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

Effects of intraarticular IL1-Ra on pain and inflammatory mediators after knee arthroscopy –a double blind, placebo controlled study using microdialysis technique

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-002123-41-NO

Enrollment

Registered

2013-07-29

Start date

2013-10-21

Completion date

Unknown

Last updated

2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post operative pain after diagnostic or therapeutic knee arthroscopy MedDRA version: 16.0 Level: HLGT Classification code 10023213 Term: Joint disorders System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Interventions

Trade Name: Kineret Product Name: Kineret Product Code: EMEA/H/C/000363 Pharmaceutical Form: Injection Pharmaceutical form of the placebo: Injection Route of administration of the placebo: Intraarticu

Eligibility

Sex/Gender

All

Inclusion criteria

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

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)

Design outcomes

Primary

Measure	Time frame
Main Objective: To examine the postoperative pain relieving effects of anakinra compared to placebo;Secondary Objective: Biomarkers of inflammation and pain;Primary end point(s): Pain is measured postoperatively using the verbal rating scale (VRS 0-4). Patients with VRS 2 or 3 are included in the intervention group receiving either active drug or placebo. Pain is then scored on the visual analogue scale (VAS) every 20 minutes during the first two postoperative hours. ;Timepoint(s) of evaluation of this end point: Pain is measured as soon as possible postoperatively using the verbal rating scale (VRS 0-4). Pain is then scored on the visual analogue scale (VAS) every 20 minutes during the first two postoperative hours.	—

Measure

Time frame

Main Objective: To examine the postoperative pain relieving effects of anakinra compared to placebo;Secondary Objective: Biomarkers of inflammation and pain;Primary end point(s): Pain is measured postoperatively using the verbal rating scale (VRS 0-4). Patients with VRS 2 or 3 are included in the intervention group receiving either active drug or placebo. Pain is then scored on the visual analogue scale (VAS) every 20 minutes during the first two postoperative hours. ;Timepoint(s) of evaluation of this end point: Pain is measured as soon as possible postoperatively using the verbal rating scale (VRS 0-4). Pain is then scored on the visual analogue scale (VAS) every 20 minutes during the first two postoperative hours.

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Secondary

Measure	Time frame
Secondary end point(s): The use of morphine is registered throughout the observation period;Timepoint(s) of evaluation of this end point: 2 hours postoperatively	—

Countries

Norway

Contacts

Public ContactHead of Surgical Department

Lovisenberg Diaconal Hospital

4723225000

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026