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临床试验/NCT03797079
NCT03797079已完成不适用

Erector Spinae Plane Block Versus Thoracic Epidural Block as Analgesic Techniques for Chest Trauma

Sameh Fathy1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2019年1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
状态
已完成
发起方
Sameh Fathy
入组人数
50
试验地点
1
主要终点
Improvement in pain scores by Visual analogue scale (VAS)

研究概览

简要总结

Rib fractures are very common as a consequence of blunt chest trauma which is associated with severe pain, morbidity and mortality. The key to managing these patients is prompt and effective analgesia, early mobilization, respiratory support, with chest physiotherapy. The aim of this study is to compare and evaluate the differences between either continuous erector spinae plane (ESP) block, or thoracic epidural analgesia (TEA) as analgesic modalities in patients with chest trauma. It is hypothesized that ESP block will be comparable to TEA as a promising effective analgesic alternative with fewer side effects.

详细描述

Trauma is a major cause of morbidity and mortality worldwide as a leading cause of death. Rib fractures are very common and are detected in at least 10% of all injured patients, the majority of which are as a consequence of blunt chest trauma. Chest trauma are associated with severe pain, morbidity and mortality, as it contributes to atelectasis, lobar collapse, pneumonia, effusion, aspiration, acute respiratory distress syndrome pulmonary embolism, increased intensive care admissions, and poor overall clinical outcomes. Trauma is associated with release of cytokines, which contribute to the development of hemodynamic instability and metabolic derangement, which can worsen prognosis. The efficacy of utilizing different modalities for analgesia in controlling extent of tissue damage can be compared by measuring these cytokines levels. Multiple analgesic modalities have been used in these patients with chest trauma, such as oral analgesics, intravenous opioids, patient-controlled opioid analgesia, inter-pleural blocks, intercostal blocks, serratus plane blocks, paravertebral blocks, and TEA. In trauma patients with rib fractures, retrospective studies showed that TEA has become the gold standard of care, while ultrasound-guided paravertebral and serratus plane blocks are possible alternatives. However, no single best analgesic modality could be recommended or established, based on available data in this population, as no meta-analysis on this topic has yet been completed. Ultrasound has been the fundamental tool for a significant improvement in the progress of regional analgesic techniques of inter-fascial chest wall blocks, allowing their description and introduction into clinical practice. Ultrasound-guided ESP block is a new technique that has been recently described in the control of both chronic neuropathic pain as well as acute postsurgical or post-traumatic pain of the chest wall. The ESP block holds promise as a simple, easy, fast and safe technique for thoracic analgesia in the context of pain associated with chest trauma.

Aim of the Study:

The aim of this study is to assess the quality of pain relief and improvement of pulmonary function in patients with chest trauma receiving either continuous ESP block or TEA by comparing and evaluating the differences between the two techniques. It is hypothesized that ESP block will be comparable to TEA as a promising effective analgesic alternative with fewer side effects.

Sample Size Calculation:

The literature available on ESP block is limited to some sporadic case reports and editorials. Hence, this clinical trial will be conducted on 50 patients and post hoc analysis will be performed using pain scores obtained from the present study with an α (type I error) = 0.05 and β (type II error) = 0.2 (power = 80%).

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)

盲法说明

The study subjects and the resident assessing the outcomes will be blinded to the study group. A single investigator will assess the patients for eligibility, obtain written informed consent, open the sealed opaque envelopes containing group allocation, perform the block, and administer bupivacaine solution.

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

  • American Society of Anesthesiologists (ASA) status: 1 or 2 .
  • Blunt chest trauma.
  • Multiple rib fractures.
  • Flail chest.
  • Lung contusions.

排除标准

  • Bilateral chest trauma.
  • Intubated patients.
  • Other peripheral or abdominal injuries.
  • Traumatic brain injury, altered mental status or un-cooperative patients.
  • Acute spine fractures or pre-existing spine deformity.
  • Unstable hemodynamics.
  • Sensitivity to local anesthetic drugs.
  • Coagulation abnormalities.
  • Infection at the site of procedure.
  • Significant cardiac or respiratory dysfunction, hepatic or renal impairment.

研究组 & 干预措施

Group B (TEA)

Active Comparator

TEA will be performed under strict aseptic precautions with patient in the sitting position. Catheter insertion will be performed and bupivacaine will be administered.

干预措施: Catheter insertion (Device)

Group A (ESP block)

Active Comparator

Ultrasound-guided ESP block will be performed under strict aseptic precautions with patient in the sitting position. Catheter insertion will be performed and bupivacaine will be administered.

干预措施: ESP block (Procedure)

Group A (ESP block)

Active Comparator

Ultrasound-guided ESP block will be performed under strict aseptic precautions with patient in the sitting position. Catheter insertion will be performed and bupivacaine will be administered.

干预措施: Catheter insertion (Device)

Group A (ESP block)

Active Comparator

Ultrasound-guided ESP block will be performed under strict aseptic precautions with patient in the sitting position. Catheter insertion will be performed and bupivacaine will be administered.

干预措施: Bupivacaine (Drug)

Group B (TEA)

Active Comparator

TEA will be performed under strict aseptic precautions with patient in the sitting position. Catheter insertion will be performed and bupivacaine will be administered.

干预措施: TEA (Procedure)

Group B (TEA)

Active Comparator

TEA will be performed under strict aseptic precautions with patient in the sitting position. Catheter insertion will be performed and bupivacaine will be administered.

干预措施: Bupivacaine (Drug)

结局指标

主要结局

Improvement in pain scores by Visual analogue scale (VAS)

时间窗: Up to 48 hours after the procedure

VAS score from 0 to 10 (0 = no pain and 10 = the worst imaginable pain) will be assessed every two hours for 48 hours after the procedure.

次要结局

  • Improvement in forced expiratory volume in one second (FEV1)(Up to 48 hours after the procedure)
  • Improvement in the level of tumor necrosis factor alpha (TNF-α)(Up to 48 hours after the procedure)
  • Incidence of adverse effects(Up to 48 hours after the procedure)
  • Total analgesic requirements of fentanyl(Up to 48 hours after the procedure)
  • First analgesic request(Up to 48 hours after the procedure)
  • Improvement in the level of interleukin 6 (IL-6)(Up to 48 hours after the procedure)
  • Changes in mean arterial blood pressure (MAP)(Up to 48 hours after the procedure)
  • Improvement in forced expiratory flow (FEF 25-75%)(Up to 48 hours after the procedure)
  • Changes in heart rate (HR)(Up to 48 hours after the procedure)
  • Improvement in forced vital capacity (FVC)(Up to 48 hours after the procedure)

研究者

发起方
Sameh Fathy
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Sameh Fathy

Lecturer of anesthesia, ICU & pain management; Faculty of Medicine

Mansoura University

研究点 (1)

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