Trials / Withdrawn
WithdrawnNCT01997138
Effects of Intraarticular IL1-Ra on Pain and Inflammatory Mediators After Knee Arhroscopy
Effects of Intraarticular IL1-Ra on Pain and Inflammatory Mediators After Knee Arhroscopy -a Double Blind, Placebo Controlled Study Using Microdialysis Technique
- Status
- Withdrawn
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Oslo University Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Anakinra 100 mg in 2 ml saline IA |
Timeline
- Start date
- 2016-03-01
- Primary completion
- 2018-01-01
- Completion
- 2018-09-01
- First posted
- 2013-11-27
- Last updated
- 2021-06-11
Locations
1 site across 1 country: Norway
Source: ClinicalTrials.gov record NCT01997138. Inclusion in this directory is not an endorsement.