A Comparison of IV Versus PO Acetaminophen Postoperatively for Opioid Consumption After Cesarean Section
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Narcotic Utilization
研究概览
简要总结
This randomized controlled study will compare narcotic consumption between two groups: patients that receive a perioperative dose of IV acetaminophen versus patients that receive a perioperative dose of oral liquid acetaminophen for scheduled cesarean section.
详细描述
"Enhanced recovery" is an alternate management protocol described by a multi-modal, evidence based approach to peri-operative care, with the goal of accelerating recovery and return to normal activity after surgery. Results have shown stable pain control with a decrease in narcotic consumption, a quicker return of bowel function, and decreased length of hospital stay and cost with no change in level of patient satisfaction, morbidity, or readmission rate. An aspect of some alternate management protocols is the administration of acetaminophen.
The concentration of acetaminophen in cerebrospinal fluid (CSF) is directly proportional to the analgesic activity of acetaminophen. Acetaminophen relies on a high concentration gradient from the plasma to the CSF in order to passively diffuse into the central nervous system (CNS), its principal site of action. A 2012 study, comparing plasma and CSF pharmacokinetics of intravenous (IV), oral (PO), or rectal (PR) acetaminophen, concluded that IV administration of acetaminophen results in higher plasma and CSF concentration values. Therefore, IV acetaminophen produces better CNS penetration compared to PO or PR methods.
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)
盲法说明
When the Principal Investigator calls to enroll patient into the study, pharmacy will be responsible for labelling and delivering the drugs to the labor and delivery unit. The label will include the patient enrollment number and the study name. The investigators will be blind to the patient's drug/placebo assignment. In case of emergency, side effects, or allergic reaction, the pharmacy will be contacted to unblind medication.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women age 18 or older
- •Scheduled to undergo a cesarean section
排除标准
- •Existing diagnosis of chronic pain
- •Need to undergo a vertical skin incision
- •Aspartate Aminotransferase (AST) > 50, alanine aminotransferase (ALT) > 70
- •Platelets below 80,000 on admission
- •Need to undergo general anesthesia
- •Tubal ligation at time of Cesarean section
- •Prior or known allergy to any of the medications being utilized in this study
研究组 & 干预措施
Intravenous Administration of Acetaminophen
A single peri-operative dose of acetaminophen 1000 mg IV over 15 minutes after skin is closed.
干预措施: Acetaminophen (Drug)
Intravenous Administration of Acetaminophen
A single peri-operative dose of acetaminophen 1000 mg IV over 15 minutes after skin is closed.
干预措施: Placebos (Drug)
Per Oral Administration of Acetaminophen
A pre-operative liquid dose of acetaminophen 1000mg orally in the on-call to Operative Room.
干预措施: Acetaminophen (Drug)
Per Oral Administration of Acetaminophen
A pre-operative liquid dose of acetaminophen 1000mg orally in the on-call to Operative Room.
干预措施: Placebos (Drug)
结局指标
主要结局
Narcotic Utilization
时间窗: 6 hours post operative
The Center for Disease Control and Prevention Morphine Milligram Equivalent Score will be used to calculate total narcotic use (conversion factor for administered opioid x milligrams administered) while the patient remains as an inpatient.
次要结局
- Post-operative Pain Level(Every hour for six hours post-op)
- Postoperative complications during the inpatient stay(Up to 24 hours)
- Patient Satisfaction(Up to 24 hours)
研究者
Dmitri Chamchad
Anesthesia Research Director
Main Line Health