跳至主要内容
临床试验/NCT03883958
NCT03883958Unknown不适用

Comparison of Thoracic Erector Spinae Plane Block With Thoracic Paravertebral Block for Pain Management in Patients With Unilateral Multiple Fractured Ribs

Assiut University0 个研究点目标入组 60 人开始时间: 2019年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
60
主要终点
Change in visual pain score

研究概览

简要总结

Rib fractures pose a significant healthcare burden with its associated morbidity, long term disability, and mortality. Pulmonary morbidity is increased in these patients as a result of diminished gas exchange from fracture induced pulmonary injury and from inadequate analgesia compromising both ventilation and pulmonary mechanics. Adequate analgesia is paramount in enhancing pulmonary hygiene aimed at preventing atelectasis and pneumonia. Numbing the nerves to the fractured ribs by injecting local anaesthetic (LA) improves breathing and reduces the risk of complications. Two techniques of regional anesthesia (erector spinae plane block (ESPB) and paravertebral block (PVB)) will be compared regarding their efficacy for treating pain caused by rib fractures. The LA is injected near nerves at two different locations. The PVB is immediately adjacent to the vertebrae, whereas the ESPB is slightly further away from the midline. Both techniques use ultrasound to ensure the LA is directed to the intended place. Adult patients with > 3 consecutive fractured ribs will be consented, then randomised to receive either a ESPB or a PVB. It is expected that both groups will significantly improve in terms of pain score, opioids need, and breathing ability, however it is unclear which technique will provide better results and less complications.

详细描述

Rib fractures occur most commonly because of blunt thoracic trauma and occur in up to 12% of all trauma patients. Rib fractures themselves pose a significant healthcare burden with its associated morbidity, long term disability, and mortality. Pulmonary morbidity is increased in these patients as a result of diminished gas exchange from fracture induced pulmonary injury and from inadequate analgesia compromising both ventilation and pulmonary mechanics. Various factors affect outcome and mortality after rib fractures. These include the number of ribs fractured, preexisting comorbidities, advanced age, and level of associated pain. Of these, pain is a significant modifiable factor.

Adequate analgesia is paramount in enhancing pulmonary hygiene aimed at preventing atelectasis and pneumonia. Systemic analgesia is usually sufficient in younger patients with fewer undisplaced fractures without a flail segment. Regional techniques are particularly useful in elderly patients (>65 years of age), patients with multiple rib fractures (MRFs), and in patients with severe pain or compromised pulmonary function. Conventional regional techniques used to manage rib fractures include epidural analgesia, paravertebral block (PVB), intercostal, and intrapleural block.

In 2010 Truitt et al. introduced a novel technique whereby local anesthetic (LA) infiltration superficial to the posterior ribs via tunneled catheters successfully controlled rib fracture pain. Since then, multiple thoracic RA (Regional Anesthesia) techniques have been developed that use ultrasound-guided (USG) LA (local anesthetic) injections into fascial planes from the thoracic spinal lamina to the sternum to anesthetize various regions of the thorax.

Some of the conventional regional techniques, particularly epidural analgesia and PVB, may not be feasible in the presence of anticoagulation, multisystem trauma, or in patients unable to be optimally positioned. Recently, several ultrasound-guided (USG) myofascial plane blocks (both single injection and continuous catheter techniques) have been described (e.g. The serratus anterior plane (SAP) block and the erector spinae plane (ESP) block) , which offer the advantages of being less invasive technique and provide adequate analgesia after rib fractures.

ESP block is a novel myofascial plane block recently introduced into clinical practice. It has been successfully utilized in the management of pain after both rib fractures and surgery of the abdomen and thorax, and in the management of chronic thoracic pain. In contrast to the SAP block, the ESP block has the ability to provide analgesia to both the anterior and posterior hemithorax, making it particularly useful in the management of pain after extensive thoracic surgery or trauma (anterior, lateral, and posterior chest wall). Innervation of the ribs and adjoining tissue is primarily through thoracic spinal nerves. After emerging from the spinal cord and traversing through the intervertebral foramina, the thoracic spinal nerves split into ventral and dorsal rami. The ventral rami continue as intercostal nerves innervating the lateral and anterior chest wall, whereas the dorsal rami innervate the posterior chest wall after exiting the paravertebral space.

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, Investigator, Outcomes Assessor)

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

  • All patients aged 18 years old or more.
  • Rib Fracture Score 7 or more.
  • American Society of Anesthesiologist's physiologic state II-III patients.
  • 3-6 consecutive fractured ribs.

排除标准

  • Patients who are unable to communicate effectively.
  • Sternal fractures.
  • Bilateral rib fractures.
  • VAS score <
  • Preexisting spinal deformity.
  • Local sepsis at site of injection.
  • Coagulopathy.
  • Known allergy to the local anesthetic used in the study.
  • Patients having significant trauma outside the chest wall e.g., acute spine or pelvic fracture, severe traumatic brain or spinal cord injury, or abdominal visceral injuries.

研究组 & 干预措施

TPVB

Active Comparator

干预措施: Paravertebral Block (Procedure)

ESPB

Experimental

干预措施: Erector Spinae Plane Block (Procedure)

结局指标

主要结局

Change in visual pain score

时间窗: Immediatly before and after intervention, 30 minutes after intervention, 3 hours after intervention, 6 hours after intervention and 24 hours after intervention

0 meaning no pain at all, and 10 described as the worst pain experienced.

Change in Diaphragmatic excursion

时间窗: Immediatly before and after intervention, 30 minutes after intervention, 3 hours after intervention, 6 hours after intervention and 24 hours after intervention.

Normal diaphragmatic excursion should be 3-5 cm, but can be increased in well-conditioned persons to 7-8 cm. This measures the contraction of the diaphragm. It is performed by asking the patient to exhale and hold it. The provider then percusses down their back in the intercostal margins (bone will be dull), starting below the scapula, until sounds change from resonant to dull (lungs are resonant, solid organs should be dull). That is where the provider marks the spot. Then the patient takes a deep breath in and holds it as the provider percusses down again, marking the spot where the sound changes from resonant to dull again. Then the provider will measure the distance between the two spots.

次要结局

  • Opioid dose used for 24-hour period after the procedure.(24 hour after intervention)

研究者

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

Mohamed Abdelhamid Youssef Ahmed

Principal Investigator

Assiut University

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