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临床试验/NCT07404995
NCT07404995已完成不适用

Analgesic Efficacy of Bilateral Erector Spinae Plane Block in Pediatric Tethered Cord Syndrome Surgery: A Prospective, Randomized Controlled Trial

Bursa Yuksek Ihtisas Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 73 人开始时间: 2025年4月9日最近更新:
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
73
试验地点
1
主要终点
INTRAOPERATİVE ANESTHETİC DRUG CONSUMPTİON BY APPLYİNG BİLATERAL ESPB İN PEDİATRİC PATİENTS.

研究概览

简要总结

Tethered Cord Syndrome is a developmental anomaly of neuroaxis characterized by stretching of the spinal cord and is diagnosed in the pediatric age group. Surgical release of the tight and tethered filum terminale is performed. Intraoperative neurophysiological monitoring (IONM) is used to preserve functional nerve tissue and prevent postoperative neurological deficits. Total intravenous anesthesia (TIVA-TCI) with propofol and remifentanil is used as the anesthesia method to ensure accurate measurements. Postoperative pain is acute pain caused by surgical trauma and signal transmission in afferent neurons. Pediatric postoperative pain is associated with adverse behaviors, prolonged hospital stay, and impaired functional recovery. Although good progress has been made in pain management, ineffective postoperative pain management in children remains a global problem. Regional anesthesia is increasingly used in pediatric patients to provide postoperative analgesia and support intraoperative anesthesia. Ultrasound-guided erector spinae plane block (ESPB) is a new approach. First introduced in 2016 by Forero et al., ESPB is a novel regional anesthesia technique that blocks the branches of spinal nerves by injecting a local anesthetic into the fascial plane between the erector spinae muscle and the transverse process. The aim of our study was to reduce intraoperative anesthetic drug consumption, postoperative pain levels in the first 24 hours, the need for analgesics, and unwanted side effects associated with analgesics by applying bilateral ESPB in pediatric patients operated on for Tethered Cord Syndrome. Our hypothesis in this study is that bilateral ESPB reduces intraoperative anesthetic drug consumption and the need for postoperative analgesia in pediatric patients operated on for Tethered Cord Syndrome.

详细描述

Ultrasound-guided erector spinae plane block (ESPB) that aims for the ventral and dorsal rami of the spinal nerves was recently introduced in spine surgery to treat postoperative pain. ESPB was reported to be effective in scoliosis surgery as it reduced the need for analgesic drugs. Due to its relative technical simplicity, the main advantages postulated for the ESPB are few complications and minimal risk for spinal cord injury.

研究设计

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

入排标准

年龄范围
1 Year 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patients whose parents have given their consent to the study
  • Patients aged 18 and under
  • Patients with ASA (American Society of Anesthesiologists) physical status I, II, and III
  • Pediatric patients who will undergo elective Tethered Cord Syndrome surgery

排除标准

  • Patients whose parents did not consent to participate in the study
  • Patients with ASA physical status IV and V
  • Those using anticoagulant medications
  • Allergy to local anesthetic drugs
  • Patients with a history of gastrointestinal bleeding
  • Those with infection in the area where the block is planned

研究组 & 干预措施

UNDER ULTRASOUND GUİDANCE ESPB GROUP

Experimental

Under ultrasound guidance, bilateral erector spinae plane block will be performed on the ESPB group one level above the appropriate area for pediatric tethered cord surgery using the anesthetic drug bupivacaine.

干预措施: UNDER ULTRASOUND GUİDANCE ESPB BLOCK (Device)

UNDER ULTRASOUND GUİDANCE ESPB GROUP

Experimental

Under ultrasound guidance, bilateral erector spinae plane block will be performed on the ESPB group one level above the appropriate area for pediatric tethered cord surgery using the anesthetic drug bupivacaine.

干预措施: PROCEDURE/SURGERY: ERECTOR SPİNAE (ESP) BLOCK WİTH BUPİVACAİNE (Procedure)

结局指标

主要结局

INTRAOPERATİVE ANESTHETİC DRUG CONSUMPTİON BY APPLYİNG BİLATERAL ESPB İN PEDİATRİC PATİENTS.

时间窗: İNTRAOPERATİVE

TOTAL PROPOFOL (MİLLİGRAM) and TOTAL REMİFENTANYL (MİCROGRAM)

次要结局

  • POSTOPERATIVE PAIN SCORES(POSTOPERATIVE SERVICE 0. MINUTE 30.MINUTE 12.HOURS 5. MINUTE 1. HOURS 24. HOURS 10. MINUTE 2.HOURS 15. MINUTE 4. HOURS 20. MINUTE 6.HOURS)

研究者

发起方
Bursa Yuksek Ihtisas Training and Research Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

sermın emınoglu

ASSOCIATE PROFESSOR

Bursa Yuksek Ihtisas Training and Research Hospital

研究点 (1)

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