Clinical trial NCT03326180: Study of Peri-Articular Anaesthetic for Replacement of the Knee
Official title: Study of Peri-Articular Anaesthetic for Replacement of the Knee
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Knee Osteoarthritis
Lead sponsor: University of Leeds
Sponsor class: OTHER
Collaborators: name: University of Oxford
First posted: 2017-10-31
Enrollment: 533
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 bupivacaine alone for post-operative pain in patients undergoing knee replacement surgery.

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.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Quality of Recovery 40 (QoR-40)
timeFrame: Change in score between 0, 24, 48 and 72 hours post-operatively
measure: Cumulative 0-10 pain Visual Analogue Score (VAS)
timeFrame: Cumulative score at 0, 24, 48 and 72 hours post-operatively
Secondary outcomes:
measure: Mean 0-10 pain Visual Analogue Score (VAS)
timeFrame: 0, 24, 48 and 72 hours post-operatively
measure: Opioid consumption
timeFrame: Change in consumption between 0, 24, 48 and 72 hours post-operatively
measure: Fitness for discharge (as per routine clinical care)
timeFrame: Assessed at 0, 24, 48 and 72 hours post-operatively
measure: Oxford Knee Score (OKS)
timeFrame: Change in score between baseline, 72 hours, 6 weeks, 6 months, 1 year post-operatively
measure: American Knee Society Score (AKSS)
timeFrame: Change in score between baseline, 72 hours, 6 weeks, 6 months, 1 year post-operatively
measure: EuroQol 5 Dimension scale
timeFrame: Change in score between baseline, 72 hours, 6 weeks, 6 months, 1 year post-operatively
measure: Health economics
timeFrame: Change in cost utility between baseline, 6 weeks, 6 months, 1 year post-operatively
measure: Serious Adverse Events (SAE)
timeFrame: Within 30 days of surgery
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: The Royal Orthopaedic Hospital
city: Leeds
country: United Kingdom
facility: Chapel Allerton Hospital
city: Lincoln
country: United Kingdom
facility: Pilgrim Hospital, United Lincolnshire Hospitals NHS Trust
city: London
country: United Kingdom
facility: The Whittington Hospital
city: Oswestry
country: United Kingdom
facility: Robert Jones and Agnes Hunt Orthopaedic Hospital
city: Rotherham
country: United Kingdom
facility: Rotherham Hospital
city: Sutton In Ashfield
country: United Kingdom
facility: King's Mill Hospital, Sherwood Forest Hospitals NHS Foundation Trust
city: Torquay
country: United Kingdom
facility: Torbay Hospital
city: Wakefield
country: United Kingdom
facility: Pinderfields Hospital - Mid Yorkshire
city: Yeovil
country: United Kingdom
facility: Yeovil District Hospital
city: York
country: United Kingdom
facility: York Teaching Hospital
Study officials:
affiliation: University of Leeds
name: Hemant Pandit
role: PRINCIPAL_INVESTIGATOR
References: