Hyperalgesia, Knee Joint Osteoarthrosis, Severe Movement Related Pain
Conditions
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.
Interventions
Sponsors
Lundbeck Foundation
Rigshospitalet, Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain | 24 hours postoperatively | Pain intensity on a numeric rang scale (NRS) from 0 to 10 upon ambulation 24 hours following surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain | 48 hours postoperatively | Pain intensity on a NRS from 0 to 10 upon ambulation 48 hours following |
| 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. |
| Inflammation | 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. |
Countries
Denmark
Outcome results
None listed