Arthropathy of Knee
Conditions
Brief summary
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
Detailed 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 .
Interventions
DRUGDexamethasone Sodium Phosphate
intravenous injection of one ampoule dexamethasone Sodium phosphate 2 ml 8 mg
DRUGSaline Solution
intravenous injection of one ampoule saline
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain summarized in the first 14 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Thigh circumference in the first 14 days | 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 |
| postoperative nausea and vomiting in the first 14 days | 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. |
| postoperative knee flexion in the first 14 days | 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. |
| Surgical wound infection in the first 14 days | 14 days | wound complications like infection to be reported: redness, discharge, infection, dehiscence, delayed healing (up to 2 wks) postoperatively |
Contacts
Primary ContactDavid Nady, physician
Backup Contactmohammed abdelnasser, Doctor
Outcome results
None listed