Study of Peri-Articular Anaesthetic for Replacement of the Knee

Knee Osteoarthritis Clinical Trial

— SPAARK  

Official title:

Study of Peri-Articular Anaesthetic for Replacement of the Knee

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03326180
• Other study ID #: OR16/88494
• Secondary ID: 2016-003154-3219
• Status: Completed
• Phase: Phase 3
• Start date: March 29, 2018
• Est. completion date: April 21, 2021

Study information

• Verified date: November 2022
• Source: University of Leeds
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 533
• Est. completion date: April 21, 2021
• Est. primary completion date: February 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• 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)

Locations

Country	Name	City	State
United Kingdom	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

Sponsors (2)

Lead Sponsor	Collaborator
University of Leeds	University of Oxford

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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: Physical comfort (12 items); Emotional state (9 items); Physical independence (5 items); Psychological support (7 items); 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
Primary	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	Mean 0-10 pain Visual Analogue Score (VAS)	Mean daily pain score at rest.; A 10 point scale where 0 = no pain, 5 = moderate pain and 10 = worst possible pain.	0, 24, 48 and 72 hours post-operatively
Secondary	Opioid consumption	Cumulative consumption	Change in consumption between 0, 24, 48 and 72 hours post-operatively
Secondary	Fitness for discharge (as per routine clinical care)	Against pre-defined criteria. Patients would be considered fit for discharge when they meet the following criteria: Ability to mobilize independently; pain score less than or equal to 3mm on a 10 VAS; ability to straight leg raise and ability to bend knee to 90 degrees	Assessed at 0, 24, 48 and 72 hours post-operatively
Secondary	Oxford Knee Score (OKS)	Functional outcome using validated, patient reported questionnaire	Change in score between baseline, 72 hours, 6 weeks, 6 months, 1 year post-operatively
Secondary	American Knee Society Score (AKSS)	Functional outcome using validated, patient reported questionnaire	Change in score between baseline, 72 hours, 6 weeks, 6 months, 1 year post-operatively
Secondary	EuroQol 5 Dimension scale	Validated patient reported quality of life questionnaire	Change in score between baseline, 72 hours, 6 weeks, 6 months, 1 year post-operatively
Secondary	Health economics	Cost utility analysis	Change in cost utility between baseline, 6 weeks, 6 months, 1 year post-operatively
Secondary	Serious Adverse Events (SAE)	Specifically cardiovascular or wound complications	Within 30 days of surgery

External Links

•   SPAARK website