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ISRCTN
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ISRCTN96095682
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DOI
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10.1186/ISRCTN96095682
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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Arthroplasty Pain Experience (APEX) Study
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Scientific title
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A randomised controlled trial to determine if local wound infiltration reduces chronic pain after lower limb arthroplasty
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Acronym
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APEX study
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Serial number at source
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7664
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Study hypothesis
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Joint replacement is one of the most common elective surgical procedures performed in the NHS. However, previous research indicates that between 10 - 30% of patients experience chronic pain after hip and knee replacement. Therefore, more research is required to explore methods of minimising chronic pain after joint replacement. The aim of this study is to determine whether an injection of local anaesthethic into the hip or knee during joint replacement surgery, in addition to standard anaesthetic, reduces long-term pain.
To do this, 300 patients listed for knee replacement and 300 patients listed for hip replacement at the Avon Orthopaedic Centre will be recruited into a randomised controlled trial. Participants will complete questionnaires to assess their joint pain and function, psychological status, and use of healthcare resources. Participants will complete questionnaires before their operation, and then at regular intervals after their operation, while they are an in-patient.
Following discharge from hospital, participants will be asked to complete postal questionnaires at 3-months and 6-months after surgery. At 12-months after surgery, participants will be asked to complete a final questionnaire and undergo a joint assessment with a research nurse. Also a small number of participants and health care professionals will be interviewed about their participation in the study, in order to find out how participation in the trial affects them.
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Lay summary
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Not provided at time of registration
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Ethics approval
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Southampton and South West Hampshire REC (B) approved on the 27th August 2009 (ref: 09/H0504/94)
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Study design
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Randomised interventional treatment trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Topic: Musculoskeletal; Subtopic: Musculoskeletal (all Subtopics); Disease: Musculoskeletal
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Participants - inclusion criteria
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1. Patients undergoing primary total hip replacement or primary total knee replacement for osteoarthritis at the Avon Orthopaedic Centre
2. Are willing and able to provide fully informed consent and complete the study questionnaires
3. Male and female, lower age limit of 18 years
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Participants - exclusion criteria
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1. Patients undergoing revision joint replacement
2. Patients undergoing joint replacement for a diagnosis other than osteoarthritis
3. Patients under the age of 18 years
4. Patients with any medical comorbidity that precludes spinal anaesthetic, regional blocks or the use of strong analgesics postoperatively
5. Diagnosis of severe dementia or psychiatric illness such that they are unable to complete the questionnaires or provide informed consent
6. Patients undergoing stimulatenous bilateral joint replacement
7. Patients who have been in the trial for a previous joint replacement
8. Patients who are unable to understand English will be exclude because not all the validated questionnaires have been translated into languages other than English
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Anticipated start date
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25/11/2009
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Anticipated end date
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01/09/2010
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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Planned Sample Size: 600
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Interventions
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Participants randomised to the interventional arm of the trial will receive a local wound infiltration, in addition to the standard anaesthetic regimen during surgery. The local anaesthetic mixture will consist of 60 ml of 0.25% bupivicaine with 1 in 200,000 adrenaline.
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Primary outcome measure(s)
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The WOMAC Pain score at 12-months post-operative.
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Secondary outcome measure(s)
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1. Length of hospital stay
2. Daily 100mm Visual Analogue Scale (VAS) ratings while an in-patient (starting the day after surgery until discharge or day 5 after surgery)
3. Western Ontario and McMaster Universities Arthritis Index (WOMAC) Function and Stiffness Scale
4. Intermittent and Constant Osteoarthritis Pain (ICOAP) pain measure
5. Pressure pain thresholds of the volar forearm will be measured using pressure algometry pre-operatively, at discharge from hospital and 12-month and post-operative
6. Resource use: Health service resource use including staff time and other resources used in the intervention, inpatient stays, outpatient visits and general practitioner visits, will be collected using hospital records and participant self-completed questionnaires (including the EQ-5D). These questionnaires will be administered at 3, 6 and 12 months post-operatively and will also be used to measure the time and travel of the patient and the carer if applicable.
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Sources of funding
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National Institute for Health Research (NIHR) (UK) - Central Commissioning Facility (CCF)
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Trial website
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Publications
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1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21352559
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Contact name
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Miss
Vicky
Wylde
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Address
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Bristol Implant Research Centre
Southmead Hospital
Southmead Road
Westbury-On-Trym
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City/town
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Bristol
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Zip/Postcode
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BS10 5NB
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Country
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United Kingdom
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Sponsor
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Southmead Hospital (UK)
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Address
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Southmead Road
Westbury-On-Trym
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City/town
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Bristol
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Zip/Postcode
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BS10 5NB
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Country
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United Kingdom
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Email
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helen.lewis@nbt.nhs.uk
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Sponsor website:
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http://www.nbt.nhs.uk/
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Date applied
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29/04/2010
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Last edited
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04/07/2011
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Date ISRCTN assigned
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29/04/2010
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