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

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.

Study Overview

• Status: Withdrawn
• Conditions: Knee Injuries
• Intervention / Treatment: Drug: Anakinra 100 mg in 2 ml saline IA

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.

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, 0855
    • Lovisenberg Diakonal Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Anakinra; Anakinra 100 mg in 2 ml saline IA	Drug: Anakinra 100 mg in 2 ml saline IA; Other Names: Kineret
Placebo Comparator: Placebo; Saline 2 ml IA	Drug: Anakinra 100 mg in 2 ml saline IA; Other Names: Kineret

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain relief	Selv reported pain	72h

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resuce analgesic drug consumption	Need for and consumption of resuce analgesic drug	72h

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Side effects	Selv reported side effect according to CRF	72h

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Collaborators: University of Oslo; Lovisenberg Diakonale Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Anticipated): January 1, 2018
• Study Completion (Anticipated): September 1, 2018

Study Registration Dates

• First Submitted: November 22, 2013
• First Submitted That Met QC Criteria: November 22, 2013
• First Posted (Estimate): November 27, 2013

Study Record Updates

• Last Update Posted (Actual): June 11, 2021
• Last Update Submitted That Met QC Criteria: June 9, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: pain, inflammation, surgery
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Knee Injuries; Antirheumatic Agents; Interleukin 1 Receptor Antagonist Protein
• Other Study ID Numbers: anakinrapain1