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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04575272
Enrollment
62
Registered
2020-10-05
Start date
2021-08-03
Completion date
2023-12-10
Last updated
2024-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

serratus anterior plane block, multiple rib fractures

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.

Interventions

Local anesthetic infusion though a peripheral nerve catheter placed related to the serratus anterior muscle at the level of the 5th rib

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

neither the patient or the investigator included in data collection will be aware of the type of block performed or the group allocation

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in pain scorebefore and after the block at 30 minutes, 2hours, 4hours, 6hours, 12hours, 24hours, 36hours, 48 hours & 72hourspatient report numerical rating scale (NRS) 0 to 10, with 0 being no pain and 10 being the worst pain imaginable

Secondary

MeasureTime frameDescription
change in Serum beta-endorphin levelbefore procedure and at 24 hours post procedureWe will use radioimmunoassays to measure plasma beta-endorphin level
Lung Ultrasound Score (LUSS)before and after block at 90 minutes then every 24 hours for 3 daysWe 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).
Change in inspiratory volumes (mL)before and after block at 90 minutes then every 12hours for 3 daysMaximum inspiratory respiratory volume (measured in ml) recorded on single use of incentive spirometer device
heart ratebefore and after the block every 2hours for 3 daysheart rate by EKG monitor
peripheral arterial oxygen saturation (SpO2)before and after the block every 2hours for 3 daysmeasured by Pulse oximetry
mean arterial blood pressurebefore and after the block every 2hours for 3 daysmean arterial blood pressure by non invaisive blood pressure monitoring

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026