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临床试验/NCT06981728
NCT06981728尚未招募不适用

Ultrasound-Guided Mid-Point Transverse Process to Pleura Block Versus Thoracic Paravertebral Block for Pain Management in Patients With Multiple Rib Fractures (A Prospective Randomized Double- Blinded, Non-inferiority Trial )

Assiut University0 个研究点目标入组 70 人开始时间: 2025年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
70
主要终点
The primary outcome will be the mean difference in numeric rating pain scores (NRS) between the MTPB and TPVB groups at 24-hour after the block.

研究概览

简要总结

The aim of our study is to investigate whether the analgesic effect of MTPB is non inferior to that of TPVB in trauma patients with multiple rib fractures.

详细描述

Trauma is a major global health problem. In Egypt, trauma-related death accounted for 8% of total fatalities and was the eighth leading cause of death in 2010. However.[1]Rib fractures have an incidence around 10% of all trauma patients and over 30% of chest trauma patients.[2] Multiple fractured ribs are associated with extreme pain, to avoid intensifying discomfort, patients' breathing becomes shallower and they repress coughing, leading to respiratory insufficiency. Which may result in numerous complications, as sputum retention, atelectasis, infection, and respiratory insufficiency. This is associated with increase in intensive care admissions and mortality (25%).[3] Hence, pain control is the cornerstone of rib fracture management. Modalities for pain relief ranges from oral administration of analgesic drugs to regional nerve blocks including [intrapleural, intercostal ,thoracic paravertebral nerve blockade (TPVB)]. Despite the low rate of technical failure in TPVB execution (6.1%), pulmonary complications, such as inadvertent pleural puncture (0.8%) and pneumothorax (0.5%), are still a recognized risk.[4] Bedside ED-performed ultrasound-guided anesthesia is gaining in popularity, and early and adequate pain control has shown improved patient outcomes with rare complications.

One of the most recently described technique is mid-point transverse process to pleura (MTP) block.[2] In MTP block, the local anesthetic drug is deposited at the mid-point between the transverse process and pleura and it reaches the paravertebral space by diffusion. With this technique, even if superior costotransverse ligament (SCTL) is not visible, effective block can be achieved. In addition, needle is placed far away from pleura minimizing the rate of pneumothorax.[5]

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)

盲法说明

According to computer-generated software randomization (www.randomization.com) table into two groups of 35 each, patients randomly were allocated to Group M or Group P at a ratio of 1:1.

  • Group M: mid-point transverse to pleura block.
  • Group P: thoracic paravertebral block. The grouping sequence was put into a sealed opaque envelope, the operator opened the envelope to identify the type of block. Patients were blinded to the grouping assignments. After trial completion, all participants remained unaware of the grouping assignments until un blinding.

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Adult patients aged between 18 and 70 years, from both genders, who had uni lateral traumatic multiple rib fractures (three or more confirmed by a CT chest scan).

排除标准

  • •Significant head injury/unconsciousness (GCS less than 15).
  • •Patients with Pain score >
  • •those 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.
  • •Obese patients with body mass index ≥
  • •coagulopathy.
  • •History of drug allergy to local anesthetics.
  • •Patient refusal.
  • •Local infection at the injection site.
  • •Opioid addiction.

研究组 & 干预措施

M (MTPB)

Active Comparator

Mid-point transverse to pleura block

干预措施: Mid point transverse to pleura block (Procedure)

P (TPVB)

Sham Comparator

Thoracic paravertebral block

干预措施: Mid point transverse to pleura block (Procedure)

结局指标

主要结局

The primary outcome will be the mean difference in numeric rating pain scores (NRS) between the MTPB and TPVB groups at 24-hour after the block.

时间窗: 24hour

次要结局

  • • NRS scores at different times up to 24 hours.(72hour)
  • Time for first analgesic request. • Total 24 hours analgesic consumption.(24hour)
  • • Total 24 hours analgesic consumption.(24hour)
  • • Time for block performance.(30min)
  • • Dermatomal block effect.(24hour)
  • inspiratory volumes (mL) measured with a volume incentive spirometer.(72hour)
  • respiratory rate (RR),Heart rate (HR), Blood Pressure (BP), peripheral oxygen saturation (SpO2),and need for mechanical ventilation.(3 days)
  • • Complications such as pneumothorax bradycardia hypotension. • development of pneumonia, hospital length of stay, and mortality.(3days)

研究者

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

Aya Yassien Mahmoud Ahmed

MD doctor

Assiut University

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