The Effect of Regional Anaesthesia and Genetic Factors in the Development of Chronic Pain Following Total Knee Arthroplasty
- Conditions
- Arthroplasty, Replacement, KneeChronic Pain Post-Proceduraal
- Registration Number
- NCT04206046
- Lead Sponsor
- Sciberras, Stephen M.D.
- Brief Summary
The study aims to assess the effect of spinal anaesthesia against a general anaesthesia with a femoral block, with respect to the incidence of chronic pain following a total knee replacement.
It will also focus on genetic factors and their influence on chronic pain.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 200
- patients able to undergo a total knee arthroplasty
- age more than 75 years
- known case of chronic pain syndromes
- arthroplasty not due to osteoarthritis
- sensitivity to any drugs used in protocol
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Pain Numerical Rating Scale on physiotherapy 24 hours Pain Numerical Rating Scale, from 0 (no pain) to 10 (severe pain)
WOMAC Score at 3 and at 6 months 6 months WOMAC score, ranging from 0 to 94
WOMAC Pain Score at 3 and at 6 months 6 months WOMAC Pain score, ranging from 0 (no pain) to 20 (severe pain on numerous activities)
- Secondary Outcome Measures
Name Time Method Incidence of Chronic Post-surgical Pain 6 months WOMAC pain score greater than 5 at 6 months (out of total of 20)
Pain Numerical Rating Scale after 6 months 6 months Pain Numerical Rating Scale at rest, from 0 (no pain) to 10 (severe pain)
Change in WOMAC Score at 3 and at 6 months 6 months change in WOMAC score, ranging from 0 to 94
Change in WOMAC Pain Score at 3 and at 6 months 6 months change in WOMAC Pain score, ranging from 0 (no pain) to 20 (severe pain on numerous activities)
Morphine consumption 24 hours Morphine use postop
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Trial Locations
- Locations (1)
Mater Dei Hospital
🇲🇹Imsida, Malta
Mater Dei Hospital🇲🇹Imsida, Malta