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Arthroplasty Pain Experience (APEX) Study

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN96095682
Enrollment
600
Registered
2010-04-29
Start date
2009-11-25
Completion date
Unknown
Last updated
2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Topic: Musculoskeletal

Interventions

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 wi

Sponsors

Southmead Hospital (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
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.

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 29, 2026