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| Name | Class |
|---|---|
| Lundbeck Foundation | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methylprednisoloneacetate | Active Comparator | 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 | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methylprednisoloneacetate | Drug |
|
| |
| Lidocaine |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gentofte Hospital | Hellerup | 2900 | Denmark |
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| Drug |
|
| sodium chloride | Other |
|
|
| 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 |
| ID | Term |
|---|---|
| D006930 | Hyperalgesia |
| ID | Term |
|---|---|
| D020886 | Somatosensory Disorders |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077555 | Methylprednisolone Acetate |
| D008012 | Lidocaine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D008775 | Methylprednisolone |
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
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