgery day 0, 1, 2 and 3 following surgery. - Functional outcome at baseline, 6 weeks, 6 months and 1 year (Oxford Knee Score, American Knee Society Score) Cost utility analysis using patient-reported quality of life as the main outcome, obtained using the EuroQol EQ5D-5 Level questionnaire at baseline, 72 hours, 6 weeks, 6 months and 1 year. Serious adverse events up to 12 months post-randomisation. Related AEs up to 30 days post-surgery. Intraoperative and inpatient complications, specifically cardiovascular or wound complications. ;Timepoint(s) of evaluation of this end point: 72 hours following surgery; 6 weeks, 6 months & 1 year | — |
Countries
United Kingdom
Contacts
Public ContactLisa Poulton
University of Oxford
Outcome results
None listed