Study of Peri-Articular Anaesthetic for Replacement of the Knee
- Conditions
- Knee Osteoarthritis
- Interventions
- Registration Number
- NCT03326180
- Lead Sponsor
- University of Leeds
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 533
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Liposomal bupivacaine (EXPAREL) Liposomal bupivacaine 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. Liposomal bupivacaine (EXPAREL) Bupivacaine hydrochloride 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. Bupivacaine hydrochloride alone 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.Opioid consumption Change in consumption between 0, 24, 48 and 72 hours post-operatively Cumulative consumption
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
Health economics Change in cost utility between baseline, 6 weeks, 6 months, 1 year post-operatively Cost utility analysis
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
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
Serious Adverse Events (SAE) Within 30 days of surgery Specifically cardiovascular or wound complications
Trial Locations
- Locations (11)
The Royal Orthopaedic Hospital
🇬🇧Birmingham, United Kingdom
The Whittington Hospital
🇬🇧London, United Kingdom
Chapel Allerton Hospital
🇬🇧Leeds, United Kingdom
Pilgrim Hospital, United Lincolnshire Hospitals NHS Trust
🇬🇧Lincoln, 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
York Teaching Hospital
🇬🇧York, United Kingdom