Skip to main content
OpenTrials
Completed

NCT Number: NCT02253966

Preoperative Intraarticular Injection of Methylprednisolone in Patients Scheduled for Total Knee-arthroplasty

Despite improvements in analgesic treatment following total knee arthroplasty (TKA) for osteoarthrosis, a substantial part of patients still have severe acute pain after surgery. It has been suggested that preoperative degree of intraarticular inflammation is associated to postoperative degree of pain and level of function. Furthermore it is known, that patients with preoperative inflammation have hyperalgesia and severe movement related pain.

The aim of this study is to investigate the effect of a preoperative intraarticular injection of Methylprednisoloneacetate in reducing acute postoperative pain after total knee arthroplasty in patients with signs of severe pre-operative inflammation and pain.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Knee Joint Osteoarthrosis Hyperalgesia Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Sensation Disorders Severe Movement Related Pain Signs and Symptoms Somatosensory Disorders

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Gentofte Hospital

Hellerup, 2900, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 50 -80
  • Osteoarthrosis
  • Scheduled for primary unilateral TKA
  • Preoperative pain report with NRS > 5 upon walking
  • Signs of sensitisation in knee

Exclusion criteria

  • Allergies to methylprednisoloneacetate, lidocaine or standard analgesic treatment
  • Deficient written or spoken danish
  • Impairment from psychological or neurological disease
  • Local og systemic infection
  • Immunodeficiency
  • Treatment with corticosteroid within 30 days of inclusion
  • Insulin treated diabetes mellitus
  • Anticoagulant therapy
  • ASA (American Society of Anaesthesia) class > 3
  • General anaesthesia
  • Alchohol use > 21 units / week
  • Pregnancy

Treatment and study plan

Methylprednisoloneacetate

Drug

Other names: Depo-Medrol

Lidocaine

Drug

Sodium Chloride

Other

Other names: saline

Primary outcomes

  1. Pain

    Time frame: 24 hours postoperatively

    Pain intensity on a numeric rang scale (NRS) from 0 to 10 upon ambulation 24 hours following surgery

Secondary outcomes

  1. Pain

    Time frame: 48 hours postoperatively

    Pain intensity on a NRS from 0 to 10 upon ambulation 48 hours following

  2. Pain

    Time frame: From day 1 to day 14

    Diary-reported pain intensity on a NRS from 0 to 10 when walking. Once daily from first to fourteenth postoperative day

  3. Pain

    Time frame: From day 1 to day 14

    Diary-reported pain intensity on a NRS from 0 to 10 upon rest. Once daily from first to fourteenth postoperative day

  4. Sensitisation

    Time frame: On day 0 and day 2

    Quantitative sensory testing (temporal summation / pressure algometry) on the day of surgery and on the second postoperative day.

  5. Inflammation

    Time frame: On day 0 and day 2

    Measurement of C-reactive protein in blood sample on the day of surgery and on the second postoperative day.

  6. Inflammation

    Time frame: On day 0

    Measurement of interleukin-6 level in knee joint fluid on the day of surgery.

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • Lundbeck Foundation

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Oct 1, 2014
Registry last updated
Jun 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.