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Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01997138

Enrollment

Registered

2013-11-27

Start date

2016-03-31

Completion date

2018-09-30

Last updated

2021-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Injuries

Keywords

pain, inflammation, surgery

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.

Interventions

DRUGAnakinra 100 mg in 2 ml saline IA

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
Pain relief	72h	Selv reported pain

Secondary

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

Other

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

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026