Arthroplasty Pain Experience (APEX) Study

ISRCTN	ISRCTN96095682
DOI	https://doi.org/10.1186/ISRCTN96095682
Protocol serial number	7664
Sponsor	Southmead Hospital (UK)
Funder	National Institute for Health Research (NIHR) (UK) - Central Commissioning Facility (CCF)

Submission date: 29/04/2010
Registration date: 29/04/2010
Last edited: 04/01/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Miss Vicky Wylde
Scientific

Bristol Implant Research Centre
Southmead Hospital
Southmead Road
Westbury-On-Trym
Bristol
BS10 5NB
United Kingdom

Study information

Primary study design	Interventional
Study design	Randomised interventional treatment trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	A randomised controlled trial to determine if local wound infiltration reduces chronic pain after lower limb arthroplasty
Study acronym	APEX study
Study objectives	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.
Ethics approval(s)	Southampton and South West Hampshire REC (B), 27/08/2009, ref: 09/H0504/94
Health condition(s) or problem(s) studied	Topic: Musculoskeletal; Subtopic: Musculoskeletal (all Subtopics); Disease: Musculoskeletal
Intervention	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.
Intervention type	Other
Primary outcome measure(s)	The WOMAC Pain score at 12-months post-operative.
Key secondary outcome measure(s)	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.
Completion date	01/09/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	600
Key inclusion criteria	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
Key exclusion criteria	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
Date of first enrolment	25/11/2009
Date of final enrolment	01/09/2010

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Southmead Hospital

Bristol
BS10 5NB
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	26/02/2011		Yes	No
Results article	results	26/06/2015		Yes	No
HRA research summary			28/06/2023	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes