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

November 3, 2022 updated by: Hemant Pandit, University of Leeds
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
533

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Birmingham, United Kingdom
        • The Royal Orthopaedic Hospital
      • Leeds, United Kingdom
        • Chapel Allerton Hospital
      • Lincoln, United Kingdom
        • Pilgrim Hospital, United Lincolnshire Hospitals NHS Trust
      • London, United Kingdom
        • The Whittington Hospital
      • Oswestry, United Kingdom
        • Robert Jones and Agnes Hunt Orthopaedic hospital
      • Rotherham, United Kingdom
        • Rotherham Hospital
      • Sutton In Ashfield, United Kingdom
        • King's Mill Hospital, Sherwood Forest Hospitals NHS Foundation Trust
      • Torquay, United Kingdom
        • Torbay Hospital
      • Wakefield, United Kingdom
        • Pinderfields Hospital - Mid Yorkshire
      • Yeovil, United Kingdom
        • Yeovil District Hospital
      • York, United Kingdom
        • York Teaching Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: 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.
Drug: Liposomal bupivacaine
266mg/20ml vial of EXPAREL
Other Names:
  • EXPAREL
Drug: Bupivacaine hydrochloride
100mg/20ml 0.5% bupivacaine hydrochloride. Branded or generic, must be plain (cannot contain adrenaline/epinephrine)
Other Names:
  • Marcain
ACTIVE_COMPARATOR: 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.
Drug: Bupivacaine hydrochloride
100mg/20ml 0.5% bupivacaine hydrochloride. Branded or generic, must be plain (cannot contain adrenaline/epinephrine)
Other Names:
  • Marcain

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Quality of Recovery 40 (QoR-40)
Time Frame: Change in score between 0, 24, 48 and 72 hours post-operatively

A 40-item instrument which encompass most aspects of a good quality of recovery after surgery. Consists of five clinically relevant dimensions:

  1. Physical comfort (12 items)
  2. Emotional state (9 items)
  3. Physical independence (5 items)
  4. Psychological support (7 items)
  5. 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
Cumulative 0-10 pain Visual Analogue Score (VAS)
Time Frame: Cumulative score at 0, 24, 48 and 72 hours post-operatively

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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean 0-10 pain Visual Analogue Score (VAS)
Time Frame: 0, 24, 48 and 72 hours post-operatively

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
Opioid consumption
Time Frame: Change in consumption between 0, 24, 48 and 72 hours post-operatively
Cumulative consumption
Change in consumption between 0, 24, 48 and 72 hours post-operatively
Fitness for discharge (as per routine clinical care)
Time Frame: Assessed at 0, 24, 48 and 72 hours post-operatively
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
Oxford Knee Score (OKS)
Time Frame: Change in score between baseline, 72 hours, 6 weeks, 6 months, 1 year post-operatively
Functional outcome using validated, patient reported questionnaire
Change in score between baseline, 72 hours, 6 weeks, 6 months, 1 year post-operatively
American Knee Society Score (AKSS)
Time Frame: Change in score between baseline, 72 hours, 6 weeks, 6 months, 1 year post-operatively
Functional outcome using validated, patient reported questionnaire
Change in score between baseline, 72 hours, 6 weeks, 6 months, 1 year post-operatively
EuroQol 5 Dimension scale
Time Frame: Change in score between baseline, 72 hours, 6 weeks, 6 months, 1 year post-operatively
Validated patient reported quality of life questionnaire
Change in score between baseline, 72 hours, 6 weeks, 6 months, 1 year post-operatively
Health economics
Time Frame: Change in cost utility between baseline, 6 weeks, 6 months, 1 year post-operatively
Cost utility analysis
Change in cost utility between baseline, 6 weeks, 6 months, 1 year post-operatively
Serious Adverse Events (SAE)
Time Frame: Within 30 days of surgery
Specifically cardiovascular or wound complications
Within 30 days of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Leeds

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Oxford

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Hemant Pandit, University of Leeds

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 29, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 21, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 11, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 25, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 31, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 4, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • OR16/88494
  • 2016-003154-32 (EUDRACT_NUMBER)
  • 197936 (OTHER: Integrated Research Application System (IRAS))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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