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.

Study Overview

• Status: Completed
• Conditions: Hyperalgesia; Knee Joint Osteoarthrosis; Severe Movement Related Pain
• Intervention / Treatment: Drug: Lidocaine; Other: sodium chloride; Drug: Methylprednisoloneacetate

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 2

Contacts and Locations

Study Locations

• Denmark
  • Hellerup, Denmark, 2900
    • Gentofte Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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: Lidocaine; Other: sodium chloride; Other Names: saline; Drug: Methylprednisoloneacetate; Other Names: Depo-Medrol
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 Names: saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain	Pain intensity on a numeric rang scale (NRS) from 0 to 10 upon ambulation 24 hours following surgery	24 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain	Pain intensity on a NRS from 0 to 10 upon ambulation 48 hours following	48 hours postoperatively
Pain	Diary-reported pain intensity on a NRS from 0 to 10 when walking. Once daily from first to fourteenth postoperative day	From day 1 to day 14
Pain	Diary-reported pain intensity on a NRS from 0 to 10 upon rest. Once daily from first to fourteenth postoperative day	From day 1 to day 14
Sensitisation	Quantitative sensory testing (temporal summation / pressure algometry) on the day of surgery and on the second postoperative day.	On day 0 and day 2
Inflammation	Measurement of C-reactive protein in blood sample on the day of surgery and on the second postoperative day.	On day 0 and day 2
Inflammation	Measurement of interleukin-6 level in knee joint fluid on the day of surgery.	On day 0

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Collaborators: Lundbeck Foundation

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: September 29, 2014
• First Submitted That Met QC Criteria: September 30, 2014
• First Posted (Estimate): October 1, 2014

Study Record Updates

• Last Update Posted (Estimate): June 6, 2016
• Last Update Submitted That Met QC Criteria: June 3, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Sensation Disorders; Somatosensory Disorders; Osteoarthritis; Hyperalgesia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Neuroprotective Agents; Protective Agents; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Lidocaine
• Other Study ID Numbers: H-3-2014-089