Clinical trial NCT04575272: Ultrasound-guided Deep Versus Superficial Continuous Serratus Anterior Plane Block for Pain Management in Patients With Multiple Rib Fractures
Official title: Ultrasound-guided Deep Versus Superficial Continuous Serratus Anterior Plane Block for Pain Management in Patients With Multiple Rib Fractures: Randomized Double-blind Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Rib Fractures
Pain, Acute
Serratus Anterior Plane Block
Keywords: serratus anterior plane block
multiple rib fractures
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-10-05
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in pain score
timeFrame: before and after the block at "30 minutes", "2hours", "4hours", "6hours", "12hours", "24hours", "36hours", "48 hours" & "72hours"
Secondary outcomes:
measure: Change in inspiratory volumes (mL)
timeFrame: before and after block at "90 minutes" then every "12hours" for 3 days
measure: change in Serum beta-endorphin level
timeFrame: before procedure and at 24 hours post procedure
measure: Lung Ultrasound Score (LUSS)
timeFrame: before and after block at "90 minutes" then every "24 hours" for 3 days
measure: mean arterial blood pressure
timeFrame: before and after the block every "2hours" for 3 days
measure: heart rate
timeFrame: before and after the block every "2hours" for 3 days
measure: peripheral arterial oxygen saturation (SpO2)
timeFrame: before and after the block every "2hours" for 3 days
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University
Study officials:
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