Intravenous Versus Oral Acetaminophen in Primary Total Hip Arthroplasty
Comparison of Multimodal Analgesic Regimen With Intravenous Acetaminophen to Standard Oral Multimodal Therapy in Primary Total Hip Arthroplasty: A Randomized Controlled Double Blind Trial
研究概览
详细说明
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.
B) Intraoperative phase All subjects will be receive propofol infusion beginning at 50 mg/kg/min and titrated to a Richmond Agitation-Sedation Scale score of -1 to -3 (drowsy to moderate sedation). Dexamethasone 10 mg IV and ketamine 0.25 mg/kg IV up to 40 mg total will be administered as part of the standard multimodal regimen. If required, subjects may receive fentanyl 25 mcg IV as needed to treat discomfort. No joint infiltration will be performed by the surgeon.
C) Postoperative phase In the Post-Anesthesia Care Unit (PACU), subjects will have an intravenous patient-controlled analgesia (IVPCA) device connected and loading doses of hydromorphone administered by the PACU nurse as necessary (0.2 mg q 8 min prn).
On the floor, subjects will receive:
- Pregabalin 75 mg PO BID until discharge
- Celecoxib 200 mg PO BID until discharge
- Dexamethasone 10 mg IV x 1 on postoperative day 1 (24 hours after the first dose)
- Intravenous patient-controlled analgesia (IVPCA) with hydromorphone (0.2 mg q 8 min).
The remaining 3 intervention packages (IV and PO) will be administered at 6, 12 and 18 hours following the first dose. At time point 24 hours (i.e. the fifth dose of acetaminophen), all subjects will begin to receive 975 mg of oral acetaminophen, continuing every six hours until 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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North Carolina
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Durham、North Carolina、美国、27710
- Duke University 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:
- 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
Exclusion Criteria:
- 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
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:四人间
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的: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.
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Subject receives 1 g acetaminophen by the intravenous route every 6 hours for 4 doses beginning in the preoperative holding area.
其他名称:
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有源比较器: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.
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Subject receives 1 g acetaminophen by the oral route every 6 hours for 4 doses beginning in the preoperative holding area.
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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 |
---|---|---|
24 Hour Opioid Consumption
大体时间:24 hours
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Cumulative dose of hydromorphone consumed in the first 24 hours postoperatively
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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 |
---|---|---|
Opioid Consumption (Other)
大体时间:0-48 hours
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morphine equivalent units of intravenous and oral opioids
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0-48 hours
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Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (Preoperatively)
大体时间:preoperatively
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Pain scores (using NRS-11 scale) with active range of motion of the hip.
Participants rate their pain on an 11-point scale (0=no pain at all, 10=worst imaginable pain).
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preoperatively
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Pain Scores, as Measured by the 11-point Numeric Rating Scale (NRS-11) (1 Hour After Arrival to PACU)
大体时间:1 hour after arrival to PACU
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Pain scores (using NRS-11 scale) at rest.
Participants rate their pain on an 11-point scale (0=no pain at all, 10=worst imaginable pain).
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1 hour after arrival to PACU
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Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (8 Hours)
大体时间:8 hours
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Pain scores (using NRS-11 scale) at rest.
Participants rate their pain on an 11-point scale (0=no pain at all, 10=worst imaginable pain).
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8 hours
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Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (24 Hours)
大体时间:24 hours
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Pain scores (using NRS-11 scale) at rest.
Participants rate their pain on an 11-point scale (0=no pain at all, 10=worst imaginable pain).
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24 hours
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Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (36 Hours)
大体时间:36 hours
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Pain scores (using NRS-11 scale) at rest.
Participants rate their pain on an 11-point scale (0=no pain at all, 10=worst imaginable pain).
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36 hours
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Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (48 Hours)
大体时间:48 hours
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Pain scores (using NRS-11 scale) at rest.
Participants rate their pain on an 11-point scale (0=no pain at all, 10=worst imaginable pain).
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48 hours
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Subject Satisfaction at 24 Hours
大体时间:24 hours
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Overall subject satisfaction with hospital experience at the 24 hour time point using a simple 11-point Likert scale to quantify global satisfaction.
0=completely unsatisfied, 10=completely satisfied.
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24 hours
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Subject Satisfaction at 48 Hours (48 Hours)
大体时间:48 hours
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Overall subject satisfaction with hospital experience at the 48 hour time point using a simple 11-point Likert scale to quantify global satisfaction.
0=completely unsatisfied, 10=completely satisfied.
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48 hours
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Straight Leg Raise
大体时间:Postoperative day 1
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Number of participants who are able to complete the active straight leg test.
The subject rests supine and is asked to lift his/her operative lower limb (with knee extended) until the ankle is 20 cm from level.
If the subject can do this, the test is positive.
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Postoperative day 1
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Heel Slide Test
大体时间:Postoperative day 1
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Number of participants who are able to complete the heel-slide test.
The subject rests supine and is asked to place the heel of his/her operative side on the contralateral knee, then slide the heel down to the ankle and back in one continuous motion.
If the subject can do this, the test is positive.
If the subject cannot do this in one motion, or if pain or other factors prevent the test from being performed, the test is negative.
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Postoperative day 1
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Number of Participants Able to Complete the Supine to Sit Test
大体时间:Postoperative day 1
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Number of participants able to go from supine to a sitting position independently.
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Postoperative day 1
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Self-paced Walk Test
大体时间:Postoperative day 1
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Time taken to walk down a hallway 20 m at a safe and quick pace, turn around and return to starting point.
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Postoperative day 1
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Number of Participants With Opioid-related Adverse Events
大体时间:0-72 hours
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Incidence of respiratory desaturation events, nausea, vomiting, pruritis, ileus, and constipation
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0-72 hours
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Analgesic Consumption as Measured by Patient Diary
大体时间:day 30
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morphine equivalent units of oral opioids and other non-opioids
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day 30
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Worst Pain (Day 30)
大体时间:day 30
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Participants are asked to rate their WORST pain on POSTOPERATIVE DAY 30 on an 11-point scale (0=no pain at all, 10=worst imaginable pain).
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day 30
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Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (Preoperatively)
大体时间:preoperatively
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Pain scores (using NRS-11 scale) at rest.
Participants rate their pain on an 11-point scale (0=no pain at all, 10=worst imaginable pain).
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preoperatively
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Pain Scores, as Measured by the 11-point Numeric Rating Scale (NRS-11) (1 Hour After Arrival to PACU)
大体时间:1 hour after arrival to PACU
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Pain scores (using NRS-11 scale) at with active range of motion of the hip.
Participants rate their pain on an 11-point scale (0=no pain at all, 10=worst imaginable pain).
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1 hour after arrival to PACU
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Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (8 Hours)
大体时间:8 hours
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Pain scores (using NRS-11 scale) with active range of motion of the hip.
Participants rate their pain on an 11-point scale (0=no pain at all, 10=worst imaginable pain).
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8 hours
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Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (24 Hours)
大体时间:24 hours
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Pain scores (using NRS-11 scale) with active range of motion of the hip.
Participants rate their pain on an 11-point scale (0=no pain at all, 10=worst imaginable pain).
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24 hours
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Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (36 Hours)
大体时间:36 hours
|
Pain scores (using NRS-11 scale) with active range of motion of the hip.
Participants rate their pain on an 11-point scale (0=no pain at all, 10=worst imaginable pain).
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36 hours
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Subject Satisfaction at 48 Hours
大体时间:48 hours
|
Overall subject satisfaction with hospital experience at the 48 hour time point using a simple 11-point Likert scale to quantify global satisfaction.
0=completely unsatisfied, 10=completely satisfied.
|
48 hours
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Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (48 Hours)
大体时间:48 hours
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Pain scores (using NRS-11 scale) with active range of motion of the hip.
Participants rate their pain on an 11-point scale (0=no pain at all, 10=worst imaginable pain).
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48 hours
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Hospital Length of Stay
大体时间:0-72 hours
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Time to both discharge readiness and to actual discharge
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0-72 hours
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Overall Hospital Admission Costs
大体时间:0-72 hours
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difference in total hospital admission cost between groups
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0-72 hours
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Pharmacy-related Costs
大体时间:0-72 hours
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difference in pharmacy-related cost between groups
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0-72 hours
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Costs Related to Opioid-related Adverse Events
大体时间:0-72 hours
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difference in cost related to treatment of opioid-related adverse events (nausea, vomiting, pruritis, constipation, respiratory depression, dizziness) between groups
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0-72 hours
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Cost Associated With Nursing Interventions and Drugs to Treat Opioid-related Adverse Events
大体时间:0-72 hours
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mean cost (per patient) related to nursing care of opioid-related adverse events (nausea, vomiting, pruritis, constipation, respiratory depression, dizziness) in $USD
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0-72 hours
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
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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