Study of Peri-Articular Anaesthetic for Replacement of the Knee
SPAARK
3 other identifiers
interventional
533
1 country
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 knee-osteoarthritis
Started Mar 2018
Typical duration for phase_3 knee-osteoarthritis
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 11, 2017
CompletedFirst Posted
Study publicly available on registry
October 31, 2017
CompletedStudy Start
First participant enrolled
March 29, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 21, 2021
CompletedNovember 4, 2022
November 1, 2022
2.9 years
October 11, 2017
November 3, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
Quality of Recovery 40 (QoR-40)
A 40-item instrument which encompass most aspects of a good quality of recovery after surgery. Consists of five clinically relevant dimensions: 1. Physical comfort (12 items) 2. Emotional state (9 items) 3. Physical independence (5 items) 4. Psychological support (7 items) 5. Pain (7 items). The QoR-40 has a possible score of 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery).
Change in score between 0, 24, 48 and 72 hours post-operatively
Cumulative 0-10 pain Visual Analogue Score (VAS)
Cumulative daily pain score at rest. A 10 point scale where 0 = no pain, 5 = moderate pain and 10 = worst possible pain.
Cumulative score at 0, 24, 48 and 72 hours post-operatively
Secondary Outcomes (8)
Mean 0-10 pain Visual Analogue Score (VAS)
0, 24, 48 and 72 hours post-operatively
Opioid consumption
Change in consumption between 0, 24, 48 and 72 hours post-operatively
Fitness for discharge (as per routine clinical care)
Assessed at 0, 24, 48 and 72 hours post-operatively
Oxford Knee Score (OKS)
Change in score between baseline, 72 hours, 6 weeks, 6 months, 1 year post-operatively
American Knee Society Score (AKSS)
Change in score between baseline, 72 hours, 6 weeks, 6 months, 1 year post-operatively
- +3 more secondary outcomes
Study Arms (2)
Liposomal bupivacaine (EXPAREL)
EXPERIMENTAL266mg/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.
Bupivacaine hydrochloride alone
ACTIVE COMPARATOR100ml 0.9% normal saline mixed with 100mg/20ml 0.5% plain bupivacaine hydrochloride. Administered as a single dose intra-operatively by periarticular infiltration.
Interventions
266mg/20ml vial of EXPAREL
100mg/20ml 0.5% bupivacaine hydrochloride. Branded or generic, must be plain (cannot contain adrenaline/epinephrine)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Leedslead
- University of Oxfordcollaborator
Study Sites (11)
The Royal Orthopaedic Hospital
Birmingham, United Kingdom
Chapel Allerton Hospital
Leeds, United Kingdom
Pilgrim Hospital, United Lincolnshire Hospitals NHS Trust
Lincoln, United Kingdom
The Whittington Hospital
London, United Kingdom
Robert Jones and Agnes Hunt Orthopaedic Hospital
Oswestry, United Kingdom
Rotherham Hospital
Rotherham, United Kingdom
King's Mill Hospital, Sherwood Forest Hospitals NHS Foundation Trust
Sutton in Ashfield, United Kingdom
Torbay Hospital
Torquay, United Kingdom
Pinderfields Hospital - Mid Yorkshire
Wakefield, United Kingdom
Yeovil District Hospital
Yeovil, United Kingdom
York Teaching Hospital
York, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hemant Pandit
University of Leeds
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 11, 2017
First Posted
October 31, 2017
Study Start
March 29, 2018
Primary Completion
February 28, 2021
Study Completion
April 21, 2021
Last Updated
November 4, 2022
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will not share