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

NCT01997138 | Withdrawn Phase 4

• 1 other identifier: anakinrapain1
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Injuries

Keywords

pain, inflammation, surgery

Outcome Measures

Primary Outcomes (1)

• Pain relief

  Selv reported pain

  72h

Secondary Outcomes (1)

• Resuce analgesic drug consumption

  72h

Other Outcomes (1)

• Side effects

  72h

Study Arms (2)

Anakinra

EXPERIMENTAL

Anakinra 100 mg in 2 ml saline IA

Drug: Anakinra 100 mg in 2 ml saline IA

Placebo

PLACEBO COMPARATOR

Saline 2 ml IA

Drug: Anakinra 100 mg in 2 ml saline IA

Interventions

Anakinra 100 mg in 2 ml saline IA DRUG

Also known as: Kineret

Anakinra; Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Otherwise healthy patients (ASA 1 and 2) undergoing knee arthroscopy in general anaesthesia.
• Being informed about and willing to participate in the study -

You may not qualify if:

• 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)

Sponsors & Collaborators

• Oslo University Hospital: lead
• University of Oslo: collaborator
• Lovisenberg Diakonale Hospital: collaborator

Study Sites (1)

Lovisenberg Diakonal Hospital

Oslo, 0855, Norway

Location

MeSH Terms

Conditions

Knee Injuries; Pain; Inflammation

Interventions

Interleukin 1 Receptor Antagonist Protein

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor MD

Study Record Dates

• First Submitted: November 22, 2013
• First Posted: November 27, 2013
• Study Start: March 1, 2016
• Primary Completion: January 1, 2018
• Study Completion: September 1, 2018
• Last Updated: June 11, 2021

Record last verified: 2021-06

Locations

NO (1)