Liposomal bupivacaine in knee replacement surgery
Research type
Research Study
Full title
SPAARK: Study of Peri-Articular Anaesthetic for Replacement of the Knee. The clinical and cost effectiveness of peri-articular liposomal bupivacaine compared with bupivacaine hydrochloride alone for post-operative recovery after knee replacement surgery: A multi-centre, patient-blinded, randomised controlled trial.
IRAS ID
197936
Contact name
Ivy Raymundo
Contact email
Sponsor organisation
University of Leeds
Eudract number
2016-003154-32
Duration of Study in the UK
2 years, 11 months, 30 days
Research summary
Research Summary:
Around 100,000 primary knee replacements were performed in the United Kingdom (UK) last year. Despite development of guidelines to assist clinicians recognize and treat the so called ‘fifth vital sign’,pain, 40% of patients report severe pain following knee replacement. The treatment of acute post-operative pain remains an unmet health need. Pain management using multi-modal analgesia can reduce the surgical stress response and permits early rehabilitation.
Local anaesthetic infiltration at the surgical site is commonly used with the view that modification of pain at its origin will reduce pain and stress responses. Liposomal bupivacaine is a new sustained release formulation of local anaesthetic which has reported to be effective for much longer than traditional local anaesthetic (up to 72 hours). Patients treated with the drug in the United States, were reported to be able to go home on the day of surgery. It is not yet licensed in the UK or Europe, but the active component, bupivacaine hydrochloride, is licensed and widely used as a local anaesthetic. The same liposomal formulations, for other types of medication are licensed for use in the UK (Depocyt; liposomal cytarabine).
This patient-blinded randomised controlled trial aims to evaluate the effectiveness of liposomal bupivacaine versus standard bupivacaine on post-operative recovery for total knee replacement patients. The surgical team performing the operation will administer the drug via wound infiltration during surgery. Patients will be asked about their recovery throughout hospitalisation and at 6 weeks, 6 months and 1 year postoperatively.
Participants will be recruited from up to 10 centres across the UK performing knee replacement surgery.
This study is funded by a Research for Patient Benefit (RfPB) grant from the National Institute for Health Research (NIHR).Summary of Results:
We recruited 533 patients from 11 NHS hospitals. The results of the study showed that pain scores reported by patients, use of additional medications and complications were similar in both patient groups. We also found that costs and overall quality of life were very similar but favouring slightly the bupivacaine hydrochloride group. Hence, Exparel was found not to be good value for money (i.e., cost-effective) compared to bupivacaine hydrochloride.
REC name
South Central - Oxford C Research Ethics Committee
REC reference
17/SC/0139
Date of REC Opinion
8 Jun 2017
REC opinion
Further Information Favourable Opinion