Assessing the Efficacy of Intravenous Acetaminophen Versus the Oral Formulation for Perioperative Pain Treatment
To compare oral (PO) to intravenous (IV) acetaminophen with postoperative pain scores, and consumptions of opiates, among orthopedic surgery patients undergoing total knee replacement with spinal anesthesia.
Our hypothesis is that IV acetaminophen patients will have improved analgesia, less opioid consumption, a lower percentage of patients rescuing, or a longer time to first rescue with IV acetaminophen. The investigators will compare the efficacies of oral and intravenous acetaminophen for postoperative pain control, and utilization of opiates as rescue agents.
調査の概要
状態
条件
詳細な説明
Intravenous acetaminophen has rapid onset and potent analgesic properties. Recent studies have shown several advantages of using intravenous acetaminophen perioperatively. However, due to its relatively high cost and limited clinical data concerning its efficacy compared with other agents, physicians are hesitant to use intravenous acetaminophen in the perioperative period.
174 adult patients from the orthopedic surgeons undergoing total knee replacement with spinal anesthesia will be enrolled. The study will be double blind, randomized; placebo controlled comparing oral and IV acetaminophen to each other and a control (placebo). At the time patients arrive in the post-anesthesia care unit (PACU), Group 1 will receive IV 1 gram acetaminophen, and PO placebo; Group 2 will receive PO 1 gram acetaminophen and IV placebo; Group 3 will receive IV placebo and PO placebo.
The primary outcome that will be assessed is pain scores, which will be recorded by using the numeric rating scale 1-10 every 15 minutes. Secondary outcomes include time to rescue analgesia (measured in minutes), time to PACU discharge (measured in minutes), and the total amount of hydromorphone (PO or IV) consumed within 6 hours postoperatively for adequate analgesia (total measured in milligrams) will be collected.
The difference in pain scores will be assessed by a chi-square test. A multivariable regression model will be performed with the clinical and statistically significant variables to remove confounding.
研究の種類
入学 (予想される)
連絡先と場所
研究連絡先
- 名前:Jingping Wang, MD, Ph.D.
- 電話番号:6176432729
- メール:jwang23@partners.org
研究場所
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Massachusetts
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Boston、Massachusetts、アメリカ、02114
- Massachusetts General Hospital
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コンタクト:
- Jingping Wang, MD, Ph.D.
- 電話番号:617-643-2729
- メール:jwang23@partners.org
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主任研究者:
- Jingping Wang, MD, Ph.D.
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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
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Patients undergoing total knee replacement
- Successful spinal placement
- ≥18 years old
Exclusion Criteria:
- Failed spinal anesthesia
- Chronic opiate users
- Liver disease patients
- Allergy/hypersensitivity to acetaminophen
- Patients with baseline dementia
- Patients weighing less than 50kg, history of alcohol dependence, renal impairment, opiate allergy, and pregnancy.
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
- 観測モデル:ケースコントロール
- 時間の展望:見込みのある
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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Pain scores assessed and recorded by using the numeric rating scale
時間枠:Participants will be followed for the duration of their inpatient hosptial stay, an expected average of one week.
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The primary outcome that will be assessed is pain scores, which will be recorded by using the numeric rating scale, from 1-10, every 15 minutes.
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Participants will be followed for the duration of their inpatient hosptial stay, an expected average of one week.
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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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Time to rescue analgesia
時間枠:Participants will be followed for the duration of their hospital stay, an expected average of one week
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The amount of time after the surgery is completed until a patient receives rescue analgesia will be measured in minutes.
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Participants will be followed for the duration of their hospital stay, an expected average of one week
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Time to post-anesthesia care unit (PACU) discharge
時間枠:Participants will be followed for the duration of their PACU stay, an expected average of 5 hours.
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The time from arrive in the PACU to discharge will be measured in minutes.
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Participants will be followed for the duration of their PACU stay, an expected average of 5 hours.
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Opioid Use
時間枠:Participants will be followed for six hours postoperatively.
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The investigators will collect total amount of oral and/ or intravenous hydromorphone that is consumed by for adequate analgesia.
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Participants will be followed for six hours postoperatively.
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Postoperative nausea and vomiting
時間枠:Participants will be followed for six hours postoperatively.
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The investigators will collect information on postoperative nausea and vomiting.
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Participants will be followed for six hours postoperatively.
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協力者と研究者
捜査官
- 主任研究者:Jingping Wang, MD, Ph.D.、Massachusetts General 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 (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
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。
術後の痛みの臨床試験
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Dexa Medica Group完了