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Study of Peri-Articular Anaesthetic for Replacement of the Knee (SPAARK)

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
Liposomal bupivacaine
Bupivacaine hydrochloride
Sponsored by
University of Leeds
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Royal Orthopaedic Hospital
  • Chapel Allerton Hospital
  • Pilgrim Hospital, United Lincolnshire Hospitals NHS Trust
  • The Whittington Hospital
  • Robert Jones and Agnes Hunt Orthopaedic Hospital
  • Rotherham Hospital
  • King's Mill Hospital, Sherwood Forest Hospitals NHS Foundation Trust
  • Torbay Hospital
  • Pinderfields Hospital - Mid Yorkshire
  • Yeovil District Hospital
  • York Teaching Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Liposomal bupivacaine (EXPAREL)

Bupivacaine hydrochloride alone

Arm Description

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.

100ml 0.9% normal saline mixed with 100mg/20ml 0.5% plain bupivacaine hydrochloride. Administered as a single dose intra-operatively by periarticular infiltration.

Outcomes

Primary Outcome Measures

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).
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.

Secondary Outcome Measures

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.
Opioid consumption
Cumulative consumption
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
Oxford Knee Score (OKS)
Functional outcome using validated, patient reported questionnaire
American Knee Society Score (AKSS)
Functional outcome using validated, patient reported questionnaire
EuroQol 5 Dimension scale
Validated patient reported quality of life questionnaire
Health economics
Cost utility analysis
Serious Adverse Events (SAE)
Specifically cardiovascular or wound complications

Full Information

First Posted
October 11, 2017
Last Updated
November 3, 2022
Sponsor
University of Leeds
Collaborators
University of Oxford
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1. Study Identification

Unique Protocol Identification Number
NCT03326180
Brief Title
Study of Peri-Articular Anaesthetic for Replacement of the Knee
Acronym
SPAARK
Official Title
Study of Peri-Articular Anaesthetic for Replacement of the Knee
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
March 29, 2018 (Actual)
Primary Completion Date
February 28, 2021 (Actual)
Study Completion Date
April 21, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Leeds
Collaborators
University of Oxford

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
533 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Liposomal bupivacaine (EXPAREL)
Arm Type
Experimental
Arm Description
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.
Arm Title
Bupivacaine hydrochloride alone
Arm Type
Active Comparator
Arm Description
100ml 0.9% normal saline mixed with 100mg/20ml 0.5% plain bupivacaine hydrochloride. Administered as a single dose intra-operatively by periarticular infiltration.
Intervention Type
Drug
Intervention Name(s)
Liposomal bupivacaine
Other Intervention Name(s)
EXPAREL
Intervention Description
266mg/20ml vial of EXPAREL
Intervention Type
Drug
Intervention Name(s)
Bupivacaine hydrochloride
Other Intervention Name(s)
Marcain
Intervention Description
100mg/20ml 0.5% bupivacaine hydrochloride. Branded or generic, must be plain (cannot contain adrenaline/epinephrine)
Primary Outcome Measure Information:
Title
Quality of Recovery 40 (QoR-40)
Description
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).
Time Frame
Change in score between 0, 24, 48 and 72 hours post-operatively
Title
Cumulative 0-10 pain Visual Analogue Score (VAS)
Description
Cumulative daily pain score at rest. A 10 point scale where 0 = no pain, 5 = moderate pain and 10 = worst possible pain.
Time Frame
Cumulative score at 0, 24, 48 and 72 hours post-operatively
Secondary Outcome Measure Information:
Title
Mean 0-10 pain Visual Analogue Score (VAS)
Description
Mean daily pain score at rest. A 10 point scale where 0 = no pain, 5 = moderate pain and 10 = worst possible pain.
Time Frame
0, 24, 48 and 72 hours post-operatively
Title
Opioid consumption
Description
Cumulative consumption
Time Frame
Change in consumption between 0, 24, 48 and 72 hours post-operatively
Title
Fitness for discharge (as per routine clinical care)
Description
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
Time Frame
Assessed at 0, 24, 48 and 72 hours post-operatively
Title
Oxford Knee Score (OKS)
Description
Functional outcome using validated, patient reported questionnaire
Time Frame
Change in score between baseline, 72 hours, 6 weeks, 6 months, 1 year post-operatively
Title
American Knee Society Score (AKSS)
Description
Functional outcome using validated, patient reported questionnaire
Time Frame
Change in score between baseline, 72 hours, 6 weeks, 6 months, 1 year post-operatively
Title
EuroQol 5 Dimension scale
Description
Validated patient reported quality of life questionnaire
Time Frame
Change in score between baseline, 72 hours, 6 weeks, 6 months, 1 year post-operatively
Title
Health economics
Description
Cost utility analysis
Time Frame
Change in cost utility between baseline, 6 weeks, 6 months, 1 year post-operatively
Title
Serious Adverse Events (SAE)
Description
Specifically cardiovascular or wound complications
Time Frame
Within 30 days of surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hemant Pandit
Organizational Affiliation
University of Leeds
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Royal Orthopaedic Hospital
City
Birmingham
Country
United Kingdom
Facility Name
Chapel Allerton Hospital
City
Leeds
Country
United Kingdom
Facility Name
Pilgrim Hospital, United Lincolnshire Hospitals NHS Trust
City
Lincoln
Country
United Kingdom
Facility Name
The Whittington Hospital
City
London
Country
United Kingdom
Facility Name
Robert Jones and Agnes Hunt Orthopaedic Hospital
City
Oswestry
Country
United Kingdom
Facility Name
Rotherham Hospital
City
Rotherham
Country
United Kingdom
Facility Name
King's Mill Hospital, Sherwood Forest Hospitals NHS Foundation Trust
City
Sutton In Ashfield
Country
United Kingdom
Facility Name
Torbay Hospital
City
Torquay
Country
United Kingdom
Facility Name
Pinderfields Hospital - Mid Yorkshire
City
Wakefield
Country
United Kingdom
Facility Name
Yeovil District Hospital
City
Yeovil
Country
United Kingdom
Facility Name
York Teaching Hospital
City
York
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://spaark.octru.ox.ac.uk/
Description
SPAARK website

Learn more about this trial

Study of Peri-Articular Anaesthetic for Replacement of the Knee

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