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

Hyperalgesia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02253966
• Other study ID #: H-3-2014-089
• Status: Completed
• Phase: Phase 2
• First received: September 29, 2014
• Last updated: June 3, 2016
• Start date: October 2014
• Est. completion date: March 2016

Study information

• Verified date: June 2016
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Health and Medicines Authority
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hyperalgesia
• Joint Diseases
• Knee Joint Osteoarthrosis
• Osteoarthritis
• Severe Movement Related Pain

Intervention

Drug:
• Methylprednisoloneacetate

• Lidocaine

Other:
• sodium chloride

Locations

Country	Name	City	State
Denmark	Gentofte Hospital	Hellerup

Sponsors (2)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Lundbeck Foundation

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain	Pain intensity on a numeric rang scale (NRS) from 0 to 10 upon ambulation 24 hours following surgery	24 hours postoperatively	No
Secondary	Pain	Pain intensity on a NRS from 0 to 10 upon ambulation 48 hours following	48 hours postoperatively	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	Yes
Secondary	Inflammation	Measurement of interleukin-6 level in knee joint fluid on the day of surgery.	On day 0	Yes