Ultrasound-guided Deep Versus Superficial Continuous Serratus Anterior Plane Block for Pain Management in Patients With Multiple Rib Fractures

Study Overview
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Brief Summary
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The present clinical study will be undertaken to evaluate the effect of Ultrasound-guided Deep versus Superficial continuous Serratus Anterior Plane Block for pain management in patients with multiple rib fractures.

Detailed Description
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Thoracic blunt trauma, especially when multiple rib fractures are associated, is challenging to manage and causes significant morbidity due to the severe pain implied. Patients can present with respiratory compromise as their capacity to expand the thorax is limited by pain. As a result, they are at high risk to develop atelectasis and pneumonia. the key goal of management is adequate analgesia and pulmonary volume expansion Various strategies to treat such pain have been utilized, including regional analgesia (intrapleural, intercostal paravertebral nerve blockade), and neuraxial analgesia (thoracic epidural analgesia (TEA), intrathecal opioids). The use of neuraxial analgesia in polytrauma is frequently limited by the need for aggressive venous thromboembolic (VTE) prophylaxis, and positioning of the patient for a neuraxial approach may be impossible. There is a growing interest in exploring treatments that are less invasive than EA and can be performed on patients who have contraindications to neuraxial analgesia. Ultrasound-guided Serratus Anterior Plane (SAP) block is a recent technique, first described by Blanco et al. in 2013, that provides analgesia for the thoracic wall by blocking the lateral branches of the intercostal nerves from T2 to L2. It is a safe, simple to perform block with no significant contraindications or side effects. he described 2 potential spaces, one superficial and another deep to serratus. The SAPB has been used effectively for the management of pain in the context of rib fractures, thoracoscopic surgery, thoracotomy, breast surgery, and post-mastectomy pain syndrome, few studies compared the two approaches, and the difference between them has not yet been studied in patients with multiple rib fractures.

Official Title
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Ultrasound-guided Deep Versus Superficial Continuous Serratus Anterior Plane Block for Pain Management in Patients With Multiple Rib Fractures: Randomized Double-blind Clinical Trial

Conditions
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Multiple Rib Fractures, Pain, Acute, Serratus Anterior Plane Block

Intervention / Treatment
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* Procedure: Ultrasound-guided continuous serratus anterior plane block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients of either sex, having three or more unilateral fracture ribs and admitted to the trauma ICU, Rib fractures were confirmed by X-ray and CT scan reads. Exclusion Criteria: significant head injury and unconsciousness (GCS less than 14) Patients with significant pain from other injuries pathological obesity (body mass index ≥35) history of drug allergy local anesthetics local infection at the injection site inability to obtain consent from patient or surrogate, and patient refusal

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Continuous Deep Serratus Anterior Plane Block group<br>at the level of the fifth rib in the mid-axillary line. After anaesthetizing the skin with 2 mL of lidocaine 2%, an 18-gauge Touhy needle was introduced in-plane, under direct visualization, to the plane immediately deep to the serratus anterior muscle. After negative aspiration, 35 mL of bupivacaine 0.25% will be injected. Afterwards, a 20-gauge peripheral nerve catheter will be threaded into the space. then bupivacaine 0.125% infusion at a rate of 5 ml/h by an Infusion Syringe Pump will be started. | Procedure: Ultrasound-guided continuous serratus anterior plane block<br>* Local anesthetic infusion though a peripheral nerve catheter placed related to the serratus anterior muscle at the level of the 5th rib<br>|
| Active Comparator: Continuous Superficial Serratus Anterior Plane Block group<br>at the level of the fifth rib in the mid-axillary line. After anaesthetizing the skin with 2 mL of lidocaine 2%, an 18-gauge Touhy needle was introduced in-plane, under direct visualization, to the plane immediately superficial to the serratus anterior muscle. After negative aspiration, 35 mL of bupivacaine 0.25% will be injected. Afterwards, a 20-gauge peripheral nerve catheter will be threaded into the space. then bupivacaine 0.125% infusion at a rate of 5 ml/h by an Infusion Syringe Pump will be started. | Procedure: Ultrasound-guided continuous serratus anterior plane block<br>* Local anesthetic infusion though a peripheral nerve catheter placed related to the serratus anterior muscle at the level of the 5th rib<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain score | patient report numerical rating scale (NRS) 0 to 10, with 0 being no pain and 10 being the worst pain imaginable | before and after the block at 30 minutes, 2hours, 4hours, 6hours, 12hours, 24hours, 36hours, 48 hours & 72hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in inspiratory volumes (mL) | Maximum inspiratory respiratory volume (measured in ml) recorded on single use of incentive spirometer device | before and after block at 90 minutes then every 12hours for 3 days | 
| The time of the first rescue analgesic and the total analgesic consuption | when NRS is over 4, 30 mg of i.v ketorlac will be given and its time will be recorded the total dose through 24 hr will be recorded for 3 days | day 0, day 1, day 2, day 3 | 
| change in Serum beta-endorphin level | We will use radioimmunoassays to measure plasma beta-endorphin level | before procedure and at 24 hours post procedure | 
| Lung Ultrasound Score (LUSS) | We will use a techniques based on the international evidence-based recommendations for point-of-care lung ultrasound that recommended using a complete eight-zone lung ultrasound ,The worst ultrasound pattern observed in each zone was recorded and used to calculate the sum of the scores (total score = 24). | before and after block at 90 minutes then every 24 hours for 3 days | 
| hospital stay | time to fill the discharge criteria | day for discharge, assessed up to 14 days | 
| mean arterial blood pressure | mean arterial blood pressure by non invaisive blood pressure monitoring | before and after the block every 2hours for 3 days | 
| heart rate | heart rate by EKG monitor | before and after the block every 2hours for 3 days | 
| peripheral arterial oxygen saturation (SpO2) | measured by Pulse oximetry | before and after the block every 2hours for 3 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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serratus anterior plane block, multiple rib fractures