Back to resultsEffects of Intraarticular IL1-Ra on Pain and Inflammatory Mediators After Knee Arhroscopy
Primary Purpose
Knee Injuries
Status
Withdrawn
Phase
Phase 4
Locations
Norway
Study Type
Interventional
Intervention
Anakinra 100 mg in 2 ml saline IA
Sponsored by
About this trial
This is an interventional treatment trial for Knee Injuries focused on measuring pain, inflammation, surgery
Eligibility Criteria
Inclusion Criteria:
- Otherwise healthy patients (ASA 1 and 2) undergoing knee arthroscopy in general anaesthesia.
- Being informed about and willing to participate in the study -
Exclusion Criteria:
- Pregnancy or lactation. Fertile women will be asked if they may be pregnant, and offered a pregnancy test if there is doubt.
- Established osteoarthritis or synovitis
- Known intolerance to anakinra
- Kidney failure (Creatinine clearance <30ml/min)
- History of frequent infectious diseases or immunodeficiency
- Heart failure
- History of drug -or alcohol abuse
- Participation in other synchronous clinical trials
- Perioperative steroid treatment, perioperative paracetamol (12 hrs), NSAIDs (24 hrs) or COX2-inhibitors (48 hrs).
- Use of tourniquet for bloodless field
- Strong preoperative pain (VRS ≥3)
- Intolerable postoperative pain (VRS=4)
Sites / Locations
- Lovisenberg Diakonal Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Anakinra
Placebo
Arm Description
Anakinra 100 mg in 2 ml saline IA
Saline 2 ml IA
Outcomes
Primary Outcome Measures
Pain relief
Selv reported pain
Secondary Outcome Measures
Resuce analgesic drug consumption
Need for and consumption of resuce analgesic drug
Full Information
NCT ID
NCT01997138
First Posted
November 22, 2013
Last Updated
June 9, 2021
Sponsor
Oslo University Hospital
Collaborators
University of Oslo, Lovisenberg Diakonale Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01997138
Brief Title
Effects of Intraarticular IL1-Ra on Pain and Inflammatory Mediators After Knee Arhroscopy
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 Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Too few recruitable patients
Study Start Date
March 2016 (undefined)
Primary Completion Date
January 2018 (Anticipated)
Study Completion Date
September 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
Collaborators
University of Oslo, Lovisenberg Diakonale Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Injuries
Keywords
pain, inflammation, surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Anakinra
Arm Type
Experimental
Arm Description
Anakinra 100 mg in 2 ml saline IA
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Saline 2 ml IA
Intervention Type
Drug
Intervention Name(s)
Anakinra 100 mg in 2 ml saline IA
Other Intervention Name(s)
Kineret
Primary Outcome Measure Information:
Title
Pain relief
Description
Selv reported pain
Time Frame
72h
Secondary Outcome Measure Information:
Title
Resuce analgesic drug consumption
Description
Need for and consumption of resuce analgesic drug
Time Frame
72h
Other Pre-specified Outcome Measures:
Title
Side effects
Description
Selv reported side effect according to CRF
Time Frame
72h
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Otherwise healthy patients (ASA 1 and 2) undergoing knee arthroscopy in general anaesthesia.
Being informed about and willing to participate in the study -
Exclusion Criteria:
Pregnancy or lactation. Fertile women will be asked if they may be pregnant, and offered a pregnancy test if there is doubt.
Established osteoarthritis or synovitis
Known intolerance to anakinra
Kidney failure (Creatinine clearance <30ml/min)
History of frequent infectious diseases or immunodeficiency
Heart failure
History of drug -or alcohol abuse
Participation in other synchronous clinical trials
Perioperative steroid treatment, perioperative paracetamol (12 hrs), NSAIDs (24 hrs) or COX2-inhibitors (48 hrs).
Use of tourniquet for bloodless field
Strong preoperative pain (VRS ≥3)
Intolerable postoperative pain (VRS=4)
Facility Information:
Facility Name
Lovisenberg Diakonal Hospital
City
Oslo
ZIP/Postal Code
0855
Country
Norway
12. IPD Sharing Statement
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Effects of Intraarticular IL1-Ra on Pain and Inflammatory Mediators After Knee Arhroscopy
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