跳至主要内容
临床试验/NCT06231979
NCT06231979尚未招募4 期

Effects of Adding Dexmedetomidine to Bupivacaine for Bilateral Erector Spinae Block in Lumbar Fusion Surgeries

Assiut University0 个研究点目标入组 48 人开始时间: 2024年2月25日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
尚未招募
入组人数
48
主要终点
the cummulative opioid consumption during first 48 h postoperatively.

研究概览

简要总结

The aim of this study is to compare the analgesic effect of bilateral US-guided ESPB using bupivacaine alone versus bupivacaine and DEX in lumbar fusion surgeries.

详细描述

Surgical treatment of adult lumbar spinal disorders is associated with a substantial risk of perioperative complications. The improvement in management and the development of new techniques in anesthesia and surgical sciences have led to substantial reduction of complications related to lumbar spine surgeries.

Understanding these complications is important and valuable for both the patient and the surgeon. Nevertheless, complications represent undesirable consequences of lumbar spine surgery in adult patients.

Degenerative lumbar disease is one of the most common chronic diseases worldwide. The general incidence of lumbar stenosis accompanied by a significant deterioration in the quality of life reaches 5 % among patients aged < 50 years and approximately 10 - 15 % among elderly patients (50 - 70 years old) Moreover, lumbar stenosis appears to be one of the most common causes of decompression and fusion interventions in the lumbar spine in > 50 years old patients Lumbar surgeries refer to any type of surgical intervention involving any lumbar spine or lower back (between one or more of the L1 - S1 level), including operations for trauma and deformity. The complexity of procedures leads to an increase in comorbidities Major lumbar spine surgery causes severe postoperative pain, which typically persists for at least three days Risk factors most frequently associated with mortality include but are not limited to patients' age, sex, and comorbidity status Postoperative pain is one of the most troublesome pains for the surgical patients and is one of the causes of morbidity and prolonged hospital stay. Various studies have reported that maximal pain occurs in the first 4 postoperative hours and gradually declines by the third postoperative day .

Opiates and non-steroidal anti-inflammatory drugs have been routinely used across the world. Recent resurge of regional anesthetic techniques offer some advantages, especially reduced postoperative nausea and vomiting and less sedation .

Ultrasound (US)-guided erector spinae plane blockade (ESPB) was first developed by Forero in 2016 as an easy and safe way of managing thoracic neuropathic pain. Since that time, this block has gained in popularity and has been used to effectively provide analgesia for a variety of surgeries, including spine surgery .

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients of both genders
  • age between 18-65 years
  • American Society of Anesthesiologists (ASA) physical status I-II**
  • scheduled for lumbar spine fusion surgeries ( 2 or 3 level lumbar fusion with or without decompression ) under general anesthesia .

排除标准

  • Patient refusal.
  • Patient with chronic use of opioid analgesia.
  • Uncooperative patients with communication difficulties, which might prevent a reliable postoperative assessment.
  • Contraindication to regional anesthesia (bleeding disorder, use of any anticoagulants, local infection).
  • Known allergy to local anesthetics.

研究组 & 干预措施

Dexmedetomidine group

Experimental

Patients will receive US-guided ESPB with 18 mL of bupivacaine 0.25 % and 1 μg/kg DEX diluted with saline to reach total volume 20 mL per side.

干预措施: Dexmedetomidine (Drug)

Dexmedetomidine group

Experimental

Patients will receive US-guided ESPB with 18 mL of bupivacaine 0.25 % and 1 μg/kg DEX diluted with saline to reach total volume 20 mL per side.

干预措施: Bupivacain (Drug)

Bupivacaine group

Experimental

Patients will receive US-guided ESPB with 18 mL of bupivacaine 0.25 % and 2 mL normal saline 0.9 % per side as control group.

干预措施: Bupivacain (Drug)

Bupivacaine group

Experimental

Patients will receive US-guided ESPB with 18 mL of bupivacaine 0.25 % and 2 mL normal saline 0.9 % per side as control group.

干预措施: Normal saline (Drug)

结局指标

主要结局

the cummulative opioid consumption during first 48 h postoperatively.

时间窗: 48 hours postoperatively.

次要结局

  • Change in stress marker Super Oxide Dismutase (SOD) .(24 hours postoperative.)
  • Postoperative pain score using Visual Analogue Scale (VAS).(immediately postoperative)

研究者

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

Mohammed Ali Hassan Refaat AL-Quossi

assistent lecture

Assiut University

相似试验

Adding Dexmedetomidine to Bupivacaine for Bilateral... | 临床试验