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Thoracic Epidural Analgesia in Multiple Traumatic Fracture Ribs

A

Assiut University

Status

Unknown

Conditions

Thoracic Epidural Analgesia, Fracture Ribs

Treatments

Procedure: Thoracic epidural
Drug: Fentanyl
Drug: Magnesium Sulfate
Drug: Bupivacaine

Study type

Interventional

Funder types

Other

Identifiers

NCT03595397
Thoracic Epidural analgesia

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

16 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

60 participants in 3 patient groups

Group I
Active Comparator group
Description:
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
Treatment:
Drug: Bupivacaine
Procedure: Thoracic epidural
Group II
Active Comparator group
Description:
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
Treatment:
Drug: Magnesium Sulfate
Procedure: Thoracic epidural
Group III
Active Comparator group
Description:
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
Treatment:
Drug: Fentanyl
Procedure: Thoracic epidural

Trial contacts and locations

0

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Central trial contact

Emad Z Kamel, Lecturer; Ahmed K Fathy, resident

Data sourced from clinicaltrials.gov

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