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Completed

NCT Number: NCT04575272

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assiut University

Asyut, 71515, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasound-guided continuous serratus anterior plane block

Procedure

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

Primary outcomes

  1. Change in pain score

    Time frame: before and after the block at "30 minutes", "2hours", "4hours", "6hours", "12hours", "24hours", "36hours", "48 hours" & "72hours"

    patient report numerical rating scale (NRS) 0 to 10, with 0 being "no pain" and 10 being "the worst pain imaginable"

Secondary outcomes

  1. Change in inspiratory volumes (mL)

    Time frame: before and after block at "90 minutes" then every "12hours" for 3 days

    Maximum inspiratory respiratory volume (measured in ml) recorded on single use of incentive spirometer device

  2. change in Serum beta-endorphin level

    Time frame: before procedure and at 24 hours post procedure

    We will use radioimmunoassays to measure plasma beta-endorphin level

  3. Lung Ultrasound Score (LUSS)

    Time frame: before and after block at "90 minutes" then every "24 hours" for 3 days

    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).

  4. mean arterial blood pressure

    Time frame: before and after the block every "2hours" for 3 days

    mean arterial blood pressure by non invaisive blood pressure monitoring

  5. heart rate

    Time frame: before and after the block every "2hours" for 3 days

    heart rate by EKG monitor

  6. peripheral arterial oxygen saturation (SpO2)

    Time frame: before and after the block every "2hours" for 3 days

    measured by Pulse oximetry

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Oct 5, 2020
Registry last updated
Apr 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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