AnalgesiaNCT03890757
Serratus Anterior Plane Block , Paravertebral Block and Quality of Analgesia in Patients With Blunt Chest Trauma
An observational study of Analgesia, run by Samaa Rashwan at 1 site in Egypt.
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… Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Analgesia
- What is being tested?
- ultrasound guided paravertebral or serratus anterior block
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- May 2019to Dec 2019
- How long will I take part?
- 2 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- ASA physical status status I-II -- Patients suffering from blunt chest trauma with unilateral multiple rib fractures.
Who cannot join
- 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.
Show all 11Show fewer
- Inability to position patient due to associated injuries.
- Severe traumatic brain injury.
- Unstable lumbar or cervical spinal fractures.
- Hypotension.
- Hypovolaemia
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Beni-Suef University Hospital
Banī Suwayf
Samaa Rashwan, MD, 0201270159125
About this study
Official title: 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 .
Read the 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
- Conditions
- Analgesia
- Being tested
- ultrasound guided paravertebral or serratus anterior block
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound guided paravertebral or serratus anterior blockOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: ultrasound guided paravertebral or serratus anterior block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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 outcomes (1)
total dose of rescue analgesia
Analgesic requirement in the form of 25 mg pethidin intravenously if VAS score >3
Measured: the observation will be for 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2019
- Study startMay 2019 (estimated)
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 24 participants (estimated)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Samaa Rashwan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Samaa Rashwan, Beni-Suef University
- Investigators
- Samaa Rashwan, MD, Principal investigator, Assisstant proffesor of anesthesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03890757
- Sponsor's protocol ID
- Beni-Suef University Hospital
- Status last verified
- Mar 2019
- First submitted
- 17 Mar 2019
- Last updated
- 26 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Serratus Anterior Plane Block Versus Thoracic Paravertebral Block in Patients With Unilateral Multiple Rib Fractures: Comparative Randomized Study
- ClinicalTrials.gov ID
- NCT03890757
- Acronym / sponsor ID
- Beni-Suef University Hospital
- Conditions
- Analgesia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Samaa RashwanUniversity, hospital or other
- Study start
- May 2019 (estimated)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 26 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 2 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| serratus anteriorblock | – | Other: ultrasound guided paravertebral or serratus anterior blockSerratus plane block will be performed with the patient in the lateral position and the arm abducted. Using a high-frequency linear ultrasound probe |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- ASA physical status status I-II -- Patients suffering from blunt chest trauma with unilateral multiple rib fractures.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasound guided paravertebral or serratus anterior blockPatients 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 | Other | serratus anteriorblock |
Primary outcome
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)
1 secondary outcome
total dose of rescue analgesia
Time frame: the observation will be for 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samaa Rashwan, MD principal investigator
Assisstant proffesor of anesthesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Analgesia, run by Samaa Rashwan at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Samaa A Rashwan, MD (020120159125, samakassemrashwan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2019.