A Randomized Controlled Trial for Postoperative Analgesia in Patients Undergoing Elective Lumbar Fusion Operations Under General Anesthesia: Ultrasound Guided Erector Spinae Plane Block Versus Intrathecal Morphine
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Time to first requested rescue analgesia (Minutes).
研究概览
简要总结
It was proven that intrathecal opioids are considered as an effective means of pain control in several major surgical interventions including spine surgeries. Intrathecal morphine added to a spinal anesthesia reduces acute pain after spine surgeries but has side effects, including dose dependent respiratory depression, nausea, vomiting, pruritus, and sedation. Ultrasound guided Erector Spinae Plane Block (ESPB) was first described in 2016.Recent case reports suggest a positive effect of ultrasound guided ESPB on pain for multiple indications including lumbar spine fusion and scoliosis surgery, with a very low risk of complications as there are no structures in close proximity at risk of needle injury.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 21 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body mass index (BMI) 25 to 35 kg/m².
- •American Society of Anesthesiologist (ASA) physical status I or II.
排除标准
- •patient's refusal
- •Altered mental status
- •Known allergy to study drugs (bupivacaine or morphine)
- •Local infection at site of puncture.
- •Known case with any pulmonary disease
- •Known case with Obstructive sleep apnea (OSA)
- •Coagulopathy and /or thrombocytopenia
- •Severe hepatic or kidney impairment
研究组 & 干预措施
General anesthesia and Ultrasound Guided Erector Spinae Plane Block
干预措施: Ultrasound Guided Erector Spinae Plane Block (Procedure)
General anesthesia and intrathecal morphine
干预措施: Intrathecal morphine (Drug)
General anesthesia using intravenous fentanyl (1µg/kg)
干预措施: General anesthesia using intravenous fentanyl (1µg/kg) (Other)
结局指标
主要结局
Time to first requested rescue analgesia (Minutes).
时间窗: First 24 hours after surgery.
Time to first requested rescue analgesia (Minutes).
次要结局
未报告次要终点
研究者
Ibrahim Mamdouh Esmat
Assistant Professor of Anesthesia and Intensive Care Department, Faculty of Medicine, Ain- shams University, Cairo, Egypt.
Ain Shams University