Time of Intravenous Acetaminophen Administration for Total Hip Arthroplasty
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Changes in Postoperative Pain Scores
研究概览
简要总结
The purpose of the study is to examine the effects of timing of administration of intravenous (IV) acetaminophen and how timing relates to analgesic efficacy as measured by postoperative pain scores. A maximum of 138 patients meeting inclusion criteria who present for a scheduled total hip replacement under general anesthesia will be randomized into one of two arms: 1) the pre-closure group will receive the first dose administered upon onset of skin closure, 2) the preemptive group will receive the first dose administered within 60 minutes prior to incision. Both groups will receive subsequent doses every 6 hours x 24 hours.
详细描述
The purpose of the study is to examine the effects of timing of administration of intravenous (IV) acetaminophen and how timing relates to analgesic efficacy as measured by postoperative pain scores. A maximum of 138 patients meeting inclusion criteria who present for a scheduled total hip replacement under general anesthesia will be randomized into one of two arms: 1) the closure group will receive the first dose of one gram of intravenous acetaminophen administered upon onset of skin closure, 2) the preemptive group will receive the first dose of one gram of intravenous acetaminophen administered within 60 minutes prior to incision. Both groups will receive subsequent doses of one gram of intravenous acetaminophen every 6 hours x 24 hours. The maximum dose in a 24 hour period will not exceed 4 grams according to FDA recommendations.
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
- Single (Participant)
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 30-75 years of age weighing ≥55 kg scheduled for elective total hip arthroplasty performed under general anesthesia will be included. As determined by the anesthesia team assigned to the case, eligible patients will also be assigned ASA physical status of I, II, or III and deemed capable of reporting their perceived pain using numeric pain scales and capable of operating a patient controlled anesthesia (PCA) device.
排除标准
- •Exclusion criteria include known allergy, hypersensitivity, or contraindication to acetaminophen, history of alcohol or drug abuse, prisoners, emergency THAs, patients with chronic malnutrition or a body mass index (BMI) < 18 kg/m2 and non-English speaking patients. Additional exclusion criteria include impaired liver function defined as AST and ALT each ≥ twice normal limits and renal dysfunction (creatinine >2.0 mg/dl).
研究组 & 干预措施
Preemptive group
The preemptive group will receive one dose of 1 gram of IV acetaminophen every 6 hours x 24 hours with the first dose administered within 60 minutes prior to incision. Each infusion will be administered over 15 minutes as recommended by manufacturer package insert.
干预措施: Acetaminophen (Drug)
Closure group
The closure group will receive one dose of 1 gram of IV acetaminophen every 6 hours x 24 hours with the first dose administered upon onset of skin closure.
干预措施: Acetaminophen (Drug)
结局指标
主要结局
Changes in Postoperative Pain Scores
时间窗: preoperatively (baseline), post-anesthesia care unit (PACU or recovery room) arrival (2-3 hour), and 6,12, 18, and 24 hours following the initial administration of the study drug
To compare analgesic efficacy as measured by changes in postoperative pain scores assessed preoperatively, at 6, 12, 18, and 24 hours following the initial administration of the study drug. Pain scores are assessed on a scale of 0 - 10. 0 = No Pain; 10 = Worst Possible Pain
次要结局
- Pain Medication Consumption Rates(Arrival to post-anesthesia care unit (PACU or recovery room) (2-3 hours post baseline) to 24 hours post administration of study drug)