SPAARK: Study of Peri-Articular Anaesthetic for Replacement of the Knee
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Liposomal bupivacaine (EXPAREL) 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
266mg/20ml vial of EXPAREL
Other Names:
Drug: Bupivacaine hydrochloride
100mg/20ml 0.5% bupivacaine hydrochloride. Branded or generic, must be plain (cannot contain adrenaline/epinephrine)
Other Names:
|
| Active Comparator: Bupivacaine hydrochloride alone 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
100mg/20ml 0.5% bupivacaine hydrochloride. Branded or generic, must be plain (cannot contain adrenaline/epinephrine)
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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: Physical comfort (12 items) Emotional state (9 items) Physical independence (5 items) Psychological support (7 items) 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
- 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
- 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
- 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
- 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
Eligibility Criteria
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
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.
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Participants who have significant cognitive impairment or language issues
-
Contra-lateral knee replacement within the trial or within 12 months prior to randomisation
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The Royal Orthopaedic Hospital | Birmingham | United Kingdom | ||
| 2 | Chapel Allerton Hospital | Leeds | United Kingdom | ||
| 3 | Pilgrim Hospital, United Lincolnshire Hospitals NHS Trust | Lincoln | United Kingdom | ||
| 4 | The Whittington Hospital | London | United Kingdom | ||
| 5 | Robert Jones and Agnes Hunt Orthopaedic Hospital | Oswestry | United Kingdom | ||
| 6 | Rotherham Hospital | Rotherham | United Kingdom | ||
| 7 | King's Mill Hospital, Sherwood Forest Hospitals NHS Foundation Trust | Sutton In Ashfield | United Kingdom | ||
| 8 | Torbay Hospital | Torquay | United Kingdom | ||
| 9 | Pinderfields Hospital - Mid Yorkshire | Wakefield | United Kingdom | ||
| 10 | Yeovil District Hospital | Yeovil | United Kingdom | ||
| 11 | York Teaching Hospital | York | United Kingdom |
Sponsors and Collaborators
- University of Leeds
- University of Oxford
Investigators
- Principal Investigator: Hemant Pandit, University of Leeds
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- OR16/88494
- 2016-003154-32
- 197936