Mid-point to Pleura Transverse Process Block Versus Thoracic Intervertebral Foramen Block

Study Overview
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Brief Summary
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The analgesic effect of continuous mid-point to pleura transverse process block compared to the analgesic effect of continuous thoracic intervertebral foramen block, in patients with multiple rib fractures.

Detailed Description
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The analgesic effect of continuous mid-point to pleura transverse process block will be compared to the analgesic effect of continuous thoracic intervertebral foramen block, in patients with multiple rib fractures, by using the numeric rating scale (NRS) for pain.

Official Title
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Mid-point to Pleura Transverse Process Continuous Block Versus Thoracic Intervertebral Foramen Continuous Block, for Analgesia in Polytraumatic Patients With Multiple Rib Fractures

Conditions
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Pain, Acute, Rib Fractures, Polytrauma

Intervention / Treatment
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* Procedure: Thoracic intervertebral foramen block
* Procedure: Mid-point to pleura transverse process block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ribs fracture after polytrauma Exclusion Criteria: pregnancy allergy to anesthetics head trauma history of neurological impairment (primary or secondary) history of cancer history of chronic obstructive pulmonary disease infections of skin close to the block site systemic infections

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Thoracic intervertebral foramen block<br>Under ultrasound guidance the continuous thoracic intervertebral foramen block, will be provided to achieve analgesia in polytraumatic patients with rib fractures. A set for continuous peripheral nerve block will be used. The infusion rate of analgesic solution (levobupivacaine 0.25% combined with dexamethasone 16 mg) will be titrated to patient perceived pain. | Procedure: Thoracic intervertebral foramen block<br>* Under ultrasound guidance the continuous thoracic intervertebral foramen block, will be provided to achieve analgesia in polytraumatic patients with rib fractures. A set for continuous peripheral nerve block will be used. The infusion rate of analgesic solution (levobupivacaine 0.25% combined with dexamethasone 16 mg) will be titrated to patient perceived pain. The block will be performed close, by considering the level of rib fractures.<br>|
| Active Comparator: Mid-point to pleura transverse process block<br>Under ultrasound guidance the continuous mid-point to pleura transverse process block, will be provided to achieve analgesia in polytraumatic patients with rib fractures. A set for continuous peripheral nerve block will be used. The infusion rate of analgesic solution (levobupivacaine 0.25% combined with dexamethasone 16 mg) will be titrated to patient perceived pain. | Procedure: Mid-point to pleura transverse process block<br>* Under ultrasound guidance the continuous mid-point to pleura transverse process block, will be provided to achieve analgesia in polytraumatic patients with rib fractures. A set for continuous peripheral nerve block will be used. The infusion rate of analgesic solution (levobupivacaine 0.25% combined with dexamethasone 16 mg) will be titrated to patient perceived pain. The block will be performed close, by considering the level of rib fractures.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity | The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. no pain) to '10' representing the other pain extreme (e.g. pain as bad as you can imagine or worst pain imaginable | First 72 hours from the block | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diaphragmatic motion | The percentage of diaphragmatic thickening measured as thickness at end-inspiration-thickness at end-expiration divided by thickness at end-expiration | First 72 hours from the block | 
| Arterial blood gas analysis | Fraction of inspired oxygen to partial pressure of oxygen ratio | First 72 hours from the block | 
| Airflow rate | Patient airflow rate measured in mL/second, by using an incentive spirometer with three balls | First 72 hours from the block | 
| Blood pressure | Invasive blood pressure (systolic and diastolic pressure in mmHg) | First 72 hours from the block | 
| Sensory block | Response to the stimulus (yes or no), by using a piece of cotton, and ice in a finger of surgical glove on the patient's skin. | First 72 hours from the block | 
| Request of analgesic drugs | Consumption of analgesic drugs (equivalent mg of morphine) | First 72 hours from the block | 
| Anesthetic spread | Thoracic paravertebral space spread (yes or no), evaluated with ultrasonography | First 72 hours from the block | 
| Complication | Number of pneumothorax, hemothorax, hematoma, pain, infection, and neurological impairment by the block | First 72 hours from the block | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Analgesia, Local anesthetics, Myofascial block, Ultrasound guidance