Efficacy of Fascia Iliaca Block Versus Intraoperative Nerve Infiltration During Anterior Hip Replacement Surgery
調査の概要
詳細な説明
Though still uncommonly used in the United States, the popularity of the anterior approach for total hip replacement is rapidly growing because of its clinical advantages. Rehabilitation is simplified and accelerated, dislocation risk is reduced, leg length is more accurately controlled, and incision is smaller than with traditional approaches (GOEBEL). Nevertheless, although pain is lessened, it is still considerable, and new techniques have been developed to improve postoperative pain control for this procedure.
Surgical incision and tissue trauma result in postoperative pain. Regional pain blocks, especially when done under ultrasound guidance, have proven to be extremely effective at reducing postoperative pain and improving patient satisfaction. One such block, the fascia iliaca compartment block (FICB), has been shown to be effective in controlling pain associated with surgery involving the hip and femur.
Although possible without ultrasound guidance, using this technique allows for identification of specific tissue planes and precise placement of medication near the nerves responsible for postoperative pain. Using ultrasound, the superficial fascial layer of the iliopsoas muscle is identified at the anterior edge of the ilium, and a needle is placed just beneath that fascia. A high volume of local anesthetic is then injected under ultrasound guidance, ensuring cephalad spread of medication, in an attempt to provide anesthesia of the lateral femoral cutaneous, femoral and obturator nerves.
Unlike other approaches to hip replacement, anterior repair allows for direct visualization of the fascial layers described above. This allows for direct injection of local anesthetic beneath this fascia, potentially obviating the need for preoperatively performed, ultrasound guided, FICB. The primary differences in approach (ultrasound guided preop versus direct visualization intraop) is the timing of injection, and it is unclear if nerve block prior to or after tissue damage affects postoperative pain in these patients.
Surgical trauma causes nerve sensitization leading to amplification and prolongation of postoperative pain. In experimental studies, pre-injury neural blockade using local anesthetics has been shown to reduce post-injury sensitization of the central nervous system, while similar techniques applied after the injury had less or no effect (FILOS). Investigators have therefore designed this study to examine the timing of FICB (pre-operatively versus intra-operatively) on postoperative pain in patients undergoing anterior hip replacement surgery.
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
-
-
Michigan
-
Royal Oak、Michigan、アメリカ、48073
- Beaumont Health System
-
-
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:
- Adults 18-65 years of age
- Female patients must be surgically sterile, postmenopausal or have a negative pregnancy test on the day of surgery
- Willing and able to sign the informed consent approved by the Institutional Review Board (IRB)
- Willing and able to complete the study procedures and pain scales, and to communicate meaningfully in English with study personnel
- Elective anterior hip replacement to be performed at Beaumont Hospital, Royal Oak
- American Society of Anesthesiologists physical status classification 1, 2, and 3 (patients that have either no systemic illness, or mild to moderate systemic disease, eg. asthma, diabetes or hypertension)
Exclusion Criteria:
- History of allergy to study medications including ropivacaine and other local anesthetic agents of the amide-type
- Enrollment in concurrent research study
- Female patients who are pregnant or lactating, or who have a positive urine pregnancy test
- Opioid tolerant, ie, A patient taking a narcotic > 30mg per day morphine equivalent. (Source: www.globalrph.com/narcotic.cgi) for pain in the 2 months prior to surgery
- A medical condition that in the investigator's opinion could adversely impact the patient's participation or safety, conducts of the study, or interferes with the pain assessments
- Previous hip arthroplasty (partial or total) of the index hip
- History of illicit drug use, or prescription medicine or alcohol abuse within the past 2 years
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：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Pre-operative Ultrasound FICB Group
Enrolled subjects will receive FICB with 50cc of 0.3% ropivacaine.
Blocks will be performed under an ultrasound guidance device with an in-plane technique by a single study investigator, in the preoperative area.
|
Enrolled subjects will receive FICB with 50cc of 0.3% ropivacaine.
Blocks will be performed under ultrasound guidance with an in-plane technique by a single study investigator in the preoperative area.
Although possible without ultrasound guidance, using this technique allows for identification of specific tissue planes and precise placement of medication near the nerves responsible for postoperative pain.
Using ultrasound, the superficial fascial layer of the iliopsoas muscle is identified at the anterior edge of the ilium, and a needle is placed just beneath that fascia.
A high volume of local anesthetic is then injected under ultrasound guidance, ensuring cephalad spread of medication in an attempt to provide anesthesia of the lateral femoral cutaneous, femoral and obturator nerves.
|
|
アクティブコンパレータ：Intra-operative FICB Group
Enrolled subjects will receive FICB with 50cc of 0.3% ropivacaine.
Blocks will be performed intra-operatively under direct surgeon visualization, in the operating room.
|
Enrolled subjects will receive FICB with 50cc of 0.3% ropivacaine.
Blocks will be performed intra-operatively under direct surgeon visualization, in the operating room.
Unlike other approaches to hip replacement, anterior repair allows for direct visualization of the fascial layers described above.
This allows for direct injection of local anesthetic beneath this fascia, potentially obviating the need for preoperatively performed, ultrasound guided, FICB.
|
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 |
|---|---|---|
|
Postoperative Pain During PACU Admission
時間枠：From time of PACU admission until discharge from PACU, an average of 2 hours
|
Pain assessments will be made by the subject using a 10.0 cm Visual-Analog scale (VAS) (scale 1-100 where 1=minimal pain and 100= worst pain imaginable) as follows at each time point:
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From time of PACU admission until discharge from PACU, an average of 2 hours
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Postoperative Pain During Recovery
時間枠：From discharge from PACU until discharge from hospital, an average of 2-3 days
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Pain assessments were made by the subject using a 10.0 cm VAS (scale 1-100 where 1=minimal pain and 100= worst pain imaginable) prior to any request for pain medication.
Up to 40 values per patient were averaged.
|
From discharge from PACU until discharge from hospital, an average of 2-3 days
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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 |
|---|---|---|
|
Incidence of Adverse Events
時間枠：From the signature on the informed consent document for the duration of the hospital stay, an expected average of 2 - 3 days.
|
Measure is count of participants experiencing any adverse event.
Adverse events will be reported by the patient (or when appropriate, staff personnel) during hospitalization.
|
From the signature on the informed consent document for the duration of the hospital stay, an expected average of 2 - 3 days.
|
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Patient Satisfaction With Postoperative Pain Control
時間枠：At the 3 week post-op visit
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Patient satisfaction with postoperative pain control, using a 10 point Likert scale where 1=extremely dissatisfied and 10= extremely satisfied.
Patients were called 3 weeks post-op to determine pain control satisfaction.
|
At the 3 week post-op visit
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Randy Fayne, DO、Beaumont Health System
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
- 2011-285
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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