Effect of Preoperative Steroid in Total Knee Arthroplasty

Assiut University

Status and phase: Unknown; Phase 3

Conditions: Arthropathy of Knee

Treatments: Drug: Saline Solution; Drug: Dexamethasone Sodium Phosphate

Study type: Interventional

Funder types: Other

Identifiers

NCT04084912

steroid injection in TKA

Details and patient eligibility

About

Detect the effect of preoperative steroid injection in total knee arthroplasty on post operative:

1. pain
2. oedema
3. nausea and vomiting
4. quadriceps power
5. knee flexion
6. wound complications

Full description

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 .

Enrollment: 86 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Any patient scheduled for primary total knee replacement arthroplasty

Exclusion criteria

1. Diabetic patients
2. Rheumatoid arthritis patients
3. Patients on regular steroid therapy
4. Patients refused to be enrolled in the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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86 participants in 2 patient groups, including a placebo group

Dexamethasone group

Active Comparator group

Description:

this group will receive one ampoule Intravenous injection of Dexamethasone Sodium Phosphate 2 ml . 8 mg once by the anesthesiologist immediately before skin incision

Treatment:

Drug: Dexamethasone Sodium Phosphate

Placebo group

Placebo Comparator group

Description:

this group will receive one ampoule Intravenous injection of Saline once by the anesthesiologist immediately before skin incision

Treatment:

Drug: Saline Solution