ARTHROPLASTY
Effects of celecoxib on blood loss, pain, and recovery of function after total knee replacement: A randomized placebo-controlled trial
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2013;1(11):94 Acta Orthop. 2007 Oct;78(5):661-750 patients requiring total knee replacement (TKR) were randomized to receive either a placebo, or Celecoxib (200mg) preoperatively and twice daily for 3 weeks postoperatively. The primary outcome examined was perioperative blood loss, and other subjective factors were reviewed. Results demonstrated that Celecoxib does not increase perioperative blood loss, but decreases post-operative pain and opioid consumption.
Was the allocation sequence adequately generated?
Was allocation adequately concealed?
Blinding Treatment Providers: Was knowledge of the allocated interventions adequately prevented?
Blinding Outcome Assessors: Was knowledge of the allocated interventions adequately prevented?
Blinding Patients: Was knowledge of the allocated interventions adequately prevented?
Was loss to follow-up (missing outcome data) infrequent?
Are reports of the study free of suggestion of selective outcome reporting?
Were outcomes objective, patient-important and assessed in a manner to limit bias (ie. duplicate assessors, Independent assessors)?
Was the sample size sufficiently large to assure a balance of prognosis and sufficiently large number of outcome events?
Was investigator expertise/experience with both treatment and control techniques likely the same (ie.were criteria for surgeon participation/expertise provided)?
はい = 1
不確実＝0.5
無関係 = 0
いいえ = 0
報告基準評価では、著者が出版物内で試験の方法論的特徴や試験特性を報告する際の透明性を評価します。評価は以下の5つのカテゴリーに分類されます。
4/4
Randomization
4/4
Outcome Measurements
2/4
Inclusion / Exclusion
4/4
Therapy Description
0/4
Statistics
Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65
Fragility Indexは、重要な所見の解釈を助けるツールで、結果の強さの尺度を提供します。Fragility Indexは、その所見が有意でなくなるために、二項対立の結果に追加する必要がある連続した事象の数を表します。数値が小さいほど弱い所見を表し、数値が大きいほど強い所見を表します。
なぜ今この研究が必要なのですか？
Non-steroidal anti-inflammatory drugs can be used preoperatively and postoperatively as an analgesic, but its use is often discontinued prior to surgical treatment due to the belief that it increases perioperative blood loss. COX-2 inhibitors, a form of non-steroidal anti-inflammatory drug (NSAID), can be used for pain management, but there is uncertainty on its positive and negative effects. This study examines the effect of Celecoxib, a COX-2 inhibitor on perioperative and postoperative outcomes (blood loss, pain, analgesic requirement, range of motion and other subjective outcomes) in total knee replacement (TKR).
主な研究課題は何ですか？
What are the clinical and subjective perioperative and postoperative outcomes of Celecoxib (a COX-2 inhibitor) in patients undergoing total knee replacement (TKR) surgery?
重要な知見は？
- There were no significant differences seen in total, drainage or hidden blood loss between the intervention (Celecoxib) and placebo group. The total blood loss for the placebo group was 810 mL compared to 733 mL for the Celecoxib group. (95%CI= -1.6-11.6)
- The intervention group reported 30% lower pain scores compared to the placebo group during the first 4 weeks postoperatively.
- The intervention group also reported lower opioid consumption postoperatively (6 SD 6 mg vs. 10 SD 7 mg; 95% CI -9.5 to -2.5).
- At the 1-year follow-up, no effect was seen on range of motion, pain, and subjective outcomes.
- No deep infections or wound complications were seen during the first year postoperatively, but one patient from the placebo group sustained a bilateral deep vein thrombosis at 1 month postoperatively. The patient was treated successfully with warfarin.
- KOOS values improved from preoperation measurements in both groups at 3 and 12 months, but the difference between groups was not significant
最も覚えておくべきことは？
The use of Celecoxib did not induce increased blood loss perioperatively, but reduced postoperative pain after total knee replacement (TKR) surgery. At the one-year follow-up, pain, range of motion and subjective outcomes (KOOS score) did not improve following the postoperative use of Celecoxib.
それが私の患者ケアにどのように影響するか？
Patients undergoing total knee replacement (TKR) may find short-term pain relief postoperatively when taking Celecoxib. However, significant results/improvements may not be seen at 1 year. Further studies are being performed by the authors to examine the effect of Celecoxib on early prosthesis fixation.
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