Obturator and Femoral Nerve Block in Patients With Hip Fracture
Analgesic Effect of an Obturator Nerve Block Combined With a Femoral Nerve Block Compared With Femoral Nerve Block Alone in Patients With Hip Fracture
A higher number than expected of patients with hip fracture have only insufficient analgesic effect of a femoral nerve block, which is the nerve block commonly used for this group of patients. One of the possible causes of this failure to provide analgesia from a single nerve block could be the that other nerves are involved in transmitting the pain signal. One of the nerves that is believed to give off branches to the hip is the obturator nerve.
With ultrasound it is possible to make a selective proximal nerve block of the obturator nerve.
The aim of this trial is to test the analgesic effect of a femoral nerve block i combination with an obturator nerve block compared to femoral nerve block alone in a randomized and placebo controlled design.
調査の概要
詳細な説明
A higher number than expected of all patients with hip fracture have only insufficient analgesic effect of a femoral nerve block. One of the possible causes of this failure to provide analgesia from a single nerve block could be the that other nerves are involved in transmitting the pain signal. One of the nerves that is believed to give off branches to the hip is the obturator nerve. Earlier it was believed that the so called '3-in-1-block' or the iliac fascia compartment block would anesthetize also the obturator nerve, and these two nerve blocks have been uses extensively in the emergency ward for preoperative analgesia. Today that is not believed to be true and consequently is the part of the obturator nerve in patients with hip fracture unknown.
With ultrasound it is possible to make a selective proximal nerve block of the obturator nerve before it branches into an anterior and a posterior branch. A selective nerve block of the obturator nerve to access its effect in patients with hip fracture has to our knowledge never been done.
The aim of this trial is to test the analgesic effect of a femoral nerve block i combination with an obturator nerve block compared to femoral nerve block alone in a randomized and placebo controlled design.
研究の種類
入学 (予想される)
段階
- フェーズ 4
連絡先と場所
研究場所
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-
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Aarhus、デンマーク、8000
- 募集
- Aarhus University Hospital
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コンタクト：
- Thomas D. Nielsen, MD
- 電話番号：+45 28782877
- メール：thomas.dahl.nielsen@clin.au.dk
-
コンタクト：
- Thomas F. Bendtsen, MD, Ph.d.
- 電話番号：+45 51542997
- メール：tfb@dadlnet.dk
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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:
- Clinical suspicion of hip fracture
- Age ≥ 55 years
- Mentally capable of comprehending and using verbal pain score
- Mentally capable of differentiating between pain from the fractured hip and pain from other locations
- Mentally capable of understanding the given information
- Arrival in the emergency room at times when one of the doctors who do the nerve blocks for this investigation are on call
- Verbal numeric pain scale score (NRS 0-10) > 5 with a dynamic test OR NRS > 3 at rest
- Patients informed consent
Exclusion Criteria:
- Hip fracture not confirmed by x-ray
- Weight < 40 kg
- Patient has previously been included in this trial
- If the patient wishes to be excluded
- Allergy to local anesthetics or adrenocortical hormone
- Visible infection in the area of the point of needle injection
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：4倍
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：Bupivacaine
Obturator nerve block
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Obturator nerve block
他の名前：
|
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プラセボコンパレーター：Saline
Saline is injected as a placebo
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Obturator nerve block with saline(placebo)
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 |
|---|---|---|
|
Success rate of successful analgesia, measured with numeric rating scale(NRS) 0-10 with 0=no pain and 10=worst pain. Successful analgesia = NRS<4 at rest and NRS <6 with passive movement of the fractured leg.
時間枠：30 minutes
|
Success rate of successful analgesia compared between the groups
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30 minutes
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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 |
|---|---|---|
|
Median pain score (NRS 0-10)
時間枠：30 minutes
|
Median pain score 30 minutes after the nerve blocks compared between the groups
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30 minutes
|
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Median change in pain score (NRS 0-10)
時間枠：30 minutes
|
Median change in pain score 30 minutes after the nerve blocks compared between the groups
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30 minutes
|
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Course in pain reduction
時間枠：30 minutes
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Course in pain reduction during the 30 minutes after the nerve blocks
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30 minutes
|
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Time to sufficient analgesia
時間枠：30 minutes
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Time from ended injection until sufficient analgesia
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30 minutes
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Frequency of anesthesia in the skin area of the saphenous nerve
時間枠：30 minutes
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Frequency of anesthesia in the skin area innervated by the saphenous nerve
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30 minutes
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Frequency of anesthesia in the skin area of the anterior cutaneous branches of the femoral nerve
時間枠：30 minutes
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Frequency of anesthesia in the skin area of the anterior cutaneous branches of the femoral nerve
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30 minutes
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Localization of the worst pain before block
時間枠：0 minutes
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Localization of the worst pain before any nerve blocks
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0 minutes
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Localization of the worst pain after block
時間枠：30 minutes
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Localization of the worst pain 30 minutes after the nerve blocks
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30 minutes
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Discomfort during nerve block procedures (score 0-10, 0=no discomfort)
時間枠：5 minutes
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Discomfort during the nerve block procedures compared between procedures
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5 minutes
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Satisfaction (0-10, 0= very unsatisfactory)
時間枠：30 minutes
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Patient satisfaction with the pain treatment
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30 minutes
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Frequency of ultrasound visualization of femoral nerve
時間枠：5 minutes
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Frequency of patients with possible ultrasound visualization af the femoral nerve
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5 minutes
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Frequency of ultrasound visualization of obturator injection site
時間枠：5 minutes
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Frequency of patients with possible ultrasound visualization of the obturator nerve block injection site
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5 minutes
|
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Time spend on femoral nerve block
時間枠：5 minutes
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Time spend on conducting the femoral nerve block
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5 minutes
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Time spend on obturator nerve block
時間枠：5 minutes
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Time spend on conducting the obturator nerve block
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5 minutes
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Total morphine equivalent dose of opioid from the time of nerve block to operation
時間枠：Approximately 24 hours in average
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Total morphine equivalent dose of opioid from the time of nerve block until the time of operation
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Approximately 24 hours in average
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Total morphine equivalent dose of opioid/time from the time of nerve block to operation
時間枠：Approximately 24 hours in average
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Total morphine equivalent dose of opioid/time from the time of nerve block until the time of operation
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Approximately 24 hours in average
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Total morphine equivalent dose of opioid in the first 10 hours after nerve block
時間枠：10 hours
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Total morphine equivalent dose of opioid given in the first 10 hours after nerve block
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10 hours
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Total morphine equivalent dose of opioid/time in the first 10 hours after nerve block
時間枠：10 hours
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Total morphine equivalent dose of opioid/time given in the first 10 hours after nerve block
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10 hours
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協力者と研究者
スポンサー
捜査官
- スタディディレクター：Thomas F. Bendtsen, Ph.d.、Aarhus University Hospital
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
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
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