IV Acetaminophen for Postoperative Pain Analgesia After Laparoscopic Hysterectomy
Intravenous Acetaminophen Versus Saline in Postoperative Analgesia After Laparoscopic Hysterectomy: A Randomized, Double Blind, Placebo Controlled Trial
調査の概要
詳細な説明
Gynecologic surgery has been revolutionized by the incorporation of minimally invasive techniques. Procedures that once resulted in multiple day hospital admissions are now being performed in outpatient surgery centers. Common factors that contribute to delayed discharge are inadequate postoperative pain control and increased nausea and vomiting. A multi-modal pain management approach is considered optimal at controlling postsurgical pain, which includes combining different analgesics that act in varying mechanisms. By using medications that act synergistically, the overall analgesia requirement can oftentimes be decreased.
Opioids have been found to be highly effective in controlling postoperative pain; however, are associated with dose-dependent risks including nausea, vomiting, constipation, urinary retention, sedation, and respiratory depression. Subsequently, non-opioid options are frequently desired in an attempt to minimize narcotic intake. In the United States, intravenous acetaminophen was approved by the US Food and Drug Administration (FDA) in November 2010 for the management of mild to moderate pain and the reduction of fever. Since this time, multiple studies have analyzed the role of intravenous acetaminophen in both acute and postoperative pain; however, none have been specific to laparoscopic hysterectomy. The primary study published evaluating intravenous acetaminophen in laparoscopic hysterectomies also included multiple other laparoscopic procedures from a variety of specialties including general surgery, urology, and urogynecology. In addition, the intravenous acetaminophen was started on average 19 hours after the conclusion of the case once the patient controlled analgesic was discontinued.
Improved postsurgical pain control achieved with intravenous acetaminophen may potentially lead to same day discharge after major laparoscopic gynecologic procedures. Same day discharge after laparoscopic hysterectomy has been shown to be a safe option with proper patient counseling and multi-modal pain medications. In addition, same day discharge is also associated with decreased health care expenditures. With continued efforts to cut hospital costs, the pressure to discharge patients earlier continues to be high.
The investigators propose that intravenous acetaminophen will improve post-operative pain control and decrease narcotic requirements for patients undergoing laparoscopic hysterectomies. Furthermore, The investigators expect to find decreased postsurgical nausea and vomiting and potentially quicker discharge to home. This could have a large impact on the field of gynecologic surgery as major procedures that once required overnight admission may now succeed at same day discharge.
研究の種類
入学 (実際)
段階
- フェーズ 4
連絡先と場所
研究場所
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Pennsylvania
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Pittsburgh、Pennsylvania、アメリカ、15213
- Magee Womens Hospital
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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:
- Women aged 18-75
- Ability to read and write in English (our post-operative pain log is only available in English)
- Planning a laparoscopic hysterectomy (includes total laparoscopic hysterectomy, laparoscopic supracervical hysterectomy, laparoscopically assisted vaginal hysterectomy, with or without salpingooophorectomy)
Exclusion Criteria:
- Answering yes to any of the following questions: "Do you have a history of liver disease, kidney disease, hepatitis C, history of liver failure, greater than 3 drinks per day or being have you ever been told by your doctor that they should not take acetaminophen"
- History of cardiac arrhythmia
- History of jaundice
- Acute abdominal inflammatory or infectious process at time of surgery
- Known malignancy at time of surgery
- Known pregnancy at time of surgery
- Plan to perform additional significant surgical procedure at the time of hysterectomy such as extensive excision of endometriosis on bowel or bladder or pelvic reconstructive procedure
- >6cm abdominal incision in order to remove the uterus at time of study-related hysterectomy
- Regular use of narcotic pain medication (defined as use on most days of the week at any point in the past 3 months)
- Allergy to acetaminophen
- Women who weigh less than 50 kilograms on the day of surgery.
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：トリプル
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：Intravenous IV acetaminophen
The patients in the treatment arm will receive 1000mg of IV acetaminophen.
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The patients in the treatment arm will receive 1000mg of IV acetaminophen.
他の名前：
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プラセボコンパレーター：Normal Saline
The patients in the placebo arm will receive normal saline.
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The patients in the placebo arm will receive normal saline.
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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Postoperative Pain
時間枠：24 hours
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The primary aim of this study is to compare overall post-surgical pain after hysterectomy as reported by the patients on a visual analog scale with a range of 0 to 10 where 0 is no pain at all and 10 is the worst pain that a person can imagine.
Less pain is considered preferable to more pain.
The theory is that patients who have intravenous acetaminophen will report less post-surgical pain.
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24 hours
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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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Narcotic Medication Use
時間枠：24 hours
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The secondary outcome is comparison of narcotic pain medical requirements within the first 24 hours after surgery.
The hypothesis is that the intravenous acetaminophen group will require less narcotic medications than the placebo group.
Narcotic use in this study will be calculated by converting all narcotics (fentanyl, dilaudid etc) into standardized units of morphine using well validated conversion tables.
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24 hours
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Having a Feeling of General Well-being at One Month
時間枠：4 weeks
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Quality of recovery will be evaluated through the use of the validated Quality of Recovery-40 questionnaire.
The hypothesis is that the intravenous acetaminophen group will experience an increased quality of recovery as compared to the placebo group.
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4 weeks
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Number of Participants Who Vomited Within 24 Hours of Operation
時間枠：24 hours
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A secondary aim of this study is to compare post-operative vomiting scores on post-operative day zero and one.
Vomiting is reported as either having vomited or not vomited.
The hypothesis is that the intravenous acetaminophen group will experience decreased vomiting compared with the placebo group.
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24 hours
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Readiness for Discharge
時間枠：24 hours
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Patient perception of satisfaction at time of discharge on post-operative day zero will be evaluated.
The hypothesis is that intravenous acetaminophen group will experience increased satisfaction for discharge than the placebo group.
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24 hours
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Nausea Before Surgery as Compared to After Surgery
時間枠：24 hours
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A secondary aim of this study is to compare post-operative nausea on post-operative day zero and one as reported by the patients on a visual analog scale with a range of 0 to 10 where 0 is no nausea at all and 10 is the worst nausea that a person can imagine.
Less nausea is considered preferable to more nausea.
The hypothesis is that the intravenous acetaminophen group will experience decreased nausea compared with the placebo group.
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24 hours
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Noah Rindos, MD、Faculty
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 (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。
痛みの臨床試験
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Bingol UniversityAtaturk Universityまだ募集していません術前不安 | 恐れ | PAİN
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Dexa Medica Group完了
IV acetaminophenの臨床試験
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Sir Run Run Shaw Hospitalまだ募集していません
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