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UKR: Intra-articular bupivacaine the day after surgery improves pain and satisfaction
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ARTHROPLASTY

Intra-articular local anaesthetic on the day after surgery improves pain and patient satisfaction after Unicompartmental Knee Replacement: a randomised controlled trial

OrthoEvidence Journal (OE Journal) - ACE Report

OE Journal. 2013;1(11):42 Knee. 2012 Aug;19(4):352-5. Epub 2011 Jun 12

44 patients with end stage osteoarthritis, scheduled to undergo uni-compartmental knee replacement (UKR), were randomized to assess the efficacy of a 24 hour post-operative intra-articular local anaesthetic infusion. Patients either received a 20 ml bolus of 0.5% bupivacaine or a 20 ml bolus of saline. Results over the first 48 hours indicated the anaesthetic injection resulted in a significant decrease in pain and in a greater patient satisfaction than controls, between 24 and 48 hours postoperatively.


出版資金提供の詳細 +
資金提供:
Non-Industry funded
スポンサー:
NIHR Biomedical Research Unit into Musculoskeletal Disease, Nuffield Orthopaedic Centre and the University of Oxford
コンフリクト:
Other

バイアスのリスク

9/10

報告基準

16/20

脆弱性指数

N/A

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

2/4

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?

Total knee and uni-compartmental knee replacement procedures are associated with considerable post-operative pain. The use of number of peri-operative analgesic regimes have been demonstrated to be effective in reducing the post-operative pain and decreasing the total time until hospital discharge. While these methods appear to be effective in reducing the immediate post-operative pain, recent findings have indicated that an appreciable number of patients suffer pain during the first postoperative day, as the nerve block and local analgesia wear off. This may lead to an increased time until mobilization and subsequently hospital discharge. Local infiltration analgesia early on the first post-operative day may address this increase in pain and improve patient satisfaction while decreasing the length of hospital stay.

主な研究課題は何ですか?

Does the use of intra-articular analgesia administer on the first post-operative day through a catherter inserted into the knee during the operation result in decreased pain and improved patient satisfaction compared to controls, measured over the first 48 postoperative hours?

研究の特徴 +
人口:
44 patients with end stage osteoarthritis scheduled to undergo uni-compartmental knee replacement
介入:
Group A: Patients received an intra-articular injection of 20ml 0.5% bupivacaine through an intra-articular catherter that was inserted during the operation. (n=22) All patients received multimodal local infiltration analgesia intra-operatively, a short acting femoral nerve block with 20ml 1% prilocaine, and general anaesthesia.
比較:
Group C: patients received an intra-articular injection of 20ml normal saline through an intra-articular catheter that was inserted during the operation. (n=22, one excluded due to conversion to TKR and one for medical complications)
アウトカム:
The primary outcome was post-operative pain, measured using a visual analog scale (VAS). Secondary outcomes included patients satisfaction, using a nominal scale and rescue analgesia required.
方法:
RCT: Double Blind
時間:
48 hours post operative follow-up (measures taken every 6 hours and additional measures taken 30 minutes after the 24 hour injection)

重要な知見は?

  • Over the first post-operative 24 hours, there were no differences in VAS pain scores between the two groups, as well as prior to the injection of the first 24 hours through the intra-articular catheter. (P>0.05)
  • VAS pain scores prior to the 24 hours injection were 6.32 +/- 2.01 in group A and 5.15 +/- 2.31 in group C.
  • Patients in group A had significantly lower VAS pain scores immediately following the injection after the first 24 hours, (1.8 +/- 1.40 vs 6.1 +/- 1.94 (p<0.001)) and 6 hours following the injection, (2.5 +/- 1.82 vs 5.7 +/- 1.92 (p<0.001))
  • Both groups initially reported a high degree of postoperative satisfaction post infiltration. There was a significant difference between the two groups with group A indicating greater satisfaction (p<0.001).
  • Requirement for rescue analgesia was similar between groups over the first 24 hours, following infiltration 75% of the control group required rescue analgesia compared to 22% of the anaesthetic group (p<0.001). The mean opiate requirement was also different with the controls requiring 12.1 +/- 9.39 mg and the anaesthetic group requiring 3.6 +/- 7.27 (p<0.01)
  • There were no complications reported in any group
最も覚えておくべきことは?

The use of an intra-articular injection of bupivacaine 24 hours following uni-compartmental knee replacement produces a significant reduction in postoperative pain during the 24 to 48 hour postoperative period and improves patient satisfaction in comparison controls receiving a saline injection.

それが私の患者ケアにどのように影響するか?

The use of an intra-articular analgesic infiltration 24 hours postoperatively can significantly reduce patient pain and improve satisfaction. For this reason surgeons should consider it as a possible addition to current analgesic regimes. Additional research should be undertaken to determine if this 24 hour post-operative injection produces a reduction in hospitalization time.

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引用方法 ACE Report

OrthoEvidence. UKR: Intra-articular bupivacaine the day after surgery improves pain and satisfaction. OE Journal. 2013;1(11):42. Available from: https://myorthoevidence.com/AceReport/Show/ukr-intra-articular-bupivacaine-the-day-after-surgery-improves-pain-and-satisfaction

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