Saphenous Nerve Block: Single Shot Versus Continuous Infusion to Supplement a Continuous Sciatic Nerve Block After Major Ankle Surgery
A Randomized Comparison of Single Injection vs. Continuous Saphenous Nerve Block to Supplement a Continuous Sciatic Nerve Block in Postoperative Pain Treatment After Major Ankle Surgery: Clinical Outcome and Cost Analysis
The most useful method to manage pain after major ankle surgery is infusion of local analgesics with a catheter close to the sciatic nerve.
Sensation from the ankle are carried by three nerves: The tibial and peroneal nerve (unified in the sciatic nerve) and the saphenous nerve.
Study purpose is to test whether continuous infusion of local analgesics by saphenous nerve catheter provide a better treatment of pain in comparison with a single injection nerve block. In addition cost-effectiveness of the two methods are compared.
The 50 patients of the trial are randomized in clusters of ten. We intend to do a preliminary analysis of the data from the first 40 patients. However, it is not an interim analysis. Fifty patients will be included independent of the result of the preliminary analysis. The random allocation of the last 10 patients will also be double-blinded.
調査の概要
詳細な説明
Major ankle surgery are known to be very painful the first 48 hours after the operation due to surgical oedema. This pain is difficult to control with systemic analgesics. Pain relief with systemic analgesics requires high doses of intravenous opioids and is associated with breakthrough pain and adverse effects of opioids (sedation, nausea, vomiting, obstipation, urinary retention, respiratory depression).
Continuous, peripheral nerve block with catheter technique for two days minimizes the need for systemic analgesics. Today such a continuous sciatic nerve block is part of the standard pain treatment after major ankle surgery on Aarhus University Hospital. Despite accurate placement of the catheter many patients are in great pain because the saphenous nerve remain unaffected. A single injection block relieve the pain but a block with Ropivacaine only last 8-15 hours.
Severe postoperative pain leads to high opioid dosages, cognitive blurring, nausea, vomiting, reduced ambulation, increased surgical stress response and increased morbidity. Pain problems and adverse effects prolongs postoperative observation time and maybe also time to discharge.
The aim of the study establish whether continuous saphenous nerve block is efficient (pain relief or reduced opioid consumption) and justified (cost-effectiveness analysis) compared with single injection block.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Aarhus、デンマーク、8000
- Aarhus University Hospital
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria: Elective major ankle surgery
- total ankle arthroplasty
- subtalar fusion
- ankle fusion (non arthroscopic)
Exclusion Criteria:
- coagulation abnormalities
- infection in the region of needle insertion
- systemic infection
- preoperative consumption of high dose opioid
- preoperative sciatic or femoral nerve neuropathy
- preoperative sensory deficit in either of the lower extremities
- Charcot-Marie-Tooth disorder
- diabetic neuropathy
- severe peripheral vascular disease
- allergy to local anesthetics
- lack of understanding of Numeric Rank Scale (NRS)
- communication problems
- dementia
- body mass index above 35
- bilateral continuous sciatic nerve block
- lack of consent
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：0,2% Ropivacaine
Patients randomized to the experimental group receive a continuous infusion of 0,2 % Ropivacaine by elastomeric infusion pump at 5 ml/h in the saphenous catheter after major ankle surgery. Infusion for 48 postoperative hours. All patients receive a preoperative single shot of Ropivacaine around saphenous and sciatic nerve and a postoperative continuous sciatic nerve block. |
0,2% Ropivacaine by elastomeric infusion pump at 5 ml/h for 48 postoperative hours
他の名前：
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プラセボコンパレーター：Control
Patients randomized to the control group receive a continuous infusion of isoton saline by elastomeric infusion pump at 5 ml/h in their catheter after major ankle surgery. Infusion for 48 postoperative hours. All patients receive a preoperative single shot of Ropivacaine around saphenous and sciatic nerve and a postoperative continuous sciatic nerve block. |
Isoton saline by elastomeric infusion pump at 5 ml/h for 48 postoperative hours
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
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Accumulated opioid consumption
時間枠：First 48 hours postoperative
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First 48 hours postoperative
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Success rate for saphenous nerve analgesia
時間枠：Postoperative, first 48 hours
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Pain rated by NRS and opioid consumption
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Postoperative, first 48 hours
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Success rate for clinical analgesia of foot and ankle
時間枠：Postoperative, first 48 hours
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Pain rated by NRS and opioid consumption
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Postoperative, first 48 hours
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Success rate for tibial and peroneal nerve block
時間枠：Postoperative, first 48 hours
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Pain rated by NRS and test of sensation on the toes
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Postoperative, first 48 hours
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Localisation of worst pain
時間枠：Postoperative, first 48 hours
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Postoperative, first 48 hours
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Cost-effectiveness
時間枠：2 first postoperative days
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2 first postoperative days
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Thomas F Bendtsen, ph.d., MD、Aarhus University Hospital
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 2011-0184
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