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
研究概览
详细说明
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.
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
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Pennsylvania
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Pittsburgh、Pennsylvania、美国、15213
- Magee Womens Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:三倍
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的: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.
其他名称:
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安慰剂比较: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.
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Postoperative Pain
大体时间: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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Narcotic Medication Use
大体时间: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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其他结果措施
结果测量 |
措施说明 |
大体时间 |
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Having a Feeling of General Well-being at One Month
大体时间: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
大体时间: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
大体时间: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
大体时间: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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合作者和调查者
调查人员
- 首席研究员:Noah Rindos, MD、Faculty
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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