Intravenous Acetaminophen Versus Saline in Postoperative Analgesia After Laparoscopic Hysterectomy: A Randomized, Double Blind, Placebo Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 183
- 试验地点
- 1
- 主要终点
- Postoperative Pain
研究概览
简要总结
The objective of this study is to quantify the change in post-operative pain scores and narcotic requirements in women receiving pre and post-operative IV acetaminophen compared to placebo in women undergoing laparoscopic hysterectomy.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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.
研究组 & 干预措施
Intravenous IV acetaminophen
The patients in the treatment arm will receive 1000mg of IV acetaminophen.
干预措施: IV acetaminophen (Drug)
Normal Saline
The patients in the placebo arm will receive normal saline.
干预措施: placebo (Drug)
结局指标
主要结局
Postoperative Pain
时间窗: 24 hours
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.
次要结局
- Narcotic Medication Use(24 hours)
研究者
Noah Rindos
Fellow in Minimally Invasive Gynecology
University of Pittsburgh
