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BACKGROUND: Optimising the management of peri-operative pain and recovery following knee replacement has been identified as a patient priority. Current pain relief strategies use opiate-based analgesia; however, up to 50% of patients experience significant side effects. Local anaesthetic incisional infiltration is one alternative. The length of the duration of action is a major limiting factor of current local anaesthetic techniques. Liposomal bupivacaine has been reported to be effective for up to 72 h. This randomised controlled trial will evaluate the clinical and cost effectiveness of liposomal bupivacaine. METHODS: SPAARK is a patient-blinded, multi-centre, active comparator, superiority, two-arm, parallel-group randomised controlled trial. Five hundred patients undergoing knee replacement will be recruited and randomised to liposomal bupivacaine plus bupivacaine hydrochloride or bupivacaine hydrochloride alone. The co-primary outcomes are the Quality of Recovery 40 measured at 72 h post-surgery and also cumulative pain measured daily using a 0-10 visual analogue scale for the first 3 days following surgery. Secondary outcomes include cumulative opioid consumption, fitness for discharge, functional outcomes assessed using the Oxford Knee Score and American Knee Society Score, the EuroQol five dimensions instrument and complications. A cost utility analysis is also planned. DISCUSSION: The clinical effectiveness and cost effectiveness of liposomal bupivacaine have yet to be evaluated in the National Health Service, making this trial appropriate and timely. TRIAL REGISTRATION: ISRCTN registry, ISRCTN54191675. Registered on 14 November 2017.

Original publication

DOI

10.1186/s13063-019-3826-1

Type

Journal article

Journal

Trials

Publication Date

16/12/2019

Volume

20

Keywords

Anaesthetic, Analgesia, Knee replacement, Liposomal bupivacaine, Peri-operative pain, Randomised controlled trial, Anesthetics, Local, Arthroplasty, Replacement, Knee, Bupivacaine, Cost-Benefit Analysis, Drug Costs, Equivalence Trials as Topic, Humans, Liposomes, Multicenter Studies as Topic, Osteoarthritis, Knee, Pain, Postoperative, Single-Blind Method, Time Factors, Treatment Outcome, United Kingdom