NCT04368364终止4 期
A Randomized Control Trial Comparing Analgesic Benefits of Ultrasound-guided Single vs Continuous Quadratus Lumborum Blocks vs Intrathecal Morphine for Post Cesarean Section Pain
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Total Narcotic Consumption in Morphine Equivalents (in Milligrams)
研究概览
简要总结
the purpose of this study is to compare opioid consumption in morphine equivalents between the groups that received postoperative analgesia with intrathecal morphine versus US guided QL blocks versus US guided QL catheters
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, 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
- 是
入选标准
- •Elective C section via Pfannenstiel incision
- •Living singleton pregnancy
- •Gestation week at least 37 weeks
- •American Society of Anesthesiologists (ASA) status 1, 2 and 3
- •Primary and secondary C sections
排除标准
- •Chronic pain
- •Opioid tolerant patients
- •Allergy to drugs used in the study.
- •Cognitive dysfunction
- •BMI > 40
- •Coagulation disorder
- •Local infection
- •Inability to tolerate oral medication
- •Previous intra-abdominal surgery
- •Patients who will receive a combined spinal epidural for their C section
- •Local anesthetics injected at any other fascial plane except the QLB plane (for e.g.- local wound infiltration by surgeon)
- •Patients who received sedation or general anesthesia during their C section (midazolam, ketamine, fentanyl, propofol, hydromorphone)
研究组 & 干预措施
Group 1 (Control group)
Active Comparator
干预措施: Intrathecal morphine sulfate (ITM) (Drug)
Group 2(Bupivacaine hydrochloride group)
Experimental
干预措施: Bupivacaine hydrochloride (Drug)
Group 3 (ropivacaine hydrochloride group)
Experimental
干预措施: ropivacaine hydrochloride (Drug)
结局指标
主要结局
Total Narcotic Consumption in Morphine Equivalents (in Milligrams)
时间窗: upto 72 hours post surgery
Total narcotic consumption in morphine equivalents (in milligrams) for the first 72 hours after surgery was calculated.
次要结局
- Total Narcotic Consumption in Morphine Equivalents (in Milligrams)(12,24,48 hours post surgery)
- Static Pain as Measured by the Numerical Pain Score (NPS)(6, 12, 24, 48 and 72 hours post surgery)
- Severity of Pruritus as Assessed by a Scale(24, 48 and 72 hours post surgery)
- Severity of Nausea as Assessed by a Scale(24, 48 and 72 hours post surgery)
- Severity of Vomiting as Assessed by a Scale(24, 48 and 72 hours post surgery)
- Severity of Sedation as Assessed by a Scale(24, 48 and 72 hours post surgery)
- Patient Satisfaction as Assessed by Likert Scale(72 hours post surgery)
- Dynamic Pain as Measured by the Numerical Pain Score (NPS)(6, 12, 24, 48 and 72 hours post surgery)
- Time to First Analgesic Request(72 hours post surgery)
研究者
Sudipta Sen
Assistant Professor
The University of Texas Health Science Center, Houston
研究点 (2)
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