Clinical trial NCT03595397: Thoracic Epidural Analgesia in Multiple Traumatic Fracture Ribs
Official title: Comparative Study of Magnesium Sulfate Versus Fentanyl as Adjuvants to Bupivacaine for Thoracic Epidural Analgesia in Multiple Traumatic Fracture Ribs
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Thoracic Epidural Analgesia, Fracture Ribs
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-07-23
Enrollment: 60
Sex: ALL
Minimum age (years): 16
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Difference in Pain Scores (Visual Analogue pain scale)
timeFrame: 48 hours
Secondary outcomes:
measure: Development of pulmonary complications: respiratory rate by breath per minute (need for mechanical ventilation)
timeFrame: 48 hours
measure: Assessment of parameters of adequate ventilation and oxygenation: PaO2/FIO2 ratio
timeFrame: 48 hours
measure: Assessment of parameters of adequate ventilation and oxygenation: PaCO2 in mmHg
timeFrame: 48 hours
measure: Changes in heart rate (HR) by beats per minute
timeFrame: 48 hours
measure: changes in arterial blood pressure (ABP) by mmHg
timeFrame: 48 hours
Other outcomes:
Locations:
Study officials:
References:
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citation: Dehghan N, de Mestral C, McKee MD, Schemitsch EH, Nathens A. Flail chest injuries: a review of outcomes and treatment practices from the National Trauma Data Bank. J Trauma Acute Care Surg. 2014 Feb;76(2):462-8. doi: 10.1097/TA.0000000000000086.
citation: Flagel BT, Luchette FA, Reed RL, Esposito TJ, Davis KA, Santaniello JM, Gamelli RL. Half-a-dozen ribs: the breakpoint for mortality. Surgery. 2005 Oct;138(4):717-23; discussion 723-5. doi: 10.1016/j.surg.2005.07.022.
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citation: Wu CL, Jani ND, Perkins FM, Barquist E. Thoracic epidural analgesia versus intravenous patient-controlled analgesia for the treatment of rib fracture pain after motor vehicle crash. J Trauma. 1999 Sep;47(3):564-7. doi: 10.1097/00005373-199909000-00025.
citation: Mackersie RC, Karagianes TG, Hoyt DB, Davis JW. Prospective evaluation of epidural and intravenous administration of fentanyl for pain control and restoration of ventilatory function following multiple rib fractures. J Trauma. 1991 Apr;31(4):443-9; discussion 449-51.