Thoracic Epidural Analgesia in Multiple Traumatic Fracture Ribs

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

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.

Study Overview

• Status: Unknown
• Conditions: Thoracic Epidural Analgesia, Fracture Ribs
• Intervention / Treatment: Drug: Bupivacaine; Procedure: Thoracic epidural; Drug: Magnesium Sulfate; Drug: Fentanyl

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group I; 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; 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; Procedure: Thoracic epidural; All patients will receive mid-thoracic epidural analgesia
Active Comparator: Group II; 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	Procedure: Thoracic epidural; All patients will receive mid-thoracic epidural analgesia; Drug: 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 mixture of 0.125% bupivacaine and 20% Magnesium sulfate; Other Names: bupivacaine
Active Comparator: Group III; 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	Procedure: Thoracic epidural; All patients will receive mid-thoracic epidural analgesia; Drug: 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.; Other Names: bupivacaine

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

• Gage A, Rivara F, Wang J, Jurkovich GJ, Arbabi S. The effect of epidural placement in patients after blunt thoracic trauma. J Trauma Acute Care Surg. 2014 Jan;76(1):39-45; discussion 45-6. doi: 10.1097/TA.0b013e3182ab1b08.
• 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.
• Ziegler DW, Agarwal NN. The morbidity and mortality of rib fractures. J Trauma. 1994 Dec;37(6):975-9. doi: 10.1097/00005373-199412000-00018.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2018
• Primary Completion (Anticipated): July 1, 2019
• Study Completion (Anticipated): August 1, 2019

Study Registration Dates

• First Submitted: July 1, 2018
• First Submitted That Met QC Criteria: July 12, 2018
• First Posted (Actual): July 23, 2018

Study Record Updates

• Last Update Posted (Actual): July 23, 2018
• Last Update Submitted That Met QC Criteria: July 12, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Thoracic Injuries; Fractures, Bone; Rib Fractures; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Membrane Transport Modulators; Adjuvants, Anesthesia; Anticonvulsants; Anesthetics, Local; Calcium-Regulating Hormones and Agents; Reproductive Control Agents; Calcium Channel Blockers; Tocolytic Agents; Fentanyl; Bupivacaine; Magnesium Sulfate
• Other Study ID Numbers: Thoracic Epidural analgesia

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No