Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02253966
Recruitment Status : Completed
First Posted : October 1, 2014
Last Update Posted : June 6, 2016
Sponsor:
Collaborator:
Lundbeck Foundation
Information provided by (Responsible Party):
Iben Engelund Luna, Rigshospitalet, Denmark

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Knee Joint Osteoarthrosis Hyperalgesia Severe Movement Related Pain Drug: Methylprednisoloneacetate Drug: Lidocaine Other: sodium chloride Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Study Start Date : October 2014
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016


Arm Intervention/treatment
Active Comparator: Methylprednisoloneacetate

Administration of:

1 ml methylprednisoloneacetate 40 mg/ml 5 ml lidocaine 20 mg/ml 4 ml sodium chloride 9 mg/ml as a single intraarticular injection 7 days prior to surgery.

Drug: Methylprednisoloneacetate
Other Name: Depo-Medrol

Drug: Lidocaine
Other: sodium chloride
Other Name: saline

Placebo Comparator: Sodium chloride

Administration of:

5 ml lidocaine 20 mg/ml 5 ml sodium chloride 9 mg/ml as a singe intraarticular injection 7 days prior to surgery.

Drug: Lidocaine
Other: sodium chloride
Other Name: saline




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02253966


Locations
Layout table for location information
Denmark
Gentofte Hospital
Hellerup, Denmark, 2900
Sponsors and Collaborators
Rigshospitalet, Denmark
Lundbeck Foundation
Layout table for additonal information
Responsible Party: Iben Engelund Luna, MD, Research Fellow, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT02253966    
Other Study ID Numbers: H-3-2014-089
First Posted: October 1, 2014    Key Record Dates
Last Update Posted: June 6, 2016
Last Verified: June 2016
Additional relevant MeSH terms:
Layout table for MeSH terms
Osteoarthritis
Hyperalgesia
Somatosensory Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Methylprednisolone Acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Lidocaine
Prednisolone hemisuccinate
Prednisolone phosphate
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action