ARTHROPLASTY
High-volume infiltration analgesia in bilateral hip arthroplasty: A randomized, double-blind placebo-controlled trial
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by one or more authors of the
original publication.
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2013;1(2):21 Acta Orthop. 2011 Aug;82(4):423-6. Epub 2011 Jul 1312 patients undergoing bilateral total hip arthroplasty (THA) were randomized to receive a high-volume infiltration of analgesia, administered intraoperatively to one hip, and a placebo saline solution to the other hip. Patients also received a pre-operative oral multimodal analgesic regimen. The primary outcome was postoperative pain. Results indicated that the high-volume analgesic intervention may not produce a clinically relevant analgesic effect post-operatively in patients undergoing bilateral THA compared to the saline group. These results indicate that a pre-operative oral multimodal analgesic regimen may provide sufficient pain relief for THA.
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
3/4
Outcome Measurements
2/4
Inclusion / Exclusion
4/4
Therapy Description
3/4
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？
Local analgesia (intraoperative infiltration) has been reported to be effective in total knee arthroplasty, but there are limited studies and data regarding total hip arthroplasty trials. Postoperative pain after hip arthroplasty may be effectively managed with high-volume analgesia infiltration. Previous studies have examined this hypothesis, but there is uncertainty regarding the results due to methodological limitations. This double-blind placebo-controlled study examines the outcomes with high-volume analgesia infiltration compared to a placebo in bilateral hip arthroplasty.
主な研究課題は何ですか？
What are the outcomes in postoperative pain when patients undergoing bilateral total hip arthroplasty (THA) receive a high-volume infiltration of analgesia (170 mL ropivacaine 0.2% with epinephrine at 1:100,000) with supplementary injections postoperatively, compared to a saline placebo when examined over the course of the first 48 hours postoperatively?
重要な知見は？
- Patients reported similar VAS score for the intervention hip (ropivacaine and epinephrine) and the placebo hip (saline) at rest and at 45 deg hip flexion (p>0.05)
- Significantly less pain was reported in the saline placebo hip at rest, 32 hr postoperatively (p=0.03)
- The median hospital stay between the two groups was 7 days (Range: 2-7 days), and the mean duration of surgery was 178 (range 76-325) minutes.
- At 4, 8, 24, 32, and 48 h postoperatively, patients received a morphine administration of 6.5 (4-12) mg, 14 (11-26) mg, 32 (17-53) mg, 36 (19-61) mg, and 43 (20-70) mg, respectively.
- No complications requiring intervention were reported during the study period.
最も覚えておくべきことは？
Patients in both the intervention (Ropivacaine) and placebo (saline) group had comparably low pain scores. An intraarticular high-volume (170 mL) ropivacaine (0.2%) with epinephrine (1:100,000) treatment, followed by repeated postoperative injections, may not result in clinically effective analgesia effect in patients undergoing total hip arthroplasty, when combined with a multimodal oral analgesia taken pre-operatively.
それが私の患者ケアにどのように影響するか？
Patients receiving a high-volume intraoperative injection of ropivacaine 0.2% perioperatively, followed by repeated postoperative injections, may not find any clinically relevant analgesic effect when treatment is combined with mutimodal oral analgesic regimen taken pre-operatively.
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