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临床试验/NCT03790566
NCT03790566Unknown不适用

Comparison of Erector Spinae Plane Block With Transversus Abdominus Plane Block for Peri-operative Pain Management in Pediatric Open Pyeloplasty Cases

Istanbul University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年2月20日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
40
试验地点
1
主要终点
Remifentanil need

研究概览

简要总结

Regional anesthesia decreases the need for intravenous analgesia in the peri-operative period. Erector spinae plane (ESP) and transversus abdominus plane (TAP) blocks are two common regional anesthesia techniques shown to be effective in open abdominal surgeries. We aim to compare effectiveness of ESP block with TAP block for peri-operative analgesia in pediatric open pyeloplasty patients with a flank incision.

详细描述

Regional anesthesia for effective post-operative pain management is a part of the pediatric Enhanced Recovery After Surgery (ERAS) protocol. Epidural anesthesia is the gold standard for analgesia for open abdominal surgeries, however difficulties in application and possible complications deter clinicians from utilizing this method. Safe and effective alternatives to epidural anesthesia has been a critical and popular focus of clinical research in recent years. Transversus abdominus plane (TAP) block is an alternative technique shown to be effective in pediatric open abdominal surgeries.

Erector spinae plane (ESP) block was described as an effective block for multi-dermatome pain after thoracic surgery. It is emerging as a safe and easy-to-perform alternative to epidural anesthesia for pelvic, abdominal and thoracic surgery.

During an open pyeloplasty, the flank incision goes through the transversus abdominus plane, where the local anesthetic is injected for TAP block. This may weaken the analgesic effect of the block. In the ESP block, local anesthetic diffuses cranio-caudally through the fascia of erector spinae muscles and the flank incision does not disturb this plane. We aim to compare the effectiveness of ESP block with TAP block in open pyeloplasty patients.

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
Single (Outcomes Assessor)

入排标准

年龄范围
1 Year 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • American Society of Anesthesiologist class I, II or III
  • Patients scheduled for elective open pyeloplasty surgery

排除标准

  • Local anesthetic allergy or other contraindication to local anesthetic use
  • Coagulation disorders
  • History of chronic pain
  • Patient/Family refusal
  • History of scoliosis, spinae bifida, abdominal wall defect
  • Past surgical procedures with abdominal wall incision
  • Plan to extend the flank incision for additional surgical intervention

研究组 & 干预措施

Erector spinae plane block

Experimental

With the patient in lateral decubitus position (surgical side up), the transverse processes of T10-T12 vertebrae and erector spinae (ES) fascia are visualized 1-2 cm lateral to the vertebral spine using a linear ultrasound probe. A 22G peripheral block needle is introduced with in-plane technique under the ES muscle and local anesthetic solution (0.5 ml/kg 0.25% bupivacaine) is injected in this plane after a test injection with 0.5 ml of 0.9% NaCl solution to visualize opening of ESP.

干预措施: Bupivacaine (Drug)

Transversus abdominus plane block

Active Comparator

With the patient in supine position, three layers of abdominal muscle are visualized using the linear ultrasound probe held with the long axis on the mid-axillary line above the iliac crest. 22G peripheral block needle is introduced in-plane into the fascia between the internal oblique and transversus abdominus muscles and local anesthetic solution (0.5 ml/kg 0.25% bupivacaine) is injected in this plane after a test injection with 0.5 ml of 0.9% NaCl solution to visualize opening of ESP.

干预措施: Bupivacaine (Drug)

结局指标

主要结局

Remifentanil need

时间窗: During the operation

Intraoperative remifentanil requirement as rescue analgesia

Post-operative analgesia need

时间窗: 24 hours post-operatively

Pain score is assessed with FLACC (Face, Legs, Activity, Cry, Consolability) scale. A score of 2, 3, 4 or 5 warrants for intravenous paracetamol need and a score of 6 and above warrants for intravenous tramadol

次要结局

  • Parental satisfaction with analgesia(24 hours post-operatively)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

pinar kendigelen

Assoc. Prof.

Istanbul University

研究点 (1)

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