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

Rigshospitalet

Status and phase: Completed; Phase 2

Conditions: Hyperalgesia; Severe Movement Related Pain; Knee Joint Osteoarthrosis

Treatments: Drug: Lidocaine; Drug: Methylprednisoloneacetate; Other: sodium chloride

Study type: Interventional

Funder types: Other

Identifiers

NCT02253966

H-3-2014-089

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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48 participants in 2 patient groups, including a placebo group

Methylprednisoloneacetate

Active Comparator group

Description:

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.

Treatment:

Other: sodium chloride

Drug: Methylprednisoloneacetate

Drug: Lidocaine

Sodium chloride

Placebo Comparator group

Description:

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.

Treatment:

Other: sodium chloride

Drug: Lidocaine