Serratus Anterior Plane BlockNCT04710823
Ultrasound- Guided Continuous Serratus Anterior Plane Block Versus Ultrasound- Guided Continuous Thoracic Paravertebral Block in Multiple Traumatic Rib Fractures.
A study testing Thoracic paravertebral block and Serratus anterior plane block in people with Serratus Anterior Plane Block and Thoracic Paravertebral Block, run by Tanta University at 1 site in Egypt.
Trial summary
The aim of this study is to compare the analgesic efficacy of ultrasound guided continuous SAP block and ultrasound guided continuous TPVB in patients with multiple traumatic rib fractures. Read more about this study
- Who is it for?
- Ages 22 to 65 years
- Conditions the study is for
- Serratus Anterior Plane Block, Thoracic Paravertebral Block, Ultrasound
- What is being tested?
- Thoracic paravertebral block and Serratus anterior plane block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 16 Jan 2021to 30 Apr 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 22 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of either gender aged between 22-65 years with unilateral traumatic multiple fracture ribs (≥ 3 fractured ribs).
Who cannot join
- • Contraindications to regional block such as patient's refusal, coagulopathy, local infection at the site of the block, known allergy to local anesthetic drugs and spinal deformity.
- Patients suffer from severe cardiovascular disease, hepatic or renal disease and patients with history of psychiatric illness.
- Patients had indications for mechanical ventilation on admission or during the study period.
- Patients had indications for immediate surgery for other associated injuries.
- Patients with hemodynamic instability.
- Patients having spine or pelvic fracture, traumatic brain injury, altered conscious level or spinal cord injury.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound- Guided Continuous Serratus Anterior Plane Block Versus Ultrasound- Guided Continuous Thoracic Paravertebral Block For Analgesia in Multiple Traumatic Rib Fractures.
The aim of this study is to compare the analgesic efficacy of ultrasound guided continuous SAP block and ultrasound guided continuous TPVB in patients with multiple traumatic rib fractures.
- Conditions
- Serratus Anterior Plane Block, Thoracic Paravertebral Block, Ultrasound, Multiple Traumatic Rib Fractures, Analgesia
- Being tested
- Thoracic paravertebral block, Serratus anterior plane block
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracic paravertebral blockProcedure or surgery
A bolus dose of 0.25% bupivacaine (0.3 ml/kg) will be injected slowly over 3-5 minutes. At 30 minutes after injection of the loading dose, the dermatomal loss of sensation to pinprick was tested. Patients who reported pain to pinprick will be considered to have a failed block and were excluded from the study. The block will be maintained by continuous infusion of bupivacaine 0.25% at a rate of 0.1 ml/kg/h via a syringe pump. The infusion will be continued for 4 days.
Serratus anterior plane blockProcedure or surgery
A bolus of 30 ml of 0.25% bupivacaine will be injected slowly over 3-5 minutes between latissmus dorsi muscle and serratus anterior muscle (Figure 15). Then a catheter was inserted through the Tuohy needle and advanced 3cm into the space and secured in place. At 30 minutes after injection of a loading dose, the dermatomal loss of sensation to pinprick will be tested. Patients who reported pain to pinprick will be considered to have a failed block and were excluded from the study. The block will be maintained by continuous infusion of bupivacaine 0.25% at a rate of 0.1 ml/kg/h via a syringe pump. The infusion was continued for 4 days.
| Study group | Role | What they receive |
|---|---|---|
| Thoracic paravertebral block | Experimental | Patients will receive ultrasound-guided continuous thoracic paravertebral blockusing bupivacaine 0.25% for 4 days. Receives: Procedure: Thoracic paravertebral block |
| Serratus anterior plane block | Experimental | Patients will receive ultrasound-guided continuous SAP block using bupivacaine 0.25% for 4 days. Receives: Procedure: Serratus anterior plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of pain scores
Pain will be assessed at rest and on coughing using the VAS on a scale from 0 (no pain) to 100 (worst pain) before the block, 30 minutes, 60 minutes after the block, and then every six hours for 4 days. But in order not to interrupt the sleeping pattern of patients, patients will be considered pain free (VAS= 0) if they will be at sleep with no tachypnea, tachycardia, or hypertension.
Measured: Four days after the block
Secondary outcomes (7)
Total consumption of morphine
Rescue analgesia will be provided with morphine (0.05 mg/kg) intravenously if visual analogue score (VAS) ≥ 40.
Measured: Four days after the block
Changes of forced vital capacity (FVC)
Forced vital capacity (FVC) will be assessed using bedside spirometry before the block, 30 minutes, 60 minutes after the blocks, and then every eight hours for 4 days
Measured: Four days after the block
Changes of forced expiratory volume in one second (FEV1)
Forced expiratory volume in one second (FEV1) will be assessed using bedside spirometry before the block, 30 minutes, 60 minutes after the blocks, and then every eight hours for 4 days
Measured: Four days after the block
Changes of forced expiratory volume in one second (FEV1)/forced vital capacity (FVC)
FEV1/FVC ratio will be assessed using bedside spirometry before the block, 30 minutes, 60 minutes after the blocks, and then every eight hours for 4 days
Measured: Four days after the block
Length of ICU stay
Length of ICU stay, defined as the time from admission to ICU to time of transfer to the surgical ward.
Measured: Four days after the block
Length of hospital stay
Measured: Four days after the block
Incidence of complications
Incidence of respiratory complications and mechanical ventilation
Measured: Four days after the block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2021
- Study start16 Jan 2021
- Primary completion25 Apr 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Serratus Anterior Plane BlockStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Osama Rehab, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04710823
- Sponsor's protocol ID
- 32596/09/18
- Status last verified
- Jan 2023
- First submitted
- 11 Jan 2021
- Last updated
- 11 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be available upon a reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound- Guided Continuous Serratus Anterior Plane Block Versus Ultrasound- Guided Continuous Thoracic Paravertebral Block For Analgesia in Multiple Traumatic Rib Fractures.
- ClinicalTrials.gov ID
- NCT04710823
- Acronym / sponsor ID
- 32596/09/18
- Conditions
- Serratus Anterior Plane Block, Thoracic Paravertebral Block, Ultrasound, Multiple Traumatic Rib Fractures, Analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 16 Jan 2021 (actual)
- Primary completion
- 25 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 15 Jan 2021 (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.
The aim of this study is to compare the analgesic efficacy of ultrasound guided continuous SAP block and ultrasound guided continuous TPVB in patients with multiple traumatic rib fractures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thoracic paravertebral block | Experimental | Procedure: Thoracic paravertebral blockPatients will receive ultrasound-guided continuous thoracic paravertebral blockusing bupivacaine 0.25% for 4 days. |
| Serratus anterior plane block | Experimental | Procedure: Serratus anterior plane blockPatients will receive ultrasound-guided continuous SAP block using bupivacaine 0.25% for 4 days. |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients of either gender aged between 22-65 years with unilateral traumatic multiple fracture ribs (≥ 3 fractured ribs).
Key exclusion criteria (6 listed)
- • Contraindications to regional block such as patient's refusal, coagulopathy, local infection at the site of the block, known allergy to local anesthetic drugs and spinal deformity.
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 |
|---|---|---|
| Thoracic paravertebral blockA bolus dose of 0.25% bupivacaine (0.3 ml/kg) will be injected slowly over 3-5 minutes. At 30 minutes after injection of the loading dose, the dermatomal loss of sensation to pinprick was tested. Patients who reported pain to pinprick will be considered to have a failed block and were excluded from the study. The block will be maintained by continuous infusion of bupivacaine 0.25% at a rate of 0.1 ml/kg/h via a syringe pump. The infusion will be continued for 4 days. | Procedure or surgery | Thoracic paravertebral block |
| Serratus anterior plane blockA bolus of 30 ml of 0.25% bupivacaine will be injected slowly over 3-5 minutes between latissmus dorsi muscle and serratus anterior muscle (Figure 15). Then a catheter was inserted through the Tuohy needle and advanced 3cm into the space and secured in place. At 30 minutes after injection of a loading dose, the dermatomal loss of sensation to pinprick will be tested. Patients who reported pain to pinprick will be considered to have a failed block and were excluded from the study. The block will be maintained by continuous infusion of bupivacaine 0.25% at a rate of 0.1 ml/kg/h via a syringe pump. The infusion was continued for 4 days. | Procedure or surgery | Serratus anterior plane block |
Primary outcome
Degree of pain scores
Time frame: Four days after the block
Pain will be assessed at rest and on coughing using the VAS on a scale from 0 (no pain) to 100 (worst pain) before the block, 30 minutes, 60 minutes after the block, and then every six hours for 4 days. But in order not to interrupt the sleeping pattern of patients, patients will be considered pain free (VAS= 0) if they will be at sleep with no tachypnea, tachycardia, or hypertension.
7 secondary outcomes
Total consumption of morphine
Time frame: Four days after the block
Changes of forced vital capacity (FVC)
Time frame: Four days after the block
Changes of forced expiratory volume in one second (FEV1)
Time frame: Four days after the block
Changes of forced expiratory volume in one second (FEV1)/forced vital capacity (FVC)
Time frame: Four days after the block
Length of ICU stay
Time frame: Four days after the block
Length of hospital stay
Time frame: Four days after the block
Incidence of complications
Time frame: Four days after the block
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2023.
- Individual participant dataSharing planned: Yes. Data will be available upon a reasonable request.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thoracic paravertebral block and Serratus anterior plane block in people with Serratus Anterior Plane Block and Thoracic Paravertebral Block, run by Tanta 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 6 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: finished, as of the sponsor's last update on 11 Jan 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of pain scores (time frame: Four days after the block). 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 11 Jan 2023.