Comparison of Multimodal Analgesic Regimen With Intravenous Acetaminophen to Standard Oral Multimodal Therapy in Primary Total Hip Arthroplasty: A Randomized Controlled Double Blind Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- 24 Hour Opioid Consumption
研究概览
简要总结
The purpose of this study is to determine if intravenous acetaminophen is superior to oral acetaminophen when used as part of a multimodal pathway for primary total hip arthroplasty.
详细描述
This is a single center, prospective, randomized controlled study. 60 subjects will be recruited (see #6 Recruitment and Compensation below). On the day of surgery, subjects will be randomized to receive either the study intervention (intravenous acetaminophen and placebo tablets) or the control intervention (intravenous saline and active acetaminophen tablets). The Investigational Drug Service will prepare each intervention package, which will include one intravenous and one oral medication dose. Only one of these routes will be active (determined by randomization). Subjects will receive doses of both an intravenous and oral study drug every 6 hours in order to maintain blinding, and will receive a total of 4 doses of each (at 0, 6, 12 and 18 hours). The dose of acetaminophen in all cases will be 1000 mg. The volume of intravenous acetaminophen (and saline) will be 100 mL. The oral dose will consist of two (2) tablets of 500 mg each (or two matching placebo tablets).
All subjects will receive a standardized anesthetic regimen for total hip arthroplasty, as follows:
A) Preoperative phase
Subjects will receive the following preoperative multimodal drugs:
- Pregabalin 75 mg PO
- Celecoxib 200 mg PO
- The interventional drugs, both IV and PO . The time that these drugs are administered will be recorded as time zero. Patients will then receive a spinal anesthetic with 12.5 mg of isobaric bupivacaine. No peripheral nerve blocks will be performed.
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
- 56 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for elective, primary total hip replacement for osteoarthritis
- •American Society of Anesthesiologists (ASA) Physical Classification I-III
- •Weight 50 kg or greater
- •Body mass index 18-40 kg/m2
排除标准
- •Inability to consent to study
- •Inability to speak English
- •Pregnancy
- •Weight <50 kg
- •Revision hip replacement or emergency surgery
- •Contraindications to spinal anesthesia: coagulopathy or bleeding diathesis, local infection, allergy to local anesthetics
- •Allergies/intolerances/contraindications to any of the multimodal agents: acetaminophen, pregabalin, celecoxib, ketamine, or dexamethasone
- •Chronic pain from a separate source other than operative hip
- •Daily opioid equivalent use of 30 mg of morphine or greater at time of consent
- •History of heart failure
- •History of drug or alcohol abuse
- •Rheumatoid arthritis
- •Uncontrolled anxiety, schizophrenia or other psychiatric disorder that, in the opinion of the investigator, may interfere with the study assessments
- •Chronic malnutrition, renal or liver impairment
- •Hypersensitivity to acetaminophen or any of its excipients
研究组 & 干预措施
Intravenous acetaminophen
Subjects receive 1000 mg acetaminophen IV immediately preoperatively, as well as at 6, 12, and 18 hours postoperatively. At the same time points, subjects will receive an oral placebo.
干预措施: Intravenous acetaminophen (Drug)
Oral acetaminophen
Subjects receive 1000 mg acetaminophen PO immediately preoperatively, as well as at 6, 12, and 18 hours postoperatively. At the same time points, subjects will receive an intravenous placebo.
干预措施: Oral acetaminophen (Drug)
结局指标
主要结局
24 Hour Opioid Consumption
时间窗: 24 hours
Cumulative dose of hydromorphone consumed in the first 24 hours postoperatively
次要结局
- Opioid Consumption (Other)(0-48 hours)
- Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (Preoperatively)(preoperatively)
- Pain Scores, as Measured by the 11-point Numeric Rating Scale (NRS-11) (1 Hour After Arrival to PACU)(1 hour after arrival to PACU)
- Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (8 Hours)(8 hours)
- Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (36 Hours)(36 hours)
- Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (24 Hours)(24 hours)
- Self-paced Walk Test(Postoperative day 1)
- Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (48 Hours)(48 hours)
- Subject Satisfaction at 24 Hours(24 hours)
- Subject Satisfaction at 48 Hours (48 Hours)(48 hours)
- Straight Leg Raise(Postoperative day 1)
- Heel Slide Test(Postoperative day 1)
- Number of Participants Able to Complete the Supine to Sit Test(Postoperative day 1)
- Number of Participants With Opioid-related Adverse Events(0-72 hours)
- Analgesic Consumption as Measured by Patient Diary(day 30)
- Worst Pain (Day 30)(day 30)
- Subject Satisfaction at 48 Hours(48 hours)