Effects of Intraarticular IL1-Ra on Pain and Inflammatory Mediators After Knee Arhroscopy

Study Overview
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Brief Summary
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This project investigates the relation between acute pain and local inflammation. Pain reported by the patients for knee arthroscopy are compared with local changes in inflammatory mediators by using microdialysis technique. Patients with moderate-to-severe pain are included in a randomized placebo-controlled trial of anakinra given intra-articularly.

Detailed Description
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The effects of the recombinant IL-1 receptor antagonist anakinra both on acute pain and post operative inflammation will be evaluated. On inclusion, pain intensity will be measured on a five-point verbal rating scale (0= no pain, 1=mild pain, 2=moderate pain, 3=severe pain, and 4=intolerable pain), and on a visual analogue scale (0-100mm). VAS scale will be repeated at 20, 40, 60, 80, 100, 120, 140, 160, 180 and 200 minutes after inclusion / intervention. The patients will also rate pain intensity during a 5 meters walk at 200 minutes (evoked pain). The patient will rate pain at rest and evoked pain 24, 48 and 72 h after intervention.

Official Title
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Effects of Intraarticular IL1-Ra on Pain and Inflammatory Mediators After Knee Arhroscopy -a Double Blind, Placebo Controlled Study Using Microdialysis Technique

Conditions
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Knee Injuries

Intervention / Treatment
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* Drug: Anakinra 100 mg in 2 ml saline IA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Otherwise healthy patients (ASA 1 and 2) undergoing knee arthroscopy in general anaesthesia. Being informed about and willing to participate in the study - Exclusion Criteria: Pregnancy or lactation. Fertile women will be asked if they may be pregnant, and offered a pregnancy test if there is doubt. Established osteoarthritis or synovitis Known intolerance to anakinra Kidney failure (Creatinine clearance <30ml/min) History of frequent infectious diseases or immunodeficiency Heart failure History of drug -or alcohol abuse Participation in other synchronous clinical trials Perioperative steroid treatment, perioperative paracetamol (12 hrs), NSAIDs (24 hrs) or COX2-inhibitors (48 hrs). Use of tourniquet for bloodless field Strong preoperative pain (VRS ≥3) Intolerable postoperative pain (VRS=4)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anakinra<br>Anakinra 100 mg in 2 ml saline IA | Drug: Anakinra 100 mg in 2 ml saline IA<br> <br> * Other names: Kineret;|
| Placebo Comparator: Placebo<br>Saline 2 ml IA | Drug: Anakinra 100 mg in 2 ml saline IA<br> <br> * Other names: Kineret;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain relief | Selv reported pain | 72h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resuce analgesic drug consumption | Need for and consumption of resuce analgesic drug | 72h | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain, inflammation, surgery