Rib FracturesNCT04554186
Serratus Anterior Plane Block Versus Thoracic Paravertebral Block.
A study testing Serratus anterior plane block and Thoracic Paravertebral block in people with Rib Fractures and Analgesia, run by Minia University at 1 site in Egypt.
Trial summary
Compare between serratus anterior plane block and thoracic Paravertebral block in analgesia for patients with multiple rib fractures Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Rib Fractures, Analgesia
- What is being tested?
- Serratus anterior plane block and Thoracic Paravertebral block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Sep 2020to 15 Jan 2021
- Phase
- Interventional
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ASA 1_3 Age 18_60 Unilateral fracture ribs
Who cannot join
- Drug allergy Morbid obese Opioid dependence Patients refuse
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Minia university hospital
Minya, 61511
Ahmed G Shehata, Master, 1067622270 ext. 0020, ahmedgamalicu@gmail.com
Omyma M Shehata, MD, 1061762894 ext. 0020, omyma.shehata44@yahoo.com
About this study
Official title: Ultrasound Guided Serratus Anterior Plane Block Versus Thoracic Paravertebral Block in Emergency Department Rib Fracture
Compare between serratus anterior plane block and thoracic Paravertebral block in analgesia for patients with multiple rib fractures
Read the detailed description
The study will be conducted in a prospective randomised controlled. Patients will be allocated into three groups
Control group:
The patient will receive fentanyl patch 50 microgram
TPVB group:
The patient will receive thoracic vertebral plane lock 0.4ml/kg bupivacaine 0.1 25% will be administered. For continuous infusion catheter will be inserted . Then a rate of 7ml / hour to max 10 ml / hour of bupivacaine 0.0625%
SAPB group,:
Patient will receive serratus anterior plane block 0.4ml / kg bupivacaine 0.125% will be injected to open the space then a catheter will be advanced For continuous infusion of 0.0625 % bupivacaine at 7 ml / hour
- Conditions
- Rib Fractures, Analgesia
- Being tested
- Serratus anterior plane block, Thoracic Paravertebral block, Control
- Keywords
- Fracture rib, TPVB, SAPB
- Medical subject headings
- Rib Fractures, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serratus anterior plane blockProcedure or surgery
Injection of bupivacaine between serratus anterior plane and latissimus dorsi muscle using ultrasound
Thoracic Paravertebral blockProcedure or surgery
Injection of bupivacaine in the thoracic Paravertebral space using ultrasound
ControlProcedure or surgery
Place a fentanyl patch 50 microgram
| Study group | Role | What they receive |
|---|---|---|
| Serratus anterior plane block | Experimental | 20 patients will receive SAP block with 0.4 ml / kg bupivacaine 0.125% then continuous infusion through a catheter at rate of 7 ml / hour to max 10 ml / hour of bupivacaine 0.0625% Receives: Procedure: Serratus anterior plane block |
| Thoracic Paravertebral block | Active comparator | 20 patients will receive TPVB 0.4ml / kg bupivacaine 0.125% then continuous infusion through a catheter at rate of 7 ml / hour to max 10 ml / hour of bupivacaine 0.0625% Receives: Procedure: Thoracic Paravertebral block |
| Control group | Placebo comparator | 20 patients will receive Fentanyl patch 50 microgram Receives: Procedure: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS score
Visual analogue pain score describe by the patient
Measured: 24 hour
Secondary outcomes (1)
Total analgesic consumption
Total opioid consume by the patient in 24 hour
Measured: 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2020
- Study start22 Sep 2020
- Primary completion1 Jan 2021 (estimated)
- Study completion15 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rib FracturesStudies of the same condition, open and under way.
- More trials run by Minia UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Gamal Shehata, Minia University
- Investigators
- Amany K Aboelhassan, Study chair, Minia University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04554186
- Sponsor's protocol ID
- 112-11/2018
- Status last verified
- Sep 2020
- First submitted
- 12 Sep 2020
- Last updated
- 23 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Serratus Anterior Plane Block Versus Thoracic Paravertebral Block in Emergency Department Rib Fracture
- ClinicalTrials.gov ID
- NCT04554186
- Acronym / sponsor ID
- 112-11/2018
- Conditions
- Rib Fractures, Analgesia
- Keywords
- Fracture rib, TPVB, SAPB
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 22 Sep 2020 (actual)
- Primary completion
- 1 Jan 2021 (estimated)
- Study completion
- 15 Jan 2021 (estimated)
- First posted
- 18 Sep 2020 (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.
Compare between serratus anterior plane block and thoracic Paravertebral block in analgesia for patients with multiple rib fractures
Detailed description
The study will be conducted in a prospective randomised controlled. Patients will be allocated into three groups
Control group:
The patient will receive fentanyl patch 50 microgram
TPVB group:
The patient will receive thoracic vertebral plane lock 0.4ml/kg bupivacaine 0.1 25% will be administered. For continuous infusion catheter will be inserted . Then a rate of 7ml / hour to max 10 ml / hour of bupivacaine 0.0625%
SAPB group,:
Patient will receive serratus anterior plane block 0.4ml / kg bupivacaine 0.125% will be injected to open the space then a catheter will be advanced For continuous infusion of 0.0625 % bupivacaine at 7 ml / hour
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Serratus anterior plane block | Experimental | Procedure: Serratus anterior plane block20 patients will receive SAP block with 0.4 ml / kg bupivacaine 0.125% then continuous infusion through a catheter at rate of 7 ml / hour to max 10 ml / hour of bupivacaine 0.0625% |
| Thoracic Paravertebral block | Active comparator | Procedure: Thoracic Paravertebral block20 patients will receive TPVB 0.4ml / kg bupivacaine 0.125% then continuous infusion through a catheter at rate of 7 ml / hour to max 10 ml / hour of bupivacaine 0.0625% |
| Control group | Placebo comparator | Procedure: Control20 patients will receive Fentanyl patch 50 microgram |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- ASA 1_3 Age 18_60 Unilateral fracture ribs
Key exclusion criteria (1 listed)
- Drug allergy Morbid obese Opioid dependence Patients refuse
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 |
|---|---|---|
| Serratus anterior plane blockInjection of bupivacaine between serratus anterior plane and latissimus dorsi muscle using ultrasound | Procedure or surgery | Serratus anterior plane block |
| Thoracic Paravertebral blockInjection of bupivacaine in the thoracic Paravertebral space using ultrasound | Procedure or surgery | Thoracic Paravertebral block |
| ControlPlace a fentanyl patch 50 microgram | Procedure or surgery | Control group |
Primary outcome
VAS score
Time frame: 24 hour
Visual analogue pain score describe by the patient
1 secondary outcome
Total analgesic consumption
Time frame: 24 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2020.
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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.
Amany K Aboelhassan study chair
Minia University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Serratus anterior plane block and Thoracic Paravertebral block in people with Rib Fractures and Analgesia, run by Minia University 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 1 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 23 Sep 2020. 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. Some participants in this study may receive a placebo. 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 Ahmed G Shehata, Master (1067622270 ext. 0020, ahmedgamalicu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS score (time frame: 24 hour). 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 23 Sep 2020.