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临床试验/NCT03328390
NCT03328390已完成不适用

Analgesia for Laparotomy in Cancer Patients:Ultrasound-guided Quadratus Lumborum Block Versus Transversus Abdominis Plane Block

Alaa Mazy1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2016年1月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
102
试验地点
1
主要终点
The total dose of morphine consumption

研究概览

简要总结

Regional anesthesia of the abdomen significantly reduce postoperative pain, spare the systemic opioids and decrease postoperative nausea and vomiting. Multiple regional techniques can be performed at the neuro-axis (epidural), the nerve root (paravertebral) and the peripheral nerve (transversus abdominis plane).

Quadratus lumborum (QL) block is an addition into the league of truncal nerve block techniques that has been found to provide analgesia for abdominal surgeries. Several case reports have shown that local anesthetic injection around the quadratus lumborum muscle is effective in providing pain relief after various abdominal operations and in patients with chronic pain.

The study hypothesis is that quadratus lumborum block in single shot may be more superior to transversus abdominus plane block as regard intra-operative and the post-operative analgesia.

详细描述

This is a prospective randomized controlled study conducted at Oncology Center-Mansoura University.

102 patients were randomly allocated by closed envelope method into 2 equal groups:

  • Quadratus lumborum block Group (Q) (n= 51): patients received 15 ml of 0.5% isobaric bupivacaine + 10 ml saline + 50 ug dexmedetomidine + epinephrine (1:100,000) for each side.
  • Transversus abdominis plane Group (T) (n= 51): patients received 15 ml of 0.5% isobaric bupivacaine + 10 ml of saline + 50 ug dexmedetomidine + epinephrine (1:100,000) for each side.

All blocks were performed after induction of general anesthesia and approximately 15 min before the skin incision.

  • Technique of ultrasound guided quadratus lumborum Block: patient lie in lateral position to obtain appropriate view of quadratus lumborum and transversus abdominins plane extension of lateral abdominal muscles. In this approach, a high-frequency linear transducer (7-12 MHZ) attached to ultrasound machine was placed in anterior axillary line to visualize the typical triple abdominal layers. At the junction of the tapered ends of abdominal muscles and quadratus lumborum, a 21 G cannula needle was inserted in plane and confirmed its position by injecting saline. Under ultrasound guidance, saline separating thoracolumbar fascia from muscle is observed then local anesthetic is injected.
  • Technique of ultrasound guided Transversus abdominis plane Block: Patient lie in supine position and high-frequency linear transducer (7-12 MHZ) attached to ultrasound machine placed in anterior axillary line between costal margin and iliac crest to visualize the typical triple abdominal layers. A 21 G cannula needle is then moved forward from an anteromedial position in a posterior and lateral direction using an in-plane technique with the entry point in the skin being separated from the probe in order to improve needle visibility in the long axis. The needle tip is inserted between transversus abdominis muscle and internal oblique muscle then local anesthetic is injected to produce separation between the two muscle.

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
Single (Outcomes Assessor)

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients scheduled for open abdominal cancer surgery.
  • •American Society of Anesthesiologists physical status grade I and grade II.

排除标准

  • •Patient refusal.
  • •Neuromuscular diseases (as myopathies, myasthenia gravies, ......)
  • •Hematological diseases, bleeding or coagulation abnormality.
  • •Psychiatric diseases.
  • •Local skin infection and sepsis at site of the block.
  • •Known intolerance to the study drugs.
  • •Body Mass Index > 40 Kg/m

研究组 & 干预措施

Quadratus lumborum block Group

Experimental

ultrasound guided

干预措施: Quadratus lumborum block (Other)

Transversus abdominis plane block Group

Active Comparator

ultrasound guided

干预措施: Transversus abdominis plane block (Other)

结局指标

主要结局

The total dose of morphine consumption

时间窗: postoperative: in the first 24-hour

milligram

次要结局

  • the time to the first analgesic requirement(postoperative: in the first 24-hour)
  • pain intensity by visual analogue scale (VAS)(postoperatively, at 0, 2, 4, 8, 16 and 24 hours)
  • sedation score by Modified Ramsay sedation score(postoperative, at 0, 2, 4, 8, 16 and 24 hours)
  • postoperative nausea, vomiting(postoperative in the first 24 hours)
  • Mean blood pressure(intraoperatively every 30 minutes, then at 0, 2, 4, 8,16 and 24 hours postoperatively.)
  • Heart rate(intraoperatively every 30 minutes, then at 0, 2, 4, 8,16 and 24 hours postoperatively.)

研究者

发起方
Alaa Mazy
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Alaa Mazy

Associate professor of anesthesia and surgical intensive care

Mansoura University

研究点 (1)

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