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临床试验/NCT03595397
NCT03595397Unknown不适用

Comparative Study of Magnesium Sulfate Versus Fentanyl as Adjuvants to Bupivacaine for Thoracic Epidural Analgesia in Multiple Traumatic Fracture Ribs

Assiut University0 个研究点目标入组 60 人开始时间: 2018年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
60
主要终点
Difference in Pain Scores (Visual Analogue pain scale)

研究概览

简要总结

This work aims at comparing the analgesic effect of Thoracic Epidural Magnesium sulfate versus Fentanyl when added as adjuvants to Bupivacaine in patients with multiple traumatic fracture ribs.

详细描述

Rib fractures are a common condition following trauma with a reported incidence of up to 10% in trauma in general, and up to 39% in blunt chest trauma. Traumatic rib fractures are associated with significant morbidity and mortality, and mortality rates reaching 10-16% has been reported. An estimated one third of patients with traumatic rib fractures develop secondary pulmonary complications with an associated mortality rate as high as 65% . Pain is recognized as a contributing factor to adverse outcome in traumatic rib fractures due to pain-induced inadequate respiratory efforts leading to atelectasis, difficulties in clearing secretions and an increased risk of developing pneumonia. Consequently, adequate analgesia is considered a core intervention in the management of patients with traumatic rib fractures.

There are a variety of ways to manage a patient's pain. Oral analgesic drugs and regional modes are more likely to be used .

Regional analgesia is often supplemented with a small dose of either NSAIDs or opioids and pain reduction is typically strong and immediate. There is little sedation, so evaluation of head and abdominal injuries is easier. A major disadvantage is the technical complexity of the procedures, leading to occasional errors in the administering of the treatments. They can also be painful while the needle is entering (or catheter is being installed), toxicity is a possibility, and the patients require more intensive monitoring and care by the physicians and nurses. There are a variety of modes; the four most common are TEA, thoracic paravertebral block, intercostal block, and intrapleural block. This study focuses on thoracic epidural analgesia.

Narcotic infusions and continuous local anesthetic can be delivered through thoracic or lumbar epidural catheters. Opioid receptors exist in the spinal cord that can alter the perception of pain without needing stimulation of receptors in the brain. After inserting the catheter into this area, local anesthetics and narcotics are administered, blocking the anterior and posterior nerve roots crossing this space. The anesthetic/analgesic agents diffuse across the dura and begin to block sensory nerves. Motor nerves are affected to a lesser degree. It takes a large dose to achieve the desired effect.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
16 Years 至 75 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients 16 years of age and greater
  • Non-intubated at the time of block placement
  • Traumatic Rib Fractures two or greater
  • Block must be done within 12-24 hours of presentation to the emergency room
  • ASA physical status: I-II

排除标准

  • Patient refusal
  • BMI more than 30 kg/m2
  • Need for mechanical ventilation on admission
  • Hemodynamic instability
  • Haemothorax or Pneumothorax
  • Contraindications of performing blocks as coagulopathy, vertebral column deformities, local infection
  • Traumatic head injury
  • Allergy to local anesthetic agents

研究组 & 干预措施

Group I

Active Comparator

20 patients will receive mid-thoracic epidural analgesia with a loading dose of 8 ml of 0.125% bupivacaine, followed by continuous infusion of 8 ml/hour

干预措施: Bupivacaine (Drug)

Group I

Active Comparator

20 patients will receive mid-thoracic epidural analgesia with a loading dose of 8 ml of 0.125% bupivacaine, followed by continuous infusion of 8 ml/hour

干预措施: Thoracic epidural (Procedure)

Group II

Active Comparator

20 patients will receive mid-thoracic epidural analgesia with a loading dose of 8 ml mixture of 0.125% bupivacaine and 30 mg/kg magnesium sulfate, followed by continuous infusion of 8 ml/hour of a mixture of 0.125% bupivacaine and 20% magnesium sulfate

干预措施: Magnesium Sulfate (Drug)

Group II

Active Comparator

20 patients will receive mid-thoracic epidural analgesia with a loading dose of 8 ml mixture of 0.125% bupivacaine and 30 mg/kg magnesium sulfate, followed by continuous infusion of 8 ml/hour of a mixture of 0.125% bupivacaine and 20% magnesium sulfate

干预措施: Thoracic epidural (Procedure)

Group III

Active Comparator

20 patients will receive mid-thoracic epidural analgesia with a loading dose of 8 ml of 0.125 bupivacaine and 2 mcg/ml fentanyl, followed by continuous infusion of 8 ml/hour

干预措施: Fentanyl (Drug)

Group III

Active Comparator

20 patients will receive mid-thoracic epidural analgesia with a loading dose of 8 ml of 0.125 bupivacaine and 2 mcg/ml fentanyl, followed by continuous infusion of 8 ml/hour

干预措施: Thoracic epidural (Procedure)

结局指标

主要结局

Difference in Pain Scores (Visual Analogue pain scale)

时间窗: 48 hours

Visual analog scale \[VAS\] is a measure of pain intensity. It is a continuous scale comprised of a horizontal or vertical scale usually 10 cm or 100 mm length. For pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 \[on 100-mm scale\]. The pain visual analog scale is self completed by the respondent. The respondent is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. After the patient has marked, using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark. The scores can be from 0-100. A higher score indicates greater pain intensity. Based on the distribution of pain, the following cut points on the pain VAS have been recommended: No pain (0 -4 mm) Mild pain (5-44 mm) Moderate pain (45-74 mm) Severe pain (75-100 mm)

次要结局

  • Assessment of parameters of adequate ventilation and oxygenation: PaO2/FIO2 ratio(48 hours)
  • Assessment of parameters of adequate ventilation and oxygenation: PaCO2 in mmHg(48 hours)
  • Development of pulmonary complications: respiratory rate by breath per minute (need for mechanical ventilation)(48 hours)
  • Changes in heart rate (HR) by beats per minute(48 hours)
  • changes in arterial blood pressure (ABP) by mmHg(48 hours)

研究者

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

Ahmed khalid Fathy

Principal investigator

Assiut University

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