Thoracic Epidural Analgesia in Multiple Traumatic Fracture Ribs

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Thoracic Epidural Analgesia, Fracture Ribs

Intervention / Treatment
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* Drug: Bupivacaine
* Drug: Magnesium Sulfate
* Drug: Fentanyl
* Procedure: Thoracic epidural


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group I<br>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 | Drug: Bupivacaine<br>* 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<br>Procedure: Thoracic epidural<br>* All patients will receive mid-thoracic epidural analgesia<br>|
| Active Comparator: Group II<br>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 | Drug: Magnesium Sulfate<br>* 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 mixture of 0.125% bupivacaine and 20% Magnesium sulfate<br>* Other names: bupivacaine;Procedure: Thoracic epidural<br>* All patients will receive mid-thoracic epidural analgesia<br>|
| Active Comparator: Group III<br>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 | Drug: Fentanyl<br>* 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.<br>* Other names: bupivacaine;Procedure: Thoracic epidural<br>* All patients will receive mid-thoracic epidural analgesia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in Pain Scores (Visual Analogue pain scale) | 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) | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of pulmonary complications: respiratory rate by breath per minute (need for mechanical ventilation) | By observing respiratory rate of patients using clinical assessment every 1 hour | 48 hours | 
| Assessment of parameters of adequate ventilation and oxygenation: PaO2/FIO2 ratio | by measuring O2 level in the blood using arterial blood gases every 3 hours | 48 hours | 
| Assessment of parameters of adequate ventilation and oxygenation: PaCO2 in mmHg | by measuring CO2 level in the blood using arterial blood gases every 3 hours | 48 hours | 
| Changes in heart rate (HR) by beats per minute | By monitoring patients heart rate every 1 hour | 48 hours | 
| changes in arterial blood pressure (ABP) by mmHg | By monitoring patients arterial blood pressure using non invasive arterial blood pressure monitoring every 1 hour | 48 hours |