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WithdrawnNCT01997138Updated Jun 11, 2021

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

A Phase 4 interventional study of Anakinra 100 mg in 2 ml saline IA in Knee Injuries, sponsored by Oslo University Hospital. Withdrawn at 1 site in Norway. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-06-11.

Sponsored by Oslo University Hospital · Phase 4, Interventional, and Treatment

Why this study was withdrawn
Too few recruitable patients
Phase
Phase 4
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the detailed description

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.

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Conditions studied

  • Knee Injuries

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Keywords

  • pain, inflammation, surgery
03

In context

Knee Injuries

249 studies on the registry are indexed under Knee Injuries; 48 are open to participants now.

Browse Knee Injuries studies →

Lead sponsor

Oslo University Hospital is the lead sponsor of 810 studies on the registry; 148 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Anakinra

    Anakinra 100 mg in 2 ml saline IA

    Drug: Anakinra 100 mg in 2 ml saline IA

  • Placebo comparator
    Placebo

    Saline 2 ml IA

    Drug: Anakinra 100 mg in 2 ml saline IA

Interventions

  • DrugAnakinra 100 mg in 2 ml saline IA

    Also known as: Kineret

06

What researchers measure

Primary outcomes

  1. Pain relief

    Selv reported pain

    Time frame: 72h

Secondary outcomes

  1. Resuce analgesic drug consumption

    Need for and consumption of resuce analgesic drug

    Time frame: 72h

Other outcomes

  1. Side effects

    Selv reported side effect according to CRF

    Time frame: 72h

07

Study locations

1 site
  • Lovisenberg Diakonal Hospital
    Oslo, 0855, Norway
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 11, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01997138
Lead sponsor
Oslo University Hospital
Collaborators
University of Oslo, Lovisenberg Diakonale Hospital
Responsible party
Leiv Arne Rosseland (Professor MD, Oslo University Hospital) — Principal investigator
First posted
Nov 27, 2013
Start date
Mar 2016
Primary completion
Jan 2018 (estimated)
Completion
Sep 2018 (estimated)
Last update
Jun 11, 2021

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.

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