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

March 23, 2019 updated by: Samaa Rashwan

Efficacy of Serratus Anterior Plane Block Versus Thoracic Paravertebral Block in Patients With Unilateral Multiple Rib Fractures: Comparative Randomized Study

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 .

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Anticipated)

24

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Banī Suwayf, Egypt
        • Recruiting
        • Beni-Suef University hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
the observation will be for 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samaa Rashwan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

May 1, 2019

Primary Completion (ANTICIPATED)

December 1, 2019

Study Completion (ANTICIPATED)

December 1, 2019

Study Registration Dates

First Submitted

March 17, 2019

First Submitted That Met QC Criteria

March 23, 2019

First Posted (ACTUAL)

March 26, 2019

Study Record Updates

Last Update Posted (ACTUAL)

March 26, 2019

Last Update Submitted That Met QC Criteria

March 23, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • Beni-Suef University Hospital

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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