The Effect of Regional Anaesthesia and Genetic Factors in the Development of Chronic Pain Following Total Knee Arthroplasty

Study Overview
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Brief Summary
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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.

Official Title
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The Effect of Regional Anaesthesia and Genetic Factors in the Development of Chronic Pain Following Total Knee Arthroplasty

Conditions
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Arthroplasty, Replacement, Knee, Chronic Pain Post-Proceduraal

Intervention / Treatment
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* Procedure: Spinal anaesthesia
* Procedure: General anaesthesia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients able to undergo a total knee arthroplasty Exclusion Criteria: age more than 75 years known case of chronic pain syndromes arthroplasty not due to osteoarthritis sensitivity to any drugs used in protocol

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: General Anaesthesia<br>Patients will receive a general anaesthetic, together with a femoral nerve block. | Procedure: General anaesthesia<br>* patients will receive a general anaesthetic and a femoral nerve block<br>|
| Active Comparator: Spinal Anaesthesia<br>Patients will receive a spinal anaesthetic | Procedure: Spinal anaesthesia<br>* Patients will receive a spinal anaesthetic<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Numerical Rating Scale on physiotherapy | Pain Numerical Rating Scale, from 0 (no pain) to 10 (severe pain) | 24 hours | 
| WOMAC Score at 3 and at 6 months | WOMAC score, ranging from 0 to 94 | 6 months | 
| WOMAC Pain Score at 3 and at 6 months | WOMAC Pain score, ranging from 0 (no pain) to 20 (severe pain on numerous activities) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morphine consumption | Morphine use postop | 24 hours | 
| Pain Numerical Rating Scale after 6 months | Pain Numerical Rating Scale at rest, from 0 (no pain) to 10 (severe pain) | 6 months | 
| Incidence of Chronic Post-surgical Pain | WOMAC pain score greater than 5 at 6 months (out of total of 20) | 6 months | 
| Change in WOMAC Score at 3 and at 6 months | change in WOMAC score, ranging from 0 to 94 | 6 months | 
| Change in WOMAC Pain Score at 3 and at 6 months | change in WOMAC Pain score, ranging from 0 (no pain) to 20 (severe pain on numerous activities) | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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arthroplasty, knee, chronic pain