Paravertebral Catheters for Pancreatic Surgery
Ultrasound Guided Bilateral Paravertebral Catheters Versus Thoracic Epidural Analgesia for Post- Operative Pain Control in Open Pancreatic Surgery: A Prospective Outcomes Study
Design: Level I randomized prospective outcomes study comparing two groups of patients. One group will receive bupivacaine and dilaudid thoracic epidural analgesia (PCA) post-operatively. The other will receive bilateral ultrasound guided paravertebral blocks with indwelling paravertebral catheters with an infusion of 0.2% ropivicaine post-operatively and a PCA.
Sample Size: 50 patients Study Duration: Approximately 12 months Population:. Patients presenting to the University of Minnesota Medical Center for elective open pancreatic surgery.
Primary Objective: To determine if bilateral paravertebral catheters in patients with open pancreatic procedures result in decreased pain compared to patients treated with thoracic epidural for post-operative pain.
Secondary Objectives:
- To determine whether the use of bilateral paravertebral catheters impacts the length of ICU and hospital stay for patients, compared to a thoracic epidurals in patients undergoing elective open pancreatic surgery.
- To determine whether the use of ultrasound guided bilateral paravertebral catheters leads to lower risk of complications, compared to use of a thoracic epidural in patients undergoing open pancreatic surgery.
調査の概要
詳細な説明
Design: Level I randomized prospective outcomes study comparing two groups of patients. One group will receive buipvacanine and dilaudid thoracic epidural analgesia (PCA) post-operatively. The other will receive bilateral ultrasound guided paravertebral blocks with indwelling paravertebral catheters with an infusion of 0.2% ropivicaine post-operatively and a PCA.
Sample Size: 50 patients Study Duration: Approximately 12 months Population:. Patients presenting to the University of Minnesota Medical Center for elective open pancreatic surgery.
Primary Objective: To determine if bilateral paravertebral catheters in patients with open pancreatic procedures result in decreased total maximal pain scores compared to patients treated with thoracic epidural for post-operative pain.
Secondary Objectives:
- To determine whether the use of bilateral paravertebral catheters impacts the length of ICU and hospital stay for patients, compared to a thoracic epidurals in patients undergoing elective open pancreatic surgery.
- To determine whether the use of ultrasound guided bilateral paravertebral catheters leads to lower risk of complications, compared to use of a thoracic epidural in patients undergoing open pancreatic surgery.
2. Synopsis and Medical Application:
Specific Aims:
Primary Hypothesis: Paravertebral catheters will result in improved pain control relative to thoracic epidural for post-operative pain from open pancreatic surgery.
Secondary Hypothesis: Paravertebral catheters will result in fewer hospital days and improved subjective respiratory function compared to patients in the thoracic epidural group.
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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Minnesota
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Minneapolis、Minnesota、アメリカ、55455
- University of Minnesota
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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 undergoing open pancreatic surgery.
Exclusion Criteria:
• Previous difficult airway or multiple previous intubations
- History of myasthenic syndrome
- Systemic infection
- Pre-existing sensory deficit
- PT >14 or PTT >40 sec
- Platelet count less than 50,000
- Creatinine > 1.5
- Allergy to local anesthetics
- Patients who remain intubated for one week after surgery or who are unable to provide information as to their feelings of pain post-operatively for the first week post-operatively
- Use of a spinal or epidural anesthetic for surgery
- Daily use of opioid for more than a week or chronic pain syndrome
- Lack of patient cooperation
Contraindication to regional anesthesia
- Infection at injection site
- Inability to guarantee sterile equipment or sterile conditions for the block
- Patient refusal
- Risk of local anesthetic toxicity
- Coagulopathy or bleeding disorder
- Severe respiratory disease (where the patient depends on intercostal muscle function for ventilation);
- Ipsilateral diaphragmatic paresis;
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：独身
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：Standard of Care
Epidural placed for postoperative pain control
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A mid thoracic epidural is placed preoperatively and a local anesthetic and opioid infusion is run postoperatively
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実験的：Experimental Intervention
Bilateral paravertebral catheters placed for postoperative pain control
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Bilateral paravertebral catheters are placed and a local anesthetic infusion via an elastomeric pump is run postoperatively
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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 |
|---|---|---|
|
total Maximal Pain scored via NRS 0-10 scale
時間枠：on postoperative day 1 through postoperative day 5
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maximal pain scored via NRS 0-10 scale assessed by independent assessor
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on postoperative day 1 through postoperative day 5
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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 |
|---|---|---|
|
Maximal Pain scored via NRS 0-10 scale
時間枠：on postoperative day 1
|
maximal pain scored via NRS 0-10 scale assessed by independent assessor
|
on postoperative day 1
|
|
Maximal Pain scored via NRS 0-10 scale
時間枠：on postoperative day 2
|
maximal pain scored via NRS 0-10 scale assessed by independent assessor
|
on postoperative day 2
|
|
Maximal Pain scored via NRS 0-10 scale
時間枠：on postoperative day 3
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maximal pain scored via NRS 0-10 scale assessed by independent assessor
|
on postoperative day 3
|
|
Maximal Pain scored via NRS 0-10 scale
時間枠：on postoperative day 4
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maximal pain scored via NRS 0-10 scale assessed by independent assessor
|
on postoperative day 4
|
|
Maximal Pain scored via NRS 0-10 scale
時間枠：on postoperative day 5
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maximal pain scored via NRS 0-10 scale assessed by independent assessor
|
on postoperative day 5
|
|
Nausea/vomiting
時間枠：the first five days postoperatively
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the presence of nausea and or vomiting endorsed by the patient as assessed by an independent assessor
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the first five days postoperatively
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Length of stay
時間枠：when the patient meets discharge criteria or is discharged home, expected length of stay 10 days
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up through the time the patient is discharged , expected length of stay 10 days.
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when the patient meets discharge criteria or is discharged home, expected length of stay 10 days
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協力者と研究者
スポンサー
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
急性痛の臨床試験
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