Effect of Preoperative Steroid in Total Knee Arthroplasty

Study Overview
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Brief Summary
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Detect the effect of preoperative steroid injection in total knee arthroplasty on post operative: pain oedema nausea and vomiting quadriceps power knee flexion wound complications

Detailed Description
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Total knee arthroplasty has been identified as one of the most effective surgeries for knee arthritis. Many patients experience moderate to severe pain during the early postoperative period, as the surgery involves extensive bone resection and postsurgical serum levels of cytokine interleukin-6 and C-reactive protein may be elevated.Furthermore, many patients suffer postoperative nausea and vomiting after total knee arthroplasty . The inflammatory response after TKA is pronounced and a result of cumulative effects of anaesthesia and mechanical stress . Inadequate management of postoperative pain is relevant with a series of undesirable effects, including progression to a persistent pain, delayed functional recovery, increased the economic burden and patient dissatisfaction. Steroids may be associated with decreased levels of interleukin-6 and C reactive protein and may, thus, relieve the pain associated with surgery. Dexamethasone is a long-acting glucocorticoid that has been reported to inhibit peripheral phospholipase A, which decreases the pain-aggravating agents from the cyclooxygenase and lipoxygenase pathways . In addition, it reduces postoperative nausea and vomiting by exerting a central antiemetic effect by inhibiting prostaglandin synthesis and the release of endogenous opioids[5] . Some studies also reported potential adverse events, such as infection .

Official Title
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The Effect of Preoperative Steroids Injection on Pain and Oedema After Total Knee Arthroplasty . A Double -Blinded Randomized Controlled Study.

Conditions
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Arthropathy of Knee

Intervention / Treatment
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* Drug: Dexamethasone Sodium Phosphate
* Drug: Saline Solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any patient scheduled for primary total knee replacement arthroplasty Exclusion Criteria: Diabetic patients Rheumatoid arthritis patients Patients on regular steroid therapy Patients refused to be enrolled in the study
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dexamethasone group<br>this group will receive one ampoule Intravenous injection of Dexamethasone Sodium Phosphate 2 ml . 8 mg once by the anesthesiologist immediately before skin incision | Drug: Dexamethasone Sodium Phosphate<br>* intravenous injection of one ampoule dexamethasone Sodium phosphate 2 ml 8 mg<br>* Other names: Steroid;|
| Placebo Comparator: Placebo group<br>this group will receive one ampoule Intravenous injection of Saline once by the anesthesiologist immediately before skin incision | Drug: Saline Solution<br>* intravenous injection of one ampoule saline<br>* Other names: saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain summarized in the first 14 days | postoperative pain summarized over first 14 days after surgery , assessed by a summation of Visual Analog Scale (VAS)-scores at day 1 , day 2 , day 3 and day 14 after surgery pain is monitored by Visual Analog Scale (VAS) 0-100 mm, where 0 is no pain and 100 is the worst pain one can imagine Moderate pain is considered a VAS >30 mm. | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Thigh circumference in the first 14 days | Postoperative oedema will be assessed for all participants by measuring Thigh circumference 1 cm above the upper pole of the patella postoperatively at day 1,2,3 and 14 | 14 days | 
| postoperative nausea and vomiting in the first 14 days | postoperative nausea and vomiting summarized over first 14 days after surgery , assessed by a summation of Visual Analog Scale (VAS)-scores at day 1 , day 2 , day 3 and day 14 after surgery Nausea and vomiting is monitored by Visual Analog Scale (VAS) 0-100 mm, where 0 is no nausea nor vomiting and 100 is the worst nausea and vomiting one can imagine Moderate pain is considered a VAS >30 mm. | 14 days | 
| postoperative knee flexion in the first 14 days | Knee flexion assessed over first 14 days after surgery assessed by knee range of motion measured by goniometer where straight knee joint measure 0 degree. | 14 days | 
| Surgical wound infection in the first 14 days | wound complications like infection to be reported: redness, discharge, infection, dehiscence, delayed healing (up to 2 wks) postoperatively | 14 days |