Preoperative Intraarticular Injection of Methylprednisolone in Patients Scheduled for Total Knee-arthroplasty

Study Overview
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Brief Summary
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Despite improvements in analgesic treatment following total knee arthroplasty (TKA) for osteoarthrosis, a substantial part of patients still have severe acute pain after surgery. It has been suggested that preoperative degree of intraarticular inflammation is associated to postoperative degree of pain and level of function. Furthermore it is known, that patients with preoperative inflammation have hyperalgesia and severe movement related pain. The aim of this study is to investigate the effect of a preoperative intraarticular injection of Methylprednisoloneacetate in reducing acute postoperative pain after total knee arthroplasty in patients with signs of severe pre-operative inflammation and pain.

Conditions
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Hyperalgesia, Knee Joint Osteoarthrosis, Severe Movement Related Pain

Intervention / Treatment
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* Drug: Methylprednisoloneacetate
* Drug: Lidocaine
* Other: sodium chloride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 50 -80 Osteoarthrosis Scheduled for primary unilateral TKA Preoperative pain report with NRS > 5 upon walking Signs of sensitisation in knee Exclusion Criteria: Allergies to methylprednisoloneacetate, lidocaine or standard analgesic treatment Deficient written or spoken danish Impairment from psychological or neurological disease Local og systemic infection Immunodeficiency Treatment with corticosteroid within 30 days of inclusion Insulin treated diabetes mellitus Anticoagulant therapy ASA (American Society of Anaesthesia) class > 3 General anaesthesia Alchohol use > 21 units / week Pregnancy

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Methylprednisoloneacetate<br>Administration of: 1 ml methylprednisoloneacetate 40 mg/ml 5 ml lidocaine 20 mg/ml 4 ml sodium chloride 9 mg/ml as a single intraarticular injection 7 days prior to surgery. | Drug: Methylprednisoloneacetate<br> <br> * Other names: Depo-Medrol;Drug: Lidocaine<br> <br> Other: sodium chloride<br> <br> * Other names: saline;|
| Placebo Comparator: Sodium chloride<br>Administration of: 5 ml lidocaine 20 mg/ml 5 ml sodium chloride 9 mg/ml as a singe intraarticular injection 7 days prior to surgery. | Drug: Lidocaine<br> <br> Other: sodium chloride<br> <br> * Other names: saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | Pain intensity on a numeric rang scale (NRS) from 0 to 10 upon ambulation 24 hours following surgery | 24 hours postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | Pain intensity on a NRS from 0 to 10 upon ambulation 48 hours following | 48 hours postoperatively | 
| Pain | Diary-reported pain intensity on a NRS from 0 to 10 when walking. Once daily from first to fourteenth postoperative day | From day 1 to day 14 | 
| Pain | Diary-reported pain intensity on a NRS from 0 to 10 upon rest. Once daily from first to fourteenth postoperative day | From day 1 to day 14 | 
| Sensitisation | Quantitative sensory testing (temporal summation / pressure algometry) on the day of surgery and on the second postoperative day. | On day 0 and day 2 | 
| Inflammation | Measurement of C-reactive protein in blood sample on the day of surgery and on the second postoperative day. | On day 0 and day 2 | 
| Inflammation | Measurement of interleukin-6 level in knee joint fluid on the day of surgery. | On day 0 |