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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2018-09-30

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.

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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.

Conditions

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Knee Injuries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Anakinra

Anakinra 100 mg in 2 ml saline IA

Group Type EXPERIMENTAL

Anakinra 100 mg in 2 ml saline IA

Intervention Type DRUG

Placebo

Saline 2 ml IA

Group Type PLACEBO_COMPARATOR

Anakinra 100 mg in 2 ml saline IA

Intervention Type DRUG

Interventions

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Anakinra 100 mg in 2 ml saline IA

Intervention Type DRUG

Other Intervention Names

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Kineret

Eligibility Criteria

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Inclusion Criteria

1. Otherwise healthy patients (ASA 1 and 2) undergoing knee arthroscopy in general anaesthesia.
2. Being informed about and willing to participate in the study -

Exclusion Criteria

1. Pregnancy or lactation. Fertile women will be asked if they may be pregnant, and offered a pregnancy test if there is doubt.
2. Established osteoarthritis or synovitis
3. Known intolerance to anakinra
4. Kidney failure (Creatinine clearance \<30ml/min)
5. History of frequent infectious diseases or immunodeficiency
6. Heart failure
7. History of drug -or alcohol abuse
8. Participation in other synchronous clinical trials
9. Perioperative steroid treatment, perioperative paracetamol (12 hrs), NSAIDs (24 hrs) or COX2-inhibitors (48 hrs).
10. Use of tourniquet for bloodless field
11. Strong preoperative pain (VRS ≥3)
12. Intolerable postoperative pain (VRS=4)

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No