A study of pain after knee arthroscopy, an investigation of the connection between pain and inflammation, and whether the drug anakinra can relieve the pai

• Conditions: Post operative pain after diagnostic or therapeutic knee arthroscopy; MedDRA version: 16.0Level: HLGTClassification code 10023213Term: Joint disordersSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2013-002123-41-NO
• Lead Sponsor: ovisenberg Diaconal Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07-29
• Last Update Posted: 4 November 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Otherwise healthy patients between 18 and 70 years undergoing diagnostic or therapeutic knee arthroscopy.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

1.Pregnancy or lactation
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 steroidtreatment, perioperative acetaminophen (12 hrs), NSAIDs (24 hrs) or COX2-inhibitors (48 hrs).
10.Use of tourniquet for bloodless field
11.Strong preoperative pain
12.Intolerable postoperative pain (VRS=4)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified