Efficacy of IV Acetaminophen for Pain Management
2019年1月2日 更新者：Aultman Health Foundation
Efficacy of IV Acetaminophen for Pain Management Following Major Gynecologic Surgery: Effect on Opioid Rescue, Return of Bowel Function, Cost and Length of Hospital Stay.
The investigators' goal in this planned prospective, randomized, patient blinded study is to compare our standard of care as the control group to an experimental group in which patients receive preemptive IV acetaminophen dosing that is continued every 6 hours for a total of 8 doses in patients who have undergone major gynecologic surgery.
The outcomes analyzed will include amount of rescue opioids required, time to return of bowel function, length of hospital stay, and patient satisfaction.
The hypothesis is that the addition of IV acetaminophen will decrease the need for opioid rescue and thereby decrease the incidence of associated gastrointestinal side effects including nausea, vomiting, bloating, and constipation.
The hope is that it will affect the final outcome of quicker return of bowel function, increased patient satisfaction, shortened hospital stay and prove to be an overall more effective postoperative pain management approach.
調査の概要
詳細な説明
This is a patient-blinded prospective study in which patients that undergo major gynecologic surgery via an open abdominal approach will be randomized into two arms:
- Control Group: Morphine patient-controlled-anesthesia (PCA) for the initial 24 hours post-operation with a low-dose basal rate (0.5mg/hr) and patient administered boluses prn. Oral oxycodone from 24-48 hours post-operation will be used prn for pain and then patients will be transitioned to oral combined oxycodone/acetaminophen for the remainder of their hospital stay. Normal saline 100cc IV will be infused as placebo every 6 hours for a total of eight doses with the first dose being given at time of anesthesia induction.
- Experimental Group: Morphine PCA for the initial 24 hours post-operation with low-dose basal rate (0.5mg/hr) with patient administered boluses prn. IV acetaminophen 1,000mg will be given every six hours for a total of eight doses with the first dose being given at time of anesthesia induction. Oral oxycodone from 24-48 hours post-operation will be used prn and then patients will be transitioned to oral combined oxycodone/acetaminophen for the remainder of their hospital stay.
Outcomes that will be analyzed include the amount of opioids used; time to return of bowel function designated as passage of flatus; time to first bowel movement if it occurs while inpatient; duration of hospital stay; and patient symptoms and satisfaction at the 24 and 48 hour marks as well as at time of discharge.
研究の種類
介入
入学 (実際)
68
段階
- フェーズ 4
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Ohio
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Canton、Ohio、アメリカ、44720
- Aultman Health Foundation
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～85年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
女性
説明
Inclusion Criteria:
-Female patients undergoing major gynecologic surgery via an open abdominal approach. The included surgeries would be exploratory laparotomy with or without removal of uterus, fallopian tubes, or ovaries.
Exclusion Criteria:
- Patients with baseline preoperative liver function enzymes (AST and ALT) that are greater than twice the upper limit of normal would be excluded.
- Patients with baseline CrCl <30.
- Patients that require intensive postoperative care and delayed extubation will typically require additional sedation which would impede adequate evaluation of the two study pain regimens as they are designed to be patient controlled.
- Patients with complications unrelated to the pain regimens that prolong their stay would be excluded from the evaluation of hospital stay and cost effectiveness analyses. Examples would include but are not limited to pre-renal azotemia and acute renal failure; pneumonia; venous thromboembolism; or need for re-exploration laparotomy.
- Allergy to acetaminophen would exclude those patients set to enter the experimental IV acetaminophen study arm. One exception would be if the allergy were trivial and related to route of administration such as mild nausea with oral acetaminophen.
- Patients that undergo a bowel resection during surgery as it may adversely effect return of bowel function
- Patients that have required regular opioid intake for the 7 days preceding surgery.
- NSAIDs within 8 hours of surgery.
- Chronic steroid use with the exception of low-dose inhaled steroid formulations.
- Chronic alcohol or drug abuse.
- Patients currently pregnant.
- Patients unable to provide informed consent.
- Age >85
- Any physical, medical, and mental condition that would make participation in the study inadvisable.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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プラセボコンパレーター：Experimental (Normal Saline)
Morphine patient-controlled-anesthesia (PCA) for the initial 24 hours post-operation with a low-dose basal rate (0.5mg/hr) and patient administered boluses prn.
Oral oxycodone from 24-48 hours post-operation will be used prn for pain and then patients will be transitioned to oral combined oxycodone/acetaminophen for the remainder of their hospital stay.
Normal saline 100cc IV will be infused as placebo every 6 hours for a total of eight doses with the first dose being given at time of anesthesia induction.
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Normal saline (100cc) will be given IV as the placebo medication every six hours for a total of eight doses with the first dose being given at time of anesthesia induction.
他の名前：
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アクティブコンパレータ：Experimental (IV Acetaminophen)
Morphine PCA for the initial 24 hours post-operation with low-dose basal rate (0.5mg/hr) with patient administered boluses prn.
IV acetaminophen 1,000mg will be given every six hours for a total of eight doses with the first dose being given at time of anesthesia induction.
Oral oxycodone from 24-48 hours post-operation will be used prn and then patients will be transitioned to oral combined oxycodone/acetaminophen for the remainder of their hospital stay.
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IV acetaminophen (1,000mg) will be given every six hours for a total of eight doses with the first dose being given at time of anesthesia induction.
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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Opioid Rescue - 48 Hours
時間枠：First 48 hours including pre-operative and intra-operative medications
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Mean number opioid rescue in the first 48 hours calculated by converting all opiates to intravenous morphine
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First 48 hours including pre-operative and intra-operative medications
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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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Return of Bowel Function
時間枠：Duration of hospital stay (up to 7 days).
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Time to return of bowel function (passage of flatus) in hours
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Duration of hospital stay (up to 7 days).
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Patient Satisfaction - Pain Control at 24 Hours, 48 Hours, and Discharge
時間枠：At 24 hours 48 hours, and discharge (up to 7 days)
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Subjects will rate their overall satisfaction with pain control on a 5-point Likert scale: 1=Strongly disagree; 2=Disagree; 3=Neutral; 4=Agree; 5=Strongly Agree
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At 24 hours 48 hours, and discharge (up to 7 days)
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Patient Satisfaction - Nausea Control at 24 Hours, 48 Hours, and Discharge
時間枠：At 24 hours, 48 Hours, and Discharge (up to 7 days)
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Subjects will rate their overall satisfaction with nausea control on a 5-point Likert scale 1=Strongly disagree; 2=Disagree; 3=Neutral; 4=Agree; 5=Strongly Agree
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At 24 hours, 48 Hours, and Discharge (up to 7 days)
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Patient Satisfaction - Bloating at 24 Hours, 48 Hours, and Discharge
時間枠：At 24 hours, 48 Hours, and Discharge (up to 7 days)
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Subjects will rate their overall satisfaction with bloating on a 5-point likert scale 1=Strongly disagree; 2=Disagree; 3=Neutral; 4=Agree; 5=Strongly Agree
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At 24 hours, 48 Hours, and Discharge (up to 7 days)
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Patient Satisfaction - Pruritis at 24 Hours, 48 Hours, and Discharge
時間枠：At 24 hours, 48 Hours, and Discharge (up to 7 days)
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Subjects will rate their overall satisfaction with pruritis control on a 5-point likert scale 1=Strongly disagree; 2=Disagree; 3=Neutral; 4=Agree; 5=Strongly Agree
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At 24 hours, 48 Hours, and Discharge (up to 7 days)
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Length of Stay
時間枠：Surgery to discharge
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Mean length of post-operative stay in days
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Surgery to discharge
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Laura K Randolph, DO, MS、Aultman Health Foundation
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2013年12月24日
一次修了 (実際)
2014年6月4日
研究の完了 (実際)
2014年6月4日
試験登録日
最初に提出
2014年1月2日
QC基準を満たした最初の提出物
2014年1月6日
最初の投稿 (見積もり)
2014年1月7日
学習記録の更新
投稿された最後の更新 (実際)
2019年1月16日
QC基準を満たした最後の更新が送信されました
2019年1月2日
最終確認日
2019年1月1日
詳しくは
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