Thoracic Epidural Analgesia in Multiple Traumatic Fracture Ribs

Not Applicable

• Conditions: Thoracic Epidural Analgesia, Fracture Ribs
• Interventions: Drug: Bupivacaine; Drug: Magnesium Sulfate; Drug: Fentanyl; Procedure: Thoracic epidural

• Registration Number: NCT03595397
• Lead Sponsor: Assiut University

Brief Summary

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

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.

Study Timeline

• Status Verified: 2018-07
• Study Start: 2018-07
• Study First Submitted: 2018-07-01
• Study First Submitted QC: 2018-07-12
• Last Update Submitted: 2018-07-12
• Study First Posted: 2018-07-23
• Last Update Posted: 2018-07-23
• Primary Completion: 2019-07
• Study Completion: 2019-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

Exclusion Criteria

1. Patient refusal
2. BMI more than 30 kg/m2
3. Need for mechanical ventilation on admission
4. Hemodynamic instability
5. Haemothorax or Pneumothorax
6. Contraindications of performing blocks as coagulopathy, vertebral column deformities, local infection
7. Traumatic head injury
8. Allergy to local anesthetic agents

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group III	Thoracic epidural	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
Group I	Bupivacaine	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
Group I	Thoracic epidural	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
Group II	Thoracic epidural	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
Group II	Magnesium Sulfate	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
Group III	Fentanyl	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

Primary Outcome Measures

Name	Time	Method
Difference in Pain Scores (Visual Analogue pain scale)	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)

Secondary Outcome Measures

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