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

Knee Injuries Clinical Trial

Official title:

Effects of Intraarticular IL1-Ra on Pain and Inflammatory Mediators After Knee Arhroscopy -a Double Blind, Placebo Controlled Study Using Microdialysis Technique

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01997138
• Other study ID #: anakinrapain1
• Status: Withdrawn
• Phase: Phase 4
• Start date: March 2016
• Est. completion date: September 2018

Study information

• Verified date: June 2021
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Knee Injuries

Intervention

Drug:
• Anakinra 100 mg in 2 ml saline IA

Locations

Country	Name	City	State
Norway	Lovisenberg Diakonal Hospital	Oslo

Sponsors (3)

Lead Sponsor	Collaborator
Oslo University Hospital	Lovisenberg Diakonale Hospital, University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Side effects	Selv reported side effect according to CRF	72h
Primary	Pain relief	Selv reported pain	72h
Secondary	Resuce analgesic drug consumption	Need for and consumption of resuce analgesic drug	72h