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临床试验/NCT05965895
NCT05965895招募中4 期

Ultrasound-Guided Continuous Serratus Anterior Plane Block Versus Intravenous Dexmedetomidine Infusion for Pain Control in Patients With Multiple Rib Fractures: A Prospective Randomized Clinical Trial.

Beni-Suef University1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2023年8月1日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
招募中
入组人数
150
试验地点
1
主要终点
Quality of analgesia measured by visual analogue scale

研究概览

简要总结

The aim of this work is to compare analgesic efficacy in patients with multiple rib fractures who will be managed with Ultrasound-guided continuous serratus anterior plane block versus patients who will be managed with dexmedetomidine infusion.

详细描述

In thoracic trauma patients with rib fractures, the ability to cough and clear secretions is impaired by pain, leading to an increased risk of atelectasis, retention of secretions, chest infections and prolonged ICU stay thereby leads to significant morbidity, mortality and cost of treatment.Hence, aggressive pain management is a vital component of rib fracture management for the healing of rib fractures, improvement of pulmonary functions, and pulmonary rehabilitation.

The number of rib fractures >3, rib fracture locations, bilateral rib fractures, intraparenchymal pulmonary injuries, flail chest, and a first rib fracture influence the mortality rates.

The involvement of acute pain services in Multiple rib fractures (MRFs) is based on "Rib Fracture score". Rib fracture score = (breaks × sides) + age factor. "Breaks" is the total number of fractures to the rib. Score of 1 is for unilateral fractures and 2 for bilateral fractures. Age is factored into the equation due to an increased risk of complications (age factor = 0 if <50 years; 1 if 51-60 years; 2 if 61-70 years; 3 if 71-80 years; 4 if above 80 years). A score >7, requires the involvement of acute pain team.

There is a wide variety of strategies for treating acute pain , including multimodal opioid and non-opioid systemic analgesics, regional anesthesia including thoracic epidural analgesia (TEA), paravertebral blocks (PVB),intercostal nerve blocks and a recent expansion in the use of novel fascial plane blocks.

Ultrasound-guided Serratus Anterior Plane (SAP) block is an ultrasound (US) guided interfascial plane block which has been used in managing pain due to MRFs. It is a relatively recent technique, first described in 2013, that provides almost complete analgesia for the thoracic wall by blocking the lateral branches of the intercostal nerves from T2 to L2. Two planes were described, one superficial to serratus anterior muscle and second underneath the muscle and above the rib. It is a safe, simple to perform block with no significant contraindications or side effects. It can be performed in patients lying supine, rendering it particularly useful in polytrauma patients who are unable to sit up or turn lateral for regional blocks on the back. It can be safely given to polytrauma patients who may be having hemodynamic instability or coagulopathy, unlike epidural and paravertebral. There is a theoretical possibility of local anesthetic toxicity and hematoma such as other interfacial plane blocks. Pneumothorax is a potential complication, but under ultrasound guidance, it would be a remote possibility as the injection is far from the pleura between two muscles or above the rib.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥18 years
  • Rib fracture score of more than 7
  • Patient with isolated multiple rib fractures, ●American Society of Anesthesiologists classification of physical status < IV
  • Body mass index (BMI) ≤ 35.

排除标准

  • Refusal of the patient
  • Trauma survey include multiple injuries including head injuries, visceral and long bone fractures
  • Intubated patients
  • Known hypersensitivity to any study medication, ●Chronic opioid use or chronic pain patient, ●Hemodynamic instability
  • Haemothorax or pneumothorax.

研究组 & 干预措施

US-guided SAP block group

Active Comparator

Patients will receive US-guided SAP block with a bolus of 2 mg/kg levobupivacaine made up to a volume of 40 ml followed by an infusion of 0.125% levobupivacaine will be commenced at rate of 8 ml/hr for 48 hr.

干预措施: Ultrasound-guided continuous serratus anterior plane block (Procedure)

Dexmedetomidine group

Active Comparator

Patients will receive initial loading dose of dexmedetomidine of 1 µg/kg over 30 min followed by a continuous infusion at a rate of 0.5 µg/kg/hr for 48 hr.

干预措施: intravenous dexmedetomidine infusion (Drug)

结局指标

主要结局

Quality of analgesia measured by visual analogue scale

时间窗: The first 48 hours.

rate pain severity scored from 0 to 10; while 0 stands for no pain at all and 10 is the worst intolerable pain.

次要结局

  • Sedation score(Every 8 hours for 48 hours)
  • parameters of adequate ventilation and oxygenation(at 1, 2, 3, 4, 8, 16, 24, 36, 48 hours.)

研究者

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

Dina Mahmoud Fakhry

Assistant Lecturer of Anesthesiology, Surgical Intensive Care and Pain Management

Beni-Suef University

研究点 (1)

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