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

Phase 2

Completed

• Conditions: Knee Joint Osteoarthrosis; Hyperalgesia; Severe Movement Related Pain
• Interventions: Drug: Methylprednisoloneacetate; Drug: Lidocaine; Other: sodium chloride

• Registration Number: NCT02253966
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-09-29
• Study First Submitted QC: 2014-09-30
• Study Start: 2014-10
• Study First Posted: 2014-10-01
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-03
• Last Update Posted: 2016-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Methylprednisoloneacetate	Lidocaine	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.
Methylprednisoloneacetate	sodium chloride	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.
Sodium chloride	Lidocaine	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.
Sodium chloride	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.
Methylprednisoloneacetate	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Sensitisation	On day 0 and day 2	Quantitative sensory testing (temporal summation / pressure algometry) on the day of surgery and on the second postoperative day.
Pain	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
Inflammation	On day 0	Measurement of interleukin-6 level in knee joint fluid on the day of surgery.

Trial Locations

Locations (1)

Gentofte Hospital; 🇩🇰 Hellerup, Denmark