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

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ClinicalTrials.gov Identifier: NCT03326180
Recruitment Status : Recruiting
First Posted : October 31, 2017
Last Update Posted : April 23, 2018
Sponsor:
Collaborator:
University of Oxford
Information provided by (Responsible Party):
Hemant Pandit, University of Leeds

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.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Drug: Liposomal bupivacaine Drug: Bupivacaine hydrochloride Phase 3

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Study of Peri-Articular Anaesthetic for Replacement of the Knee
Actual Study Start Date : March 29, 2018
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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 Name: EXPAREL

Drug: Bupivacaine hydrochloride
100mg/20ml 0.5% bupivacaine hydrochloride. Branded or generic, must be plain (cannot contain adrenaline/epinephrine)
Other Name: 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 Name: Marcain




Primary Outcome Measures :
  1. 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).


  2. 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.



Secondary Outcome Measures :
  1. 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.


  2. Opioid consumption [ Time Frame: Change in consumption between 0, 24, 48 and 72 hours post-operatively ]
    Cumulative consumption

  3. 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

  4. 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

  5. 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

  6. 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

  7. Health economics [ Time Frame: Change in cost utility between baseline, 6 weeks, 6 months, 1 year post-operatively ]
    Cost utility analysis

  8. Serious Adverse Events (SAE) [ Time Frame: Within 30 days of surgery ]
    Specifically cardiovascular or wound complications



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participant is willing and able consent for themselves
  • Male or Female, aged 18 years or above
  • End stage osteoarthritis of the knee
  • In the Investigator's opinion, is able and willing to comply with all trial requirements

Exclusion Criteria:

  • American Society of Anaesthesiologists (ASA) Grade III or above
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03326180


Contacts
Contact: Lisa Poulton +44(0)1865 223665 spaark@ndorms.ox.ac.uk

Locations
United Kingdom
Chapel Allerton Hospital Recruiting
Leeds, United Kingdom
Principal Investigator: Hemant Pandit, Prof         
Robert Jones and Agnes Hunt Orthopaedic Hospital Recruiting
Oswestry, United Kingdom
Principal Investigator: Anthony Smith, Mr         
Rotherham Hospital Recruiting
Rotherham, United Kingdom
Principal Investigator: Alex Anderson, Mr         
Pinderfields Hospital - Mid Yorkshire Recruiting
Wakefield, United Kingdom
Principal Investigator: Simon Jones, Mr         
Yeovil District Hospital Recruiting
Yeovil, United Kingdom
Principal Investigator: Ben Lankester, Mr         
Sponsors and Collaborators
University of Leeds
University of Oxford
Investigators
Principal Investigator: Hemant Pandit University of Leeds

Additional Information:
Responsible Party: Hemant Pandit, Professor, University of Leeds
ClinicalTrials.gov Identifier: NCT03326180     History of Changes
Other Study ID Numbers: OR16/88494
2016-003154-32 ( EudraCT Number )
197936 ( Other Identifier: Integrated Research Application System (IRAS) )
First Posted: October 31, 2017    Key Record Dates
Last Update Posted: April 23, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Bupivacaine
Anesthetics
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents