Condition category
Musculoskeletal Diseases
Date applied
29/04/2010
Date assigned
29/04/2010
Last edited
04/07/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Miss Vicky Wylde

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

7664

Study information

Scientific title

A randomised controlled trial to determine if local wound infiltration reduces chronic pain after lower limb arthroplasty

Acronym

APEX study

Study hypothesis

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

Southampton and South West Hampshire REC (B) approved on the 27th August 2009 (ref: 09/H0504/94)

Study design

Randomised interventional treatment trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

The WOMAC Pain score at 12-months post-operative.

Secondary outcome measures

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.

Overall trial start date

25/11/2009

Overall trial end date

01/09/2010

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 600

Participant 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

Recruitment start date

25/11/2009

Recruitment end date

01/09/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Bristol Implant Research Centre
Bristol
BS10 5NB
United Kingdom

Sponsor information

Organisation

Southmead Hospital (UK)

Sponsor details

Southmead Road
Westbury-On-Trym
Bristol
BS10 5NB
United Kingdom
helen.lewis@nbt.nhs.uk

Sponsor type

Hospital/treatment centre

Website

http://www.nbt.nhs.uk/

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) (UK) - Central Commissioning Facility (CCF)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21352559

Publication citations

  1. Results

    Wylde V, Gooberman-Hill R, Horwood J, Beswick A, Noble S, Brookes S, Smith AJ, Pyke M, Dieppe P, Blom AW, The effect of local anaesthetic wound infiltration on chronic pain after lower limb joint replacement: a protocol for a double-blind randomised controlled trial., BMC Musculoskelet Disord, 2011, 12, 53, doi: 10.1186/1471-2474-12-53.

Additional files

Editorial Notes