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临床试验/NCT06088836
NCT06088836已完成不适用

Impact of Ultrasound- Guided Continuous Retro Laminar Block Versus Continuous Erector Spinae Plane Block on Incentive Spirometry Volumes and Pain Scores in Multiple Rib Fractures

Tanta University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年10月18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
60
试验地点
1
主要终点
Maximum inspired volume

研究概览

简要总结

The aim of this study is to compare the incentive spirometry volume and analgesic efficacy of ultrasound guided continuous Retrolaminar block and continuous Erector spinae plain block in patients with multiple rib fractures.

详细描述

Thoracic epidural analgesia (TEA) and thoracic paravertebral block (TPVB) are strongly recommended techniques for managing thoracic neuropathic pain However, they can be technically challenging to perform and are associated with up to 15% failure rate in Thoracic epidural analgesia (TEA)and potential risk of pneumothorax in thoracic paravertebral block (TPVB).Newer approaches have been the focus of many studies in recent years; these approaches include retrolaminar block and erector spinae plane block.

Retrolaminar block (RLB) is a new thoracic truncal block for controlling somatic pain in both the thoracic and abdominal walls.

The Erector Spinae plane block (ESPB) has been used successfully to manage severe neuropathic pain arising from ribs .The basis to use ESPB is its likely site of action which is the dorsal and ventral rami of the thoracic spinal nerves.

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
Double (Participant, Outcomes Assessor)

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

  • Age from 18 to 65 years old.
  • Both sexes.
  • Patients with unilateral multiple traumatic rib fractures (≥ 3 ribs).

排除标准

  • 1st ken refusal.
  • Patients with any contraindication for regional block as:
  • Bleeding disorders.
  • Infection at the injection site.
  • Patients with hemodynamic instability.
  • Patients with known hypersensitivity to the study drugs
  • Unconscious patients
  • Patients with significant trauma outside the chest wall e.g., acute spine or pelvic fracture, severe traumatic brain or spinal cord injury, or abdominal visceral injuries
  • Patients with significant lung contusions, pneumothorax, flail chest
  • Chronic opioid users.
  • Uncooperative patients and patients with psychiatric illness

研究组 & 干预措施

Group I (Retrolaminar block group)

Experimental

Patients received ultrasound guided Retrolaminar block bolus dose of 20 ml 0.25% bupivacaine then continuous infusion at a rate of 0.1 mL/kg/hr. for 4 days

干预措施: Retrolaminar block group (Drug)

Group II (Erector spinae plane block group)

Experimental

Patients received ultrasound guided Erector spinae plane block bolus dose of 20 ml 0.25% bupivacaine then continuous infusion at a rate of 0.1 mL/kg/hr. for 4 days

干预措施: Erector spinae plane block group. (Drug)

结局指标

主要结局

Maximum inspired volume

时间窗: 4 days after intervention.

Maximum inspired volume will be measure by incentive spirometry which indicate less pain. Inspiratory capacity (IC) measured by Incentive Spirometry before the block, 30 minutes, 60 minutes after the blocks and then every six hours for subsequent 4 days.

次要结局

  • Respiratory rate(4 days after intervention.)
  • Intensive care length of stay.(28 days after intervention)
  • Adverse effects and complications.(4 days after intervention.)
  • Hospital length of stay.(28 days after intervention)
  • Daily and total rescue analgesics consumption.(24 hours after intervention.)
  • PaO2(4 days after intervention.)
  • pH(4 days after intervention.)
  • PaCo2(4 days after intervention.)
  • FiO2(4 days after intervention.)

研究者

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

Hossam Ibrahim Elsayed Ibrahim

Assistant Lecturer of Anesthesia, Surgical ICU and Pain Medicine Master's degree of Anesthesia, Surgical ICU And Pain Medicine

Tanta University

研究点 (1)

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