Title

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

    Phase 4
  • Study Type

    Interventional
  • Status

    Withdrawn
  • Intervention/Treatment

    anakinra ...
  • Study Participants

    0
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.
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.
Study Started
Mar 31
2016
Primary Completion
Jan 31
2018
Anticipated
Study Completion
Sep 30
2018
Anticipated
Last Update
Jun 11
2021

Drug Anakinra 100 mg in 2 ml saline IA

  • Other names: Kineret

Anakinra Experimental

Anakinra 100 mg in 2 ml saline IA

Placebo Placebo Comparator

Saline 2 ml IA

Criteria

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)
No Results Posted