Overview

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

Status:
Withdrawn

Trial end date:
2018-09-01

Target enrollment:
0

Participant gender:
All

Summary

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.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Oslo University Hospital

Collaborators:

Lovisenberg Diakonale Hospital
University of Oslo

Treatments:

Interleukin 1 Receptor Antagonist Protein

Criteria

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)