Status:
COMPLETED
Study of Peri-Articular Anaesthetic for Replacement of the Knee
Lead Sponsor:
University of Leeds
Collaborating Sponsors:
University of Oxford
Conditions:
Knee Osteoarthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 replacem...
Detailed Description
The trial design is a patient-blinded multi-centre, active comparator, randomised controlled two-arm parallel group superiority trial of liposomal bupivacaine plus bupivacaine hydrochloride versus bup...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
March 29 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 21 2021
Estimated Enrollment :
533 Patients enrolled
Trial Details
Trial ID
NCT03326180
Start Date
March 29 2018
End Date
April 21 2021
Last Update
November 4 2022
Active Locations (11)
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1
The Royal Orthopaedic Hospital
Birmingham, United Kingdom
2
Chapel Allerton Hospital
Leeds, United Kingdom
3
Pilgrim Hospital, United Lincolnshire Hospitals NHS Trust
Lincoln, United Kingdom
4
The Whittington Hospital
London, United Kingdom