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Serratus Anterior Plane Block , Paravertebral Block and Quality of Analgesia in Patients With Blunt Chest Trauma

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ClinicalTrials.gov Identifier: NCT03890757
Recruitment Status : Recruiting
First Posted : March 26, 2019
Last Update Posted : March 26, 2019
Sponsor:
Information provided by (Responsible Party):
Samaa Rashwan, Beni-Suef University

Brief Summary:
Pain associated with rib movement cause inability to cough and breathe deeply that leads to reduction in the tidal volume and predisposes to significant atelectasis, sputum retention, pneumonia and a reduction in functional residual capacity .These factors in turn lead to decreased lung compliance, ventilation perfusion mismatch, hypoxemia and respiratory distress. Therefore, effective pain relief remains the cornerstone of management to prevent serious respiratory complications .

Condition or disease Intervention/treatment
Analgesia Other: ultrasound guided paravertebral or serratus anterior block

Detailed Description:
Thoracic paravertebral block and other regional techniques like intrapleural block and intercostal nerve blocks have variable success and high potential for local anaesthetic toxicity. Serratus anterior plane block is relatively novel technique that is less invasive, easier to perform and improve pulmonary function that reduces the incidence of pneumonia, number of ventilator days, and mortality, especially those sustaining five or more rib fractures

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 24 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 2 Days
Official Title: Efficacy of Serratus Anterior Plane Block Versus Thoracic Paravertebral Block in Patients With Unilateral Multiple Rib Fractures: Comparative Randomized Study
Estimated Study Start Date : May 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
serratus anteriorblock
Serratus plane block will be performed with the patient in the lateral position and the arm abducted. Using a high-frequency linear ultrasound probe
Other: ultrasound guided paravertebral or serratus anterior block

Patients groups will be as follow:

Group (I): Serratus plane block will be performed with the patient in the lateral position and the arm abducted. Using a high-frequency linear ultrasound probe ,Group (II): thoracic paravertebral block will be performed in the sitting position. The spinal level chosen for needle insertion will be two segments below the upper most fractured rib or midway between the upper most and lowest fractured rib, 2-2.5 cm distance from the midline in the same injury site





Primary Outcome Measures :
  1. The primary outcome of this study was to compare ultrasound guided serratus anterior plane block and ultrasound guided paravertebral block as regard the efficacy of analgesia in patients with blunt chest trauma with unilateral multiple rib fractures [ Time Frame: VAS will be recorded before performing the technique , this will be the base line record, then it will be compared by the value of VAS 30 minutes after performing the technique and the value of VAS at 1, 3, 6,12 and 24 hours ]
    pain will be assessed by the visual analogue scale(VAS)


Secondary Outcome Measures :
  1. total dose of rescue analgesia [ Time Frame: the observation will be for 24 hours ]
    Analgesic requirement in the form of 25 mg pethidin intravenously if VAS score >3



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   adult malesandfemales
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients aging from 20 to 70 years old. - ASA physical status status I-II

-- Patients suffering from blunt chest trauma with unilateral multiple rib fractures.

Criteria

Inclusion Criteria:Patients aging from 20 to 70 years old.

  • ASA physical status status I-II -- Patients suffering from blunt chest trauma with unilateral multiple rib fractures.

Exclusion Criteria:• Spinal cord injury.

  • Epidural or spinal cord haematoma.
  • Thoracic vertebral body fracture.
  • Spinal injury awaiting assessment.
  • Coagulopathy (platelets <50×109 litre-1, INR>1.5).
  • Local infection or sepsis.
  • Allergy to local anaesthetic.
  • Inability to position patient due to associated injuries.
  • Severe traumatic brain injury.
  • Unstable lumbar or cervical spinal fractures.
  • Hypotension.
  • Hypovolaemia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03890757


Contacts
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Contact: Samaa A Rashwan, MD 020120159125 samakassemrashwan@gmail.com

Locations
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Egypt
Beni-Suef University Hospital Recruiting
Banī Suwayf, Egypt
Contact: Samaa Rashwan, MD    0201270159125      
Sponsors and Collaborators
Samaa Rashwan
Investigators
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Principal Investigator: Samaa Rashwan, MD Assisstant proffesor of anesthesia
Additional Information:

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Responsible Party: Samaa Rashwan, Samaa Abou Alkassem Rashwan, Beni-Suef University
ClinicalTrials.gov Identifier: NCT03890757    
Other Study ID Numbers: Beni-Suef University Hospital
First Posted: March 26, 2019    Key Record Dates
Last Update Posted: March 26, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No