Clinical trial NCT04084912: Effect of Preoperative Steroid in Total Knee Arthroplasty
Official title: The Effect of Preoperative Steroids Injection on Pain and Oedema After Total Knee Arthroplasty . A Double -Blinded Randomized Controlled Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Arthropathy of Knee
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-09-10
Enrollment: 86
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 .

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative pain summarized in the first 14 days
timeFrame: 14 days
Secondary outcomes:
measure: Postoperative Thigh circumference in the first 14 days
timeFrame: 14 days
measure: postoperative nausea and vomiting in the first 14 days
timeFrame: 14 days
measure: postoperative knee flexion in the first 14 days
timeFrame: 14 days
measure: Surgical wound infection in the first 14 days
timeFrame: 14 days
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Hatem Bakr, asst. prof
role: STUDY_CHAIR
References:
citation: Xing LZ, Li L, Zhang LJ. Can intravenous steroid administration reduce postoperative pain scores following total knee arthroplasty?: A meta-analysis. Medicine (Baltimore). 2017 Jun;96(24):e7134. doi: 10.1097/MD.0000000000007134.
citation: Rytter S, Stilling M, Munk S, Hansen TB. Methylprednisolone reduces pain and decreases knee swelling in the first 24 h after fast-track unicompartmental knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2017 Jan;25(1):284-290. doi: 10.1007/s00167-014-3501-8. Epub 2015 Jan 7.
citation: Fan Z, Ma J, Kuang M, Zhang L, Han B, Yang B, Wang Y, Ma X. The efficacy of dexamethasone reducing postoperative pain and emesis after total knee arthroplasty: A systematic review and meta-analysis. Int J Surg. 2018 Apr;52:149-155. doi: 10.1016/j.ijsu.2018.02.043. Epub 2018 Feb 23.
citation: Meng J, Li L. The efficiency and safety of dexamethasone for pain control in total joint arthroplasty: A meta-analysis of randomized controlled trials. Medicine (Baltimore). 2017 Jun;96(24):e7126. doi: 10.1097/MD.0000000000007126.
citation: Yue C, Wei R, Liu Y. Perioperative systemic steroid for rapid recovery in total knee and hip arthroplasty: a systematic review and meta-analysis of randomized trials. J Orthop Surg Res. 2017 Jun 27;12(1):100. doi: 10.1186/s13018-017-0601-4.