Study of Peri-Articular Anaesthetic for Replacement of the Knee
NCT ID: NCT03326180
Last Updated: 2022-11-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
533 participants
INTERVENTIONAL
2018-03-29
2021-04-21
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Liposomal bupivacaine (EXPAREL)
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.
Liposomal bupivacaine
266mg/20ml vial of EXPAREL
Bupivacaine hydrochloride
100mg/20ml 0.5% bupivacaine hydrochloride. Branded or generic, must be plain (cannot contain adrenaline/epinephrine)
Bupivacaine hydrochloride alone
100ml 0.9% normal saline mixed with 100mg/20ml 0.5% plain bupivacaine hydrochloride.
Administered as a single dose intra-operatively by periarticular infiltration.
Bupivacaine hydrochloride
100mg/20ml 0.5% bupivacaine hydrochloride. Branded or generic, must be plain (cannot contain adrenaline/epinephrine)
Interventions
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Liposomal bupivacaine
266mg/20ml vial of EXPAREL
Bupivacaine hydrochloride
100mg/20ml 0.5% bupivacaine hydrochloride. Branded or generic, must be plain (cannot contain adrenaline/epinephrine)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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University of Oxford
OTHER
University of Leeds
OTHER
Responsible Party
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Hemant Pandit
Professor
Principal Investigators
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Hemant Pandit
Role: PRINCIPAL_INVESTIGATOR
University of Leeds
Locations
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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
Countries
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Other Identifiers
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2016-003154-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
197936
Identifier Type: OTHER
Identifier Source: secondary_id
OR16/88494
Identifier Type: -
Identifier Source: org_study_id
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