Saphenous Nerve Block Versus Femoral Nerve Block for Total Knee Arthroplasty
Saphenous (Adductor Canal) Nerve Block Versus Femoral Nerve Block for Total Knee Arthroplasty: A Novel Approach for Postoperative Analgesia
Currently, the regional anesthetic standard of care for total knee replacement surgery is combined spinal/epidural, with or without a femoral nerve block, or FNB. Lasting approximately 18 hours, the FNB works by numbing the femoral nerve (and its branches), which is the major nerve controlling the knee joint. The femoral nerve also provides movement and sensation. While this regional anesthetic technique offers significant postoperative pain relief, it is possible that it may cause muscle weakness and increase patients' recovery time. Hence there is a need for an alternative technique, one that may help minimize postoperative pain as effectively as the FNB, while not causing weakness of the quadriceps muscle.
The saphenous nerve, a branch of the femoral nerve, provides sensation to the knee. Thus it is hypothesized that by "blocking" or anesthetizing the saphenous nerve with local anesthetic closer to where it branches off, the area around and below the knee will feel numb. Yet unlike with the FNB, the quadriceps muscle itself will still be able to function.
Patients will be randomized to receive FNB or saphenous nerve block. Quadriceps strength will be tested using a dynamometer before surgery (baseline), 6-8 hours following anesthesia administration, and on postoperative days 1 and 2. It is hypothesized that patients who receive FNB will experience a 50% decrease in quadriceps strength compared to baseline.
調査の概要
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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New York
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New York、New York、アメリカ、10021
- Hospital for Special Surgery
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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:
- All patients ages 18-90 undergoing primary unilateral total knee arthroplasty
- Planned use of neuraxial anesthesia
- Ability to follow study protocol
- American Society of Anesthesiology (ASA) Class 1-3
Exclusion Criteria:
- Contraindication to a spinal or epidural anesthetic
- Chronic opioid use (defined as daily or almost daily use of opioids for >3 months)
- Hypersensitivity and/or allergy to local anesthetics
- Intraoperative use of any volatile anesthetic
- Patients with a pre-existing neuropathy on the operative limb
- Contraindication to a femoral nerve block or saphenous nerve block
- Allergy to any of the study medications
- Non-English speaking patients
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:ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的:Experimental
Saphenous (Adductor Canal) Nerve Block
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The study group will receive the saphenous nerve block, at the level of the adductor canal.
The block will be under ultrasound guidance.
The local anesthetic will be 15 ml of 0.5% bupivicaine.
The study group will also receive a combined spinal epidural, with 2.5 ml of 0.5% bupivacaine as the spinal agent.
Additional drugs include anti-emetics, specifically Ondansetron (4 mg).
他の名前:
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アクティブコンパレータ:Control
Femoral Nerve Block
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The control group will receive the femoral nerve block.
The block will be under ultrasound guidance.
The local anesthetic will be 30 ml of 0.25% bupivicaine.
The control group will also receive a combined spinal epidural, with 2.5 ml of 0.5% bupivacaine as the spinal agent.
Additional drugs include anti-emetics, specifically Ondansetron (4 mg).
他の名前:
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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 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Quadriceps Muscle Strength
時間枠:48 hours following administration of anesthesia.
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Measurements were made by a handheld dynamometer while patients perform isometric exercises.
Results are presented in kilogram-force (kgF) units.
One kgF is equal to 9.80665 N.
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48 hours following administration of anesthesia.
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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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Total Opioid Usage
時間枠:Postoperative day 4.
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Opioid consumption data were collected and converted to oral morphine equivalents.
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Postoperative day 4.
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NRS Pain Scores at Rest
時間枠:Postoperative day 4.
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Patients rated pain on a scale of 0-10, with 0 representing no pain and 10 representing worst pain.
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Postoperative day 4.
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Patient Satisfaction With the Nerve Block.
時間枠:24 hours following administration of anesthesia.
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Patient satisfaction was measured on a 0-10 scale (0=not satisfied; 10=very satisfied).
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24 hours following administration of anesthesia.
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Incidence of Postoperative Complications.
時間枠:Postoperative day 4.
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Postoperative day 4.
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Total Length of Hospital Stay
時間枠:Total length of hospital stay
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Total length of hospital stay
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協力者と研究者
捜査官
- 主任研究者:David H. Kim, MD、Hospital for Special Surgery, New York
出版物と役立つリンク
一般刊行物
- Akkaya T, Ersan O, Ozkan D, Sahiner Y, Akin M, Gumus H, Ates Y. Saphenous nerve block is an effective regional technique for post-menisectomy pain. Knee Surg Sports Traumatol Arthrosc. 2008 Sep;16(9):855-8. doi: 10.1007/s00167-008-0572-4. Epub 2008 Jun 24.
- Capdevila X, Barthelet Y, Biboulet P, Ryckwaert Y, Rubenovitch J, d'Athis F. Effects of perioperative analgesic technique on the surgical outcome and duration of rehabilitation after major knee surgery. Anesthesiology. 1999 Jul;91(1):8-15. doi: 10.1097/00000542-199907000-00006.
- Bohannon RW. Measuring knee extensor muscle strength. Am J Phys Med Rehabil. 2001 Jan;80(1):13-8. doi: 10.1097/00002060-200101000-00004.
- Singelyn FJ, Deyaert M, Joris D, Pendeville E, Gouverneur JM. Effects of intravenous patient-controlled analgesia with morphine, continuous epidural analgesia, and continuous three-in-one block on postoperative pain and knee rehabilitation after unilateral total knee arthroplasty. Anesth Analg. 1998 Jul;87(1):88-92. doi: 10.1097/00000539-199807000-00019.
- Horn JL, Pitsch T, Salinas F, Benninger B. Anatomic basis to the ultrasound-guided approach for saphenous nerve blockade. Reg Anesth Pain Med. 2009 Sep-Oct;34(5):486-9. doi: 10.1097/AAP.0b013e3181ae11af.
- Kandasami M, Kinninmonth AW, Sarungi M, Baines J, Scott NB. Femoral nerve block for total knee replacement - a word of caution. Knee. 2009 Mar;16(2):98-100. doi: 10.1016/j.knee.2008.10.007. Epub 2008 Nov 28.
- Maffiuletti NA. Assessment of hip and knee muscle function in orthopaedic practice and research. J Bone Joint Surg Am. 2010 Jan;92(1):220-9. doi: 10.2106/JBJS.I.00305.
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 (実際)
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
- 2012-031
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