Study of Peri-Articular Anaesthetic for Replacement of the Knee (SPAARK): study protocol for a patient-blinded, randomised controlled superiority trial of liposomal bupivacaine
Ruth Knight,
Lisa Poulton,
Louise H. Strickland,
Thomas W. Hamilton,
David Beard,
Jonathan Cook,
Susan J. Dutton,
Jose Leal,
Sarah Lamb,
Cushla Cooper,
Karen L. Barker,
David W. Murray,
Hemant G. Pandit
Affiliations
Ruth Knight
Oxford Clinical Trials Research Unit, Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford
Lisa Poulton
Surgical Interventional Trials Unit, Nuffield Department Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford
Louise H. Strickland
Oxford Orthopaedic Engineering Centre, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford
Thomas W. Hamilton
Oxford Orthopaedic Engineering Centre, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford
David Beard
Surgical Interventional Trials Unit, Nuffield Department Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford
Jonathan Cook
Oxford Clinical Trials Research Unit, Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford
Susan J. Dutton
Oxford Clinical Trials Research Unit, Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford
Jose Leal
Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford
Sarah Lamb
Oxford Clinical Trials Research Unit, Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford
Cushla Cooper
Surgical Interventional Trials Unit, Nuffield Department Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford
Karen L. Barker
National Institute for Health Research Biomedical Research Unit, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford
David W. Murray
Oxford Orthopaedic Engineering Centre, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford
Hemant G. Pandit
Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds
Abstract 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.
