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Addition of low-dose morphine to spinal anaesthesia improves analgesia with cFNB in TKA
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ARTHROPLASTY

Comparison of continuous femoral nerve block (CFNB/SA) and continuous femoral nerve block with mini-dose spinal morphine (CFNB/SAMO) for postoperative analgesia after total knee arthroplasty (TKA): a randomized controlled study
Verified
This report has been verified by one or more authors of the original publication.

OrthoEvidence Journal (OE Journal) - ACE Report

OE Journal. 2016;4(20):3 BMC Anesthesiol. 2016 Jul 16;16(1):38

70 patients scheduled for total knee arthroplasty under spinal anesthesia and a continuous femoral nerve block were randomized to spinal anesthesia with or without the addition of mini-dose morphine (0.035mg). The purpose of this study was to evaluate if there was any significant difference between groups in pain scores and opioid consumption. Patients were monitored up to 48 hours postoperatively. Results demonstrated significantly lower pain scores and tramadol consumption in the group which received mini-dose spinal morphine. The incidence of postoperative nausea and vomiting was significantly greater within the first 6 hours in the group administered the mini-dose spinal morphine.


出版資金提供の詳細 +
資金提供:
Non-Industry funded
スポンサー:
Faculty of Medicine Ramathibodi Hospital, Mahidol University
コンフリクト:
None disclosed

バイアスのリスク

7/10

報告基準

14/20

脆弱性指数

1

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。

2/4

Randomização

3/4

Medidas de resultado

1/4

Inclusão/Exclusão

4/4

Descrição do tratamento

4/4

Estatística

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?

Severe knee pain following total knee arthroplasty is not uncommon and can delay physical therapy and recovery. Femoral nerve blocks are often used for postoperative analgesia after TKA, though mixed results regarding its efficacy have been reported. To improve the efficacy of a postoperative analgesia protocol involving FNB, use of mini-dose spinal morphine has been suggested as a possible supplementary method.

主な研究課題は何ですか?

In total knee arthroplasty with a continuous femoral nerve block, is there any significant difference in postoperative analgesia efficacy between spinal anesthesia with and without the addition of mini-dose morphine, assessed over 48 hours postoperatively?

研究の特徴 +
人口:
70 patients, 40-80 years of age, scheduled for primary unilateral total knee arthroplasty. All patients received a femoral nerve block, under nerve stimulation guidance, with 20mL 0.25% levobupivacaine, followed by continuous infusion of 0.125% levobupivacaine at 7mL per hour (down to 5mL/hour at VAS < 3) for 48 hours. Tramadol 50mg IV was administered for breakthrough pain (VAS > 4).
介入:
Mini-dose morphine group: Patients received spinal anaesthesia with 2.8mL levobupivacaine and morphine 0.035mg. (n=35; 35 analyzed) (Mean age: 69.60+/-7.39)
比較:
Control group: Patients received spinal anesthesia with 2.8mL levobupivacaine only. (n=35; 33 analyzed) (Mean age: 68.09+/-8.37)
アウトカム:
The pain was assessed using a visual analog scale, and the incidence of severe postoperative pain (VAS 4-7) was documented. Cumulative tramadol consumption was also recorded. Adverse events were documented.
方法:
RCT; Assessor blind
時間:
Patients were assessed at 1, 6, 12, 24, 36, and 48 hours postoperatively.

重要な知見は?

  • Significant differences in median VAS pain scores were observed between groups, being significantly lower in the mini-dose morphine group compared to the control group at 12 hours (3 [0-7] vs. 6 [0-10]; p<0.01), 24 hours (3 [0-7] vs. 5 [0-10]; p<0.01), and 48 hours postoperatively (3 [0-7] vs. 4 [0-10]; p=0.03).
  • Groups also demonstrated a significant difference in the incidence of severe postoperative pain, being significantly lower in the mini-dose morphine group compared to the control group at 12 hours (15/35 vs. 23/33; p=0.03), 24 hours (16/35 vs. 22/33; p=0.03), and 48 hours (9/35 vs. 17/33; p=0.03).
  • Cumulative tramadol consumption over the first 48 hours postoperative was significantly lower in the mini-dose morphine group (125mg [50-400]) compared to the control group (200mg [50-500mg]) (p=0.01).
  • The incidence of postoperative nausea and vomiting (PONV) was significantly greater in the mini-dose morphine group (40%) compared to the control group (15%) at 6 hours postoperatively (p=0.05); differences between groups at 1, 12, 24, 36, and 48 hours postoperatively were not significant.
最も覚えておくべきことは?

In total knee arthroplasty, the addition of morphine 0.035mg to spinal anaesthesia with levobupivacaine, in combination with standardized continuous femoral nerve block, demonstrated significantly lower pain scores and incidences of severe pain within the first 48 hours postoperatively when compared to spinal anaesthesia without morphine, but also increased the incidence of PONV at 6 hours postoperatively.

それが私の患者ケアにどのように影響するか?

The results of this study suggest that the addition of low-dose morphine to spinal anesthesia may offer improved short-term analgesic efficacy of a multimodal regimen with continuous femoral nerve block in patients undergoing total knee arthroplasty. Nonetheless, even the low dose used in the current study was observed to increase the rate of postoperative nausea and vomiting to a significant degree. As such, there is a need for further study methods of potentially limiting the impact of the morphine-related side effects on patient outcome, or whether an even lower dose of morphine can demonstrate the same analgesic efficacy observed in this trial while avoiding an increase in the incidence of PONV.

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引用方法 ACE Report

OrthoEvidence. Addition of low-dose morphine to spinal anaesthesia improves analgesia with cFNB in TKA. OE Journal. 2016;4(20):3. Available from: https://myorthoevidence.com/AceReport/Show/addition-of-low-dose-morphine-to-spinal-anaesthesia-improves-analgesia-with-cfnb-in-tka

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