Comparison of Analgesic Efficacy of Mid-Transverse Process to Pleura (MTP) Block and Intrathecal Morphine in Idiopathic Scoliosis Patients Undergoing Posterior Spinal Fusion: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Degree of pain
研究概览
简要总结
The aim of this study is to compare the analgesic efficacy of mid-transverse process to pleura (MTP) block and intrathecal morphine in idiopathic scoliosis patients undergoing posterior spinal fusion surgery.
详细描述
The postoperative period for idiopathic scoliosis patients undergoing posterior spinal fusion (PSF) is fraught with challenges, including adequate postoperative pain control and prolonged hospitalization.
Intrathecal opioids have been used to manage postoperative pain in pediatric patients for a wide variety of surgeries , including adolescent and adult PSF. Multimodal analgesic (MMA) regimens using several drugs and techniques are considered to be necessary for postoperative pain relief.
The mid-transverse process to pleura (MTP) block was first described as a modified paravertebral block in 2017. The local anesthetics (LAs) are administered between the transverse process and the pleura. This results in a LA spread to the dorsal and ventral rami in the paravertebral space through the fenestrations in the superior costotransverse ligament at the level of injection, and frequently to adjacent levels.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years.
- •Both sexes.
- •American Society of Anesthesiology (ASA) physical status I-II.
- •Idiopathic scoliosis patients undergoing posterior spinal fusion surgery.
排除标准
- •Patient with morbid obesity (body mass index >40 kg/m2).
- •Patients with pre-existing infection at block site.
- •Known allergy to study drugs.
- •Coagulation disorder.
- •History of psychiatric illness.
- •Pre-existing neurological deficits.
- •Presence of any pre-operative pain or history of chronic pain.
- •History of regular analgesic.
研究组 & 干预措施
Mid-Transverse Process block (MTP) group
Patients will receive mid-transverse process to pleura (MTP) block after induction of anesthesia.
干预措施: Ultrasound-Guided Mid-Transverse Process to Pleura (MTP) Block (Device)
Intrathecal morphine (IM) group
Patients will receive intrathecal morphine in a dose of 12 μg/kg (max 1000 μg) immediately after induction of anesthesia.
干预措施: Morphine (Drug)
结局指标
主要结局
Degree of pain
时间窗: 24 hours postoperative
Degree of pain will be assessed by the Visual Analogue Scale (VAS). VAS (0 represents "no pain" while 10 represents "the worst pain imaginable"). It will be assessed at 0, 4, 8, 12, 18 and 24h postoperatively.
次要结局
- Heart rate(Till the end of surgery.)
- Mean arterial pressure(Till the end of surgery.)
- Patient satisfaction(24 hours postoperative.)
- Complications(24 hours postoperative.)
研究者
Mohammed Said ElSharkawy
Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.
Tanta University