Intrathecal Morphine Versus Bilateral Quadratus Lumborum Blocks for Perioperative Analgesia in Pediatric Patients Undergoing Open Lower Abdominal Procedures: A Prospective Randomized Trial
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Duration of Analgesia - Pain Score 0-10
研究概览
简要总结
Patients between the ages of 12 months and 11 years who are undergoing an open lower abdominal procedure will be randomized to receive intrathecal morphine, or bilateral quadratus lumborum block. The investigators will compare the effect that intrathecal morphine and quadratus lumborum blocks have on the duration of pain control as demonstrated by charted pain scores and morphine equivalents in the first 48 hours. This study will also assess the side effects of each intervention such as nausea and vomiting, and itching.
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)
盲法说明
The patient and their parent/guardians will be blinded.
入排标准
- 年龄范围
- 12 Months 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 12 months to 11 years old
- •Undergoing an open lower abdominal procedure
排除标准
- •Allergy to morphine or amide local anesthetics
- •Localized rash at site of planned regional anesthetic block
- •Bleeding diathesis
- •Spinal dysmorphism
- •Previous spinal surgery with instrumentation of the lumbar spine
- •Inability or unwillingness of parent or legal guardian to give informed consent.
- •Prior enrollment and randomization in this study
研究组 & 干预措施
Intrathecal Morphine
Intrathecal Morphine: spinal (neuraxial) dose of preservative free morphine (duramorph), usually about 4-5mcg/kg
干预措施: Intrathecal Morphine (Drug)
quadratus lumborum block
Quadratus Lumborum Block: peripheral nerve block utilizing ropivacaine 0.2%, usually about ½ mL per kg per side (total dose approximately 1mL/kg).
干预措施: Quadratus lumborum block (Drug)
结局指标
主要结局
Duration of Analgesia - Pain Score 0-10
时间窗: Up to 24 hours post-op
The primary endpoint will compare the effect that intrathecal morphine and quadratus lumborum blocks have on the duration of analgesia as demonstrated by charted pain scores in the first 24 hours. Pain scores were collected from the medical record on a scale from 0-10; the higher the score, the worse the outcome/pain. Time points in the 24 hours post op for each patient varied based on nursing care as the data was collected from the medical record.
Duration of Analgesia - MME/kg in First 24 Hours
时间窗: Up to 24 hours post-op
The primary endpoint will compare the effect that intrathecal morphine and quadratus lumborum blocks have on the duration of analgesia as demonstrated by morphine milligram equivalents (MME)/kg in the first 24 hours. The higher the MME/kg, the worse the pain.
次要结局
- Number of Participants With Side Effects of Each Intervention(up to 48 hours post-operative)
- Severity of Side Effects With Each Intervention(0-48 hours post-operatively)
- Patient/Family Satisfaction(up to 48 hours post-operative)
- Total Length of PACU Stay - Minutes(time to discharge after surgery, (an expected average length of hospital stay is approximately 2-4 days))
- Total Length of Hospital Stay - Length of Stay, Days(time to discharge after surgery, (an expected average length of hospital stay is approximately 2-4 days))
研究者
Natalie Barnett
Principal Investigator
Medical University of South Carolina