Study of Peri-Articular Anaesthetic for Replacement of the Knee (SPAARK)

University of Leeds

Status and phase: Completed; Phase 3

Conditions: Knee Osteoarthritis

Treatments: Drug: Liposomal bupivacaine; Drug: Bupivacaine hydrochloride

Study type: Interventional

Funder types: Other

Identifiers

NCT03326180

2016-003154-32 (EudraCT Number)

OR16/88494

197936 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 533 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.
• Participants who have significant cognitive impairment or language issues
• Contra-lateral knee replacement within the trial or within 12 months prior to randomisation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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533 participants in 2 patient groups

Liposomal bupivacaine (EXPAREL)

Experimental group

Description:

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.

Treatment:

Drug: Bupivacaine hydrochloride

Drug: Liposomal bupivacaine

Bupivacaine hydrochloride alone

Active Comparator group

Description:

100ml 0.9% normal saline mixed with 100mg/20ml 0.5% plain bupivacaine hydrochloride. Administered as a single dose intra-operatively by periarticular infiltration.

Treatment:

Drug: Bupivacaine hydrochloride