The Effect of Dexamethasone on Pain After Total Knee Replacement Surgery

Study Overview
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Brief Summary
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The purpose of this study is to examine, if a single-dose of dexamethasone given during the operation, alleviates pain after knee replacement surgery.

Detailed Description
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The purpose of this study is to examine, if a single-dose of dexamethasone given during the operation, alleviates pain after knee replacement surgery. This is also a dose-finding study comparing two doses of dexamethasone. Total knee arthroplasty causes considerable pain. Multimodal analgesia and peripheral nerve blocks are used for treatment of pain. Some studies suggest that glucocorticoids alleviate postoperative pain. The optimal dose of dexamethasone in treatment of postoperative pain is not known. Studies on this subject in patients with total knee replacement are sparse. Potential side-effects of dexamethasone (hyperglycemia, wound infection) need to be studied. Patients coming for primary knee replacement surgery are enrolled. The patients in each study group receive multimodal therapy for postoperative pain: etoricoxib, paracetamol, gabapentin and oxycodone. A single dose of intravenous dexamethasone (0,15 mg/kg or 0,25 mg/kg) or a placebo (saline) is administered to the patient during the operation. The effect of dexamethasone on postoperative pain is observed: main outcome is dynamic pain at 24 h postoperatively. The extent of inflammatory reaction is measured (CRP). Serial blood glucose measurements are done.

Official Title
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The Effect of Intravenous Single-dose Dexamethasone on Pain After Total Knee Replacement Surgery

Conditions
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Arthroplasty, Knee Replacement, Pain, Postoperative

Intervention / Treatment
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* Drug: Dexamethasone
* Drug: Sodium Chloride, (24)NaCl 0,9%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: primary total knee replacement surgery ASA (american society of anesthesiologists) class 1-3 Exclusion Criteria: severe coronary artery disease, heart failure, kidney failure insulin-dependent DM (diabetes mellitus), poorly controlled type II DM gastric/duodenal ulcer allergy/contra-indication for any drug used in the study corticosteroid use during last 3 months preoperative use of opioid drugs (excl. codeine, tramadol) neuropathy/sensory impairment of lower limbs lack of co-operation, e.g. inability to use a PCA (patient controlled analgesia)-device

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dexamethasone 0,15 mg/kg<br>single-dose intravenous dexamethasone 0,15 mg/kg, intraoperative | Drug: Dexamethasone<br>* intravenous dexamethasone, two groups: 0,15 mg/kg, 0,25 mg/kg<br>* Other names: Oradexon;|
| Experimental: dexamethasone 0,25 mg/kg<br>single-dose intravenous dexamethasone 0,25 mg/kg, intraoperative | Drug: Dexamethasone<br>* intravenous dexamethasone, two groups: 0,15 mg/kg, 0,25 mg/kg<br>* Other names: Oradexon;|
| Placebo Comparator: Sodium Chloride, (24)NaCl 0,9%<br>single-dose intravenous saline, intraoperative | Drug: Sodium Chloride, (24)NaCl 0,9%<br>* intravenous placebo<br>* Other names: saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain during walking, NRS 0-10 | NRS (numerical rating scale: 0=no pain, 10 = worst possible pain) | at 24 hours postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain at rest, NRS 0-10 | NRS (numerical rating scale: 0=no pain, 10 = worst possible pain) | preoperatively, postoperatively: at 2 hours, at 8 hours,at 24 hours, at 32 hours, at 48 hours, seventh postoperative day | 
| consumption of intravenous oxycodone, milligrams/kilogram body weight | cumulative dose of oxycodone administered with a PCA (patient-controlled analgesia)-device | postoperatively: at 2 hours, at 8 hours, at 24 hours, at 48 hours | 
| nausea, NRS 0-10 | NRS (numerical rating scale: 0=no nausea, 10 = worst possible nausea) | postoperatively: at 2 hours, at 8 hours,at 24 hours, at 32 hours, at 48 hours | 
| general wellbeing, NRS 0-10 | NRS (numerical rating scale: 0=worst, 10 = best) | postoperatively: at 2 hours, at 8 hours,at 24 hours, at 32 hours, at 48 hours | 
| quality of sleep, NRS 0-10 | NRS (numerical rating scale: 0=worst, 10 = best) | postoperatively at 24 hours, at 48 hours | 
| time to achieve discharge criteria, hours | time to achieve discharge criteria, hours | postoperatively: at 24 hours, at 48 hours, at 72 hours, at 96 hours | 
| pain during walking, NRS 0-10 | NRS (numerical rating scale: 0=no pain, 10 = worst possible pain) | preoperatively, postoperatively: at 8 hours, at 48 hours, seventh postoperative day | 
| vomiting, yes/no | vomiting, yes/no | postoperatively: at 2 hours, at 8 hours,at 24 hours, at 32 hours, at 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Arthroplasty, Knee Replacement, Pain, Postoperative, Glucocorticoids, Dexamethasone