GENERAL ORTHOPAEDICS
Local anesthetic wound infiltration for pain management after periacetabular osteotomy. A randomized, placebo-controlled, double-blind clinical trial with 53 patients
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2014;2(13):14 Acta Orthop. 2014 Apr;85(2):141-6Seventy patients scheduled to undergo periacetabular osteotomy were randomized either to receive or not receive local infiltration analgesia (LIA) with ropivacaine intra- and postoperatively. As all patients were treated with opioid based patient-controlled analgesia (PCA) postoperatively, the purpose was to determine whether LIA was effective at reducing the need for PCA (oxycodone) postoperatively. Over the first 4 postoperative days, there was no significant difference between groups in oxycodone 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。
1/4
Randomization
3/4
Outcome Measurements
4/4
Inclusion / Exclusion
4/4
Therapy Description
4/4
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？
Postoperative pain is often considerable following periacetabular osteotomy, requiring analgesia. Current methods of pain management include a psoas block, patient-controlled analgesia (PCA), and continuous epidural and spinal analgesia. While these treatments often lower pain experienced postoperatively, their associated side-effects have prompted researchers to consider alternative methods. Local infiltration analgesia has demonstrated efficacy in total knee and hip arthroplasty procedures, although its role in periacetabular osteotomy has yet to be established.
主な研究課題は何ですか？
What is the efficacy of local infiltration analgesia (LIA) with ropivacaine for postoperative analgesia following periacetabular osteotomy, assessed over the first 4 postoperative days?
重要な知見は？
- There were no significant differences between the LIA and placebo group for oxycodone consumption over the first 4 PODs (POD1 p=0.66; POD2 p=0.86; POD3 p=0.57; POD4 p=0.85).
- VAS pain scores at rest were similar between groups 6h after surgery and on POD 1 (p=0.1 and 0.2, respectively). The LIA group demonstrated significantly lower mean pain scores at rest than the placebo group on POD2 (24 vs. 31), POD3 (19 vs. 31) and POD4 (18 vs. 28) (p<0.05).
- No significant differences in the TUG test or pain after the TUG test were noted between groups for the duration of the 4-day observation period (all p>0.05).
- Antiemetic use was similar between groups for the duration of the placement of the catheter.
最も覚えておくべきことは？
Consumption of patient-controlled analgesia following periacetabular osteotomy was not decreased with the infiltration of ropivacaine at the end of surgery and for 2 days postoperatively.
それが私の患者ケアにどのように影響するか？
From these findings, it would appear that local infiltration of ropivacaine alone is not sufficient to reduce the need for patient-controlled analgesia after periacetabular osteotomy, and that adverse events associated with opioid PCA (postoperative nausea and vomiting) would not be expected to decrease from its implementation. Whether LIA ropivacaine is an efficacious component in mulitmodal analgesia for periacetabular osteotomy remains to be determined in future studies.
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