Double Blinded Randomized Placebo Controlled Study in Evaluating the Effectiveness of IV Acetaminophen for Acute Post Operative Pain in C-Section Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Opioid Requirements in Cesarean Section (C-section) Patient Population
研究概览
简要总结
Post-operative pain management after C-section is an important topic as the number of elective c-sections increases each year. Pain is managed either by giving opioids or by using non-opioids. The purpose of this study is to evaluate the effectiveness of IV Acetaminophen in pain relief and its impact in the usage of post-operative opioid requirements and opioid associated complications. The hypothesis is that four doses of IV Acetaminophen in conjunction with intrathecal or epidural morphine given to the patients after c-section will reduce post-operative opioid requirements and opioid associated complications.
详细描述
Most of the opioids used are centrally acting drugs like morphine or its derivatives. The most common adverse reactions related to systemic administration of opioids are sedation, itching, constipation and less commonly, respiratory depression. One of the other management strategies for the pain control is the use of non-steroidal anti-inflammatory drugs (NSAIDS). Frequent use of NSAIDS is also associated with complications, such as gastric ulcer and platelet dysfunction. When compared to other non-NSAIDS, IV acetaminophen is a relatively safer drug with quicker onset of action. In an earlier conducted study, the onset of action of analgesia for a bolus dose of IV acetaminophen is 3 minutes. IV acetaminophen is FDA approved for management of mild to moderate pain. An adverse reaction associated with the prolonged usage of IV acetaminophen is hepatic injury. The most common adverse events encountered during previous clinical trials were nausea, vomiting, headache and insomnia.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Elective full term CS patients
- •Age 18 and above
- •ASA I-III
排除标准
- •Allergic reaction to IV acetaminophen
- •Not able to understand and sign the research consent
- •Pregnancy induced hypertension or pre-eclampsia patients
- •Planned intensive care admission patients
- •Patients with severe hepatic impairment or active liver diseases (Two fold increase in any of the liver enzymes)
- •Patients with serum creatinine>2mg/dl
- •For nursing mothers, any evidence of hepatic dysfunction of the new born
研究组 & 干预措施
IV Acetaminophen
IV form, total of 4 doses (each 1000 mg), each every 6th hourly to a maximum dose of 4000 mg in 24 hours.
干预措施: IV Acetaminophen (Drug)
Saline as placebo
IV form, total 4 units, each given every 6th hourly in 24 hours.
干预措施: Saline as placebo (Other)
结局指标
主要结局
Opioid Requirements in Cesarean Section (C-section) Patient Population
时间窗: 24 and 48 hours after Cesarean Section
次要结局
- Number of Participants Using Patient-controlled Analgesia (PCA) Attempts(every 6 hours for the first 24 hours after the c-section and there after every 8 hours until the patient is discharged or upto 72 hours.)
- Percentage of Participants That Were Re-Hospitalized 1 Week After Discharge(From time of discharge to 1 week after discharge)
- Pain Medication Usage ( NSAIDS)(For the first 24 hours after the c-section until the patient is discharged or up to 48 hours)
- Visual Analog Score (VAS) Pain Score(every 6 hours for the first 24 hours after the c-section and there after every 8 hours until the patient is discharged or up to 48 hours)
- Percentage of Participants Reporting to be Wide Awake up to 72 Hours After the C-section(Percentage of Participants Reporting to be Wide Awake up to 72 hours after the C-section)
- "Percentage of Patients With Adverse Events After the Surgery(every 6 hours for the first 24 hours after the c-section and there after every 8 hours until the patient is discharged or upto 72 hours. Finally, 1 week after discharge.)
研究者
Singh Nair
Asst Prof, Anesthesiology
Montefiore Medical Center