Effect of Preoperative Steroid in Total Knee Arthroplasty
Paraules clau
Resum
Descripció
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 .
Dates
| Darrera verificació: | 11/30/2019 |
| Primer enviat: | 09/04/2019 |
| Inscripció estimada enviada: | 09/06/2019 |
| Publicat per primera vegada: | 09/09/2019 |
| Última actualització enviada: | 12/18/2019 |
| Publicació de l'última actualització: | 12/22/2019 |
| Data d'inici de l'estudi real: | 12/31/2019 |
| Data estimada de finalització primària: | 12/31/2020 |
| Data estimada de finalització de l’estudi: | 05/31/2021 |
Condició o malaltia
Intervenció / tractament
Drug: Dexamethasone group
Drug: Placebo group
Fase
Grups de braços
| Braç | Intervenció / tractament |
|---|---|
| Active Comparator: Dexamethasone group 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 group intravenous injection of one ampoule dexamethasone Sodium phosphate 2 ml 8 mg |
| Placebo Comparator: Placebo group this group will receive one ampoule Intravenous injection of Saline once by the anesthesiologist immediately before skin incision | Drug: Placebo group intravenous injection of one ampoule saline |
Criteris d'elegibilitat
| Sexes elegibles per estudiar | All |
| Accepta voluntaris saludables | Sí |
| Criteris | 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 |
Resultat
Mesures de resultats primaris
1. Postoperative pain summarized in the first 14 days [14 days]
Mesures de resultats secundaris
1. Postoperative Thigh circumference in the first 14 days [14 days]
2. postoperative nausea and vomiting in the first 14 days [14 days]
3. postoperative knee flexion in the first 14 days [14 days]
4. Surgical wound infection in the first 14 days [14 days]
