Effect of Intravenous Acetaminophen on Postoperative Opioid-related Complications
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 580
- 试验地点
- 1
- 主要终点
- Duration of Hypoxemia
研究概览
简要总结
Some patients have respiratory depression (decreased breaths per minute) after surgery. Acetaminophen, an FDA approved pain medication, may prevent this problem. The purpose of this study is to determine if acetaminophen decreases respiratory depression after surgery. The investigators will also evaluate the cost effectiveness of acetaminophen.
Patients having elective major abdominal surgery are being asked to participate in this research study. If eligible, a patient will have their baseline tidal volume (amount of air moved into or out of the lungs) and vital capacity (how much air the lungs are capable of holding) measured using a spirometer (apparatus for measuring the volume of air inspired and expired by the lungs) measured before surgery. Three questionnaires will also need to be completed before surgery.
The patient will then be randomized, like flipping a coin, to receive either Acetaminophen or placebo (inactive substance) as an infusion throughout surgery and for the first two days thereafter. Neither the patient nor his or her physician will know if the patient is assigned to study drug or placebo. Regardless of study assignment, both groups will receive standard pain management medications and sedation.
After surgery, the patient's blood pressure, activity, posture, respiratory rate, the electrical activity of the heart, oxygen saturation, tidal volume, minute ventilation and respiratory rate will be continuously monitored and recorded for 48 hours using a wireless pulse-oximeter and a respiratory volume monitor.
48 hours after surgery the patient will be asked to complete a patient satisfaction questionnaire, which will allow the patient to rate the satisfaction with the treatment received for pain. The patient will also be asked to complete a questionnaire about recovery.
At discharge, the patient will be given two questionnaires about pain and quality of life.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Written informed consent
- •18-85 years old
- •above 50 kg
- •American Society of Anaesthesiologists Physical Status 1-3
- •Scheduled for elective open or laparoscopic abdominal surgery, including colorectal, prostate, and hysterectomy surgeries
- •Patients with anticipated hospitalization of two nights
- •Expected to require parenteral opioids for at least 48 hours for postoperative pain
- •Able to use IV Patient-Controlled Analgesia systems
排除标准
- •Hepatic disease, e.g. twice the normal levels of liver enzymes
- •Kidney disease, e.g. twice the normal level of serum creatinine
- •Epidural analgesia or regional blocks (including Transverse abdominis plane block)
- •Acetaminophen sensitivity or known allergy
- •Female patients who are pregnant or breastfeeding
- •Patients taking warfarin
研究组 & 干预措施
Intravenous 0.9% sodium chloride
0.9% sodium chloride infusion will be initiated before the surgical incision with 100 ml and repeated every 6 hours for the earlier of 48 postoperative hours of hospital discharge.
干预措施: Intravenous Acetaminophen (Drug)
Intravenous Acetaminophen
Acetaminophen infusion will be initiated before the surgical incision with 1 g and repeated every 6 hours for the earlier of 48 postoperative hours of hospital discharge.
干预措施: Intravenous Acetaminophen (Drug)
结局指标
主要结局
Duration of Hypoxemia
时间窗: the initial 48 hours of postoperative monitoring or for the duration of hospitalization, if shorter.
Hypoxemia is measured as minutes with hypoxemia (Spo2 \<90%) per hour of successful Spo2 monitoring. Patients will have nearly continuous pulseoximeter monitoring and recording. Data from the monitor will be downloaded daily for 48 hours postoperatively.
次要结局
- Fatigue Score on Morning of Postoperative Day 1(Postoperative day 1)
- Lowest RASS Score During Initial 48 Postoperative Hours(Initial 48 postoperative hours or duration of hospitalization (whichever comes first))
- Incidence of Postoperative Nausea and Vomiting(Initial 48 postoperative hours or duration of hospitalization (whichever comes first))
- Time Weighted Pain Score in Post Anesthesia Care Unit(Initial 48 postoperative hours or duration of hospitalization (whichever comes first))
- Opioid Consumption - Intravenous Morphine Equivalents(Initial 48 postoperative hours)
- Total Anesthetic Dose From Induction to Extubation(Induction to extubation (3 hours on average))
- Time-weighted Pain Score During Initial 48 Postoperative Hours(Initial 48 postoperative hours or duration of hospitalization (whichever comes first))
- Time Spent in Sitting or Upright Position(Initial 48 postoperative hours or duration of hospitalization (whichever comes first))
- Incidence of Low Respiratory Function Event(Initial 48 postoperative hours or duration of hospitalization (whichever comes first))
研究者
Alparslan Turan
Associate Staff Anesthesiologist
The Cleveland Clinic