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

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ClinicalTrials.gov Identifier: NCT01997138
Recruitment Status : Withdrawn (Too few recruitable patients)
First Posted : November 27, 2013
Last Update Posted : June 11, 2021
Sponsor:
Collaborators:
University of Oslo
Lovisenberg Diakonale Hospital
Information provided by (Responsible Party):
Leiv Arne Rosseland, Oslo University Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Knee Injuries Drug: Anakinra 100 mg in 2 ml saline IA Phase 4

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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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Intraarticular IL1-Ra on Pain and Inflammatory Mediators After Knee Arhroscopy -a Double Blind, Placebo Controlled Study Using Microdialysis Technique
Study Start Date : March 2016
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Anakinra

Arm Intervention/treatment
Experimental: Anakinra
Anakinra 100 mg in 2 ml saline IA
Drug: Anakinra 100 mg in 2 ml saline IA
Other Name: Kineret

Placebo Comparator: Placebo
Saline 2 ml IA
Drug: Anakinra 100 mg in 2 ml saline IA
Other Name: Kineret




Primary Outcome Measures :
  1. Pain relief [ Time Frame: 72h ]
    Selv reported pain


Secondary Outcome Measures :
  1. Resuce analgesic drug consumption [ Time Frame: 72h ]
    Need for and consumption of resuce analgesic drug


Other Outcome Measures:
  1. Side effects [ Time Frame: 72h ]
    Selv reported side effect according to CRF



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01997138


Locations
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Norway
Lovisenberg Diakonal Hospital
Oslo, Norway, 0855
Sponsors and Collaborators
Oslo University Hospital
University of Oslo
Lovisenberg Diakonale Hospital
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Responsible Party: Leiv Arne Rosseland, Professor MD, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01997138    
Other Study ID Numbers: anakinrapain1
First Posted: November 27, 2013    Key Record Dates
Last Update Posted: June 11, 2021
Last Verified: June 2021
Keywords provided by Leiv Arne Rosseland, Oslo University Hospital:
pain, inflammation, surgery
Additional relevant MeSH terms:
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Knee Injuries
Leg Injuries
Wounds and Injuries
Interleukin 1 Receptor Antagonist Protein
Antirheumatic Agents