Erector Spinae Plane Block Versus Thoracic Epidural Analgesia in Patients With Multiple Fracture Ribs

Study Overview
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Brief Summary
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To assess the analgesic and respiratory effect of continuous Erector Spinae Plane block versus Thoracic Epidural in patients with multiple fracture ribs.

Detailed Description
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Erector spinae plane (ESP) block is a recently described technique which may be an alternative to Paravertebral block (PVB) for providing thoracic analgesia. It involves injection of local anesthetic into the fascial plane deep to erector spinae muscle. ESP is a more superficial block with a better defined end-point injection between the bony transverse process and erector spinae muscle. A more superficial ultrasound-guided block will be faster to perform and less painful for the patient. ESP does not have the same risk of pneumothorax as PVB. Epidural analgesia has become the standard of care. Although thoracic epidurals provide excellent analgesia for the management of rib fractures, they are limited to a certain population due to patient factors and side-effects. Many trauma patients have other injuries which contraindicate the use of epidurals, or which prevent positioning for insertion. There are disadvantages to thoracic epidural analgesia. They are technically challenging to insert, with a risk of dural puncture or spinal cord injury. Adverse effects include hypotension, and if opioids used, urinary retention and pruritus. Patients can develop a motor block and are unable to mobilize with an epidural in situ.

Official Title
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Erector Spinae Plane Block Versus Thoracic Epidural Analgesia in Patients With Multiple Fracture Ribs

Conditions
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Fracture; Rib, Multiple

Intervention / Treatment
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* Device: Ultrasound
* Drug: Bupivacaine HCl Inj 0.25%
* Drug: Bupivacaine Hydrochloride, 0.125%-0.9% Injectable Solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with multiple fracture ribs. Exclusion Criteria: Patient refusal. Patients with pre-existing infection at the block site. Coagulopathy. Allergy to local anesthetics. Pre-existing neurological deficits. Psychiatric illness.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Thoracic Epidural Analgesia group<br>25 patients will receive ultrasound-guided thoracic epidural analgesia for multiple fracture ribs at the level of T8 with 7.5-12 ml of Bupivacaine HCl Inj 0.25% as a loading dose followed by catheter insertion and infusion of Bupivacaine Hydrochloride, 0.125%-0.9% Injectable Solution at 5-7 ml/h. For breakthrough pain bolus of Bupivacaine Hydrochloride, 0.125%-0.9% Injectable Solution 5-10 ml can be used. | Device: Ultrasound<br>* Ultrasound-guided Thoracic Epidural Analgesia and Erector spinae plane block.<br>Drug: Bupivacaine HCl Inj 0.25%<br>* Bupivacaine HCl Inj 0.25% will be used in both blocks by the same dose of 7.5-12 ml<br>Drug: Bupivacaine Hydrochloride, 0.125%-0.9% Injectable Solution<br>* infusion of Bupivacaine Hydrochloride, 0.125%-0.9% Injectable Solution at 5-7 ml/h will be used in both blocks and also for breakthrough pain after both blocks as a bolus of 5-10 ml.<br>|
| Active Comparator: Erector spinae plane block group<br>25 patients will receive ultrasound-guided ESP block for multiple fracture ribs at the level from T1 to T5 with 7.5-12 ml of Bupivacaine HCl Inj 0.25% as a loading dose followed by catheter insertion and infusion of Bupivacaine Hydrochloride, 0.125%-0.9% Injectable Solution at 5-7 ml/h. For breakthrough pain bolus of Bupivacaine Hydrochloride, 0.125%-0.9% Injectable Solution 5-10 ml can be used. | Device: Ultrasound<br>* Ultrasound-guided Thoracic Epidural Analgesia and Erector spinae plane block.<br>Drug: Bupivacaine HCl Inj 0.25%<br>* Bupivacaine HCl Inj 0.25% will be used in both blocks by the same dose of 7.5-12 ml<br>Drug: Bupivacaine Hydrochloride, 0.125%-0.9% Injectable Solution<br>* infusion of Bupivacaine Hydrochloride, 0.125%-0.9% Injectable Solution at 5-7 ml/h will be used in both blocks and also for breakthrough pain after both blocks as a bolus of 5-10 ml.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score (verbal numeric rating scale) as the median VNRS at rest and cough | All patients will be assessed for pain score using the 11 points verbal numeric rating scale (VNRS), where zero equals no pain and 10 equals the worst pain imaginable. This assessment will be done before the block and after the block by 60 minutes and then every 6 hours up to 24 hours. | up to 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary function test | Pulmonary function test will be done before the block, 60 minutes after the block and then every 6 hours up to 24 hours. | up to 24 hours |