跳至主要内容
临床试验/NCT03214536
NCT03214536已完成不适用

Erector Spine Block in Patients Undergoing Back Surgery, Observational Feasibility Trial of the Effect on Postoperative Pain-scores and Opioid Consumption

University Hospital, Antwerp2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2017年6月25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
状态
已完成
入组人数
15
试验地点
2
主要终点
24 hour opioid consumption

研究概览

简要总结

In spine surgery postoperative pain can often be severe and difficult to treat.With the use of ultrasound, the performance of plane blocks and other techniques like root blocks, facet infiltration have become possible without the use of either unreliable " pop-techniques" or the use of x-ray.The erector spinae block was recently described as a safe and simple and safe technique for neuropathic pain and acute post surgical pain, with effect on the dorsal rami of the spinal nerves and with promising results. In this observational pilot study we want to test the influence of these to blocks on the postoperative pain and opioid consumption after spine fusion.

详细描述

In 10-15 patients undergoing back surgery (laminectomy or back surgery with lumbar pedicle screw placement or revision back surgery), will be asked to give informed consent to receive a bilateral lumbar erector spinae block before surgery. In this population it will be clear after 10-15 patients if there is a beneficial effect since these patients normally require a substantial amount of postoperative opioids because of significant postoperative pain.

The blocks will be performed by experts in the field of ultrasound guided locoregional anaesthesia in a separate block room with ultrasound after placement of an iv line and application of standard monitoring (ECG, NIBP, saturation)

Description of block performance according to Chinn et al but at a lumbar level:

The patient will be placed in the lateral or sitting position. With a curve array probe or a high frequency linear probe, depending on the BMI of the patient, will be placed in a longitudinal position 2-3 cm lateral of the vertebral column. The transverse processes of the vertebrae at the (mid) level of surgery, the erector spinae muscle and the psoas muscle are identified. Depending on the depth a 5 or 8 cm 22 G ultrasound needle (pajunk) will be inserted in an in plane technique in a cephalad to caudad direction until bone contact with the top of the transverse process is reached. After slight retraction of the needle, 20 ml of ropivacaine 0,375% will be injected behind the erector spinae muscle. The same procedure will be repeated on the contralateral side.

Sensory loss of the posterior dermatomes and dermatomes of the anterior roots of the spinal nerves (lumbar plexus, upper leg) will be tested Motor function of the legs will be evaluated with a Bromage (0-3) score.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients planned for laminectomy or back surgery with lumbar pedicle screw placement or revision back surgery

排除标准

  • patient refusal, bleeding disorder, infection

研究组 & 干预措施

erector spinae block

Experimental

bilateral erector spine block with 20 ml 0,375% ropivacaine

干预措施: erector spinae block (Procedure)

erector spinae block

Experimental

bilateral erector spine block with 20 ml 0,375% ropivacaine

干预措施: Ropivacaine (Drug)

erector spinae block

Experimental

bilateral erector spine block with 20 ml 0,375% ropivacaine

干预措施: Spine surgery (Procedure)

erector spinae block

Experimental

bilateral erector spine block with 20 ml 0,375% ropivacaine

干预措施: anesthesia (Procedure)

结局指标

主要结局

24 hour opioid consumption

时间窗: 24 hours from injection ( T0)

cumulative opioid consumption first 24 hours after block performance

次要结局

  • sensory block(30 minutes after block performance)
  • motor block(30 minutes after block performance)
  • pain scores(24 postoperative at regular intervals)

研究者

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

Dr M. B. Breebaart

principal investigator

University Hospital, Antwerp

研究点 (2)

Loading locations...

相似试验