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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03890757
Other study ID # Beni-Suef University Hospital
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 2019
Est. completion date December 2019

Study information

Verified date March 2019
Source Beni-Suef University
Contact Samaa A Rashwan, MD
Phone 020120159125
Email samakassemrashwan@gmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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 .


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


Recruitment information / eligibility

Status Recruiting
Enrollment 24
Est. completion date December 2019
Est. primary completion date December 2019
Accepts healthy volunteers No
Gender All
Age group 20 Years to 70 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Egypt Beni-Suef University Hospital Bani Suwayf

Sponsors (1)

Lead Sponsor Collaborator
Samaa Rashwan

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 pain will be assessed by the visual analogue scale(VAS) 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
Secondary total dose of rescue analgesia Analgesic requirement in the form of 25 mg pethidin intravenously if VAS score >3 the observation will be for 24 hours
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