Rib FracturesNCT05160155
Comparison of the Analgesic Efficacy of Serratus Anterior Plane Block and Intercostal Block
A study testing Serratus Anterior Plane Block and Intercostal Block in people with Rib Fractures and Serratus Anterior Plane Block, run by Atatürk Chest Diseases and Chest Surgery Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
More than 50% of patients presenting with chest trauma experience rib fractures and these rib fractures are associated with significant morbidity, mortality, and long-term disability. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rib Fractures, Serratus Anterior Plane Block, Erector Spinae Plane Block
- What is being tested?
- Serratus Anterior Plane Block and Intercostal Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Dec 2021to 30 Dec 2022
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 65 years
- American Society of Anesthesiologists physical status I-II-III
- Body mass index between 18-30 kg/m2
- Patients with 6 or less rib fractures
Who cannot join
- Patient refusing the procedure
- History of chronic analgesic or opioid therapy
- History of local anesthetic allergy
- Infection in the intervention area
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Atatürk Chest Disease and Chest Surgery Training and Research Hospital
Keçiören, Ankara, 06000
About this study
Official title: Comparison of the Analgesic Efficacy of Serratus Anterior Plane Block and Intercostal Block for Rib Fractures
More than 50% of patients presenting with chest trauma experience rib fractures and these rib fractures are associated with significant morbidity, mortality, and long-term disability. Many of these adverse outcomes result from poorly controlled pain that interferes with breathing, leading to atelectasis, pneumonia, and respiratory failure. Therefore, early provision of adequate analgesia is crucial in the management of these patients. The basic stones of analgesic therapy are oral and intravenous drugs such as paracetamol, nonsteroidal anti-inflammatory drugs (NSAIDs), and opioids. However, patients with more significant injuries or comorbidities often require interventional procedures to provide adequate analgesia and avoid opioid-related side effects. Thoracic epidural analgesia and thoracic paravertebral blocks have traditionally been used, but these techniques are associated with side effects and may cause hemodynamic instability. Today, the use of ultrasonography (USG) guided block techniques such as erector spinae plane block (ESPB), serratus anterior plane block (SAPB) and intercostal block (ICB) has increased. These techniques are considered to be simpler and theoretically safer. Although ICB is frequently mentioned in the literature, the publications of new plane blocks such as ESPB and SAPB are new and few in number. In this study, SAPB and ICP to be performed with USG will be evaluated in terms of analgesic effect.
- Being tested
- Serratus Anterior Plane Block, Intercostal Block
- Keywords
- Rib Fractures, Serratus Anterior Plane Block, Erector Spinae Plane Block
- Medical subject headings
- Rib Fractures, Acute Pain
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
Serratus anterior plane block will be performed unilaterally, under US guidance.
Intercostal BlockProcedure or surgery
Intercostal Block will be performed unilaterally, under US guidance.
| Study group | Role | What they receive |
|---|---|---|
| Serratus Anterior Plane Block | Active comparator | Following the visualization of the anatomical structures, the nerve block needle will be advanced via the in-plane technique above the serratus anterior muscles until the interfascial space was reached. After hydrodissection with 2 ml normal saline, 20 ml 0.25% bupivacaine will be injected into the area. The block will be terminated. Receives: Procedure: Serratus Anterior Plane Block |
| Intercostal Block | Active comparator | The USG probe will be placed at the level of the posterior axillary line and the broken ribs. The ribs, external intercostal muscle, and internal intercostal muscle structures will be imaged. 3 ml of 0.25% bupivacaine will be injected into the subcostal area. This 3 ml 0.25% bupivacaine injection will be administered for each broken rib. The block will be terminated. Receives: Procedure: Intercostal Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain scores
Pain will be assessed at rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain). Pain assessment will be done at 1st, 2nd, 4th, 8th, 16th and 24th hours after surgery.
Measured: 24 hours after block
Secondary outcomes (1)
Need for additional analgesia
Whether the patients need additional analgesia after the block and the amount of additional analgesia needed will be recorded.
Measured: 24 hours after block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2021
- Study start3 Dec 2021
- Primary completion20 Dec 2022
- Study completion30 Dec 2022
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.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Musa Zengin, Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
- Investigators
- Musa Zengin, MD, Principal investigator, Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05160155
- Sponsor's protocol ID
- E.Kurul-E1-21-2143
- Status last verified
- Jan 2023
- First submitted
- 3 Dec 2021
- Last updated
- 10 Jan 2023
- Results posted
- No
- Data monitoring committee
- 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 10 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Analgesic Efficacy of Serratus Anterior Plane Block and Intercostal Block for Rib Fractures
- ClinicalTrials.gov ID
- NCT05160155
- Acronym / sponsor ID
- E.Kurul-E1-21-2143
- Keywords
- Rib Fractures, Serratus Anterior Plane Block, Erector Spinae Plane Block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Atatürk Chest Diseases and Chest Surgery Training and Research HospitalUniversity, hospital or other
- Study start
- 3 Dec 2021 (actual)
- Primary completion
- 20 Dec 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 16 Dec 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.
More than 50% of patients presenting with chest trauma experience rib fractures and these rib fractures are associated with significant morbidity, mortality, and long-term disability. Many of these adverse outcomes result from poorly controlled pain that interferes with breathing, leading to atelectasis, pneumonia, and respiratory failure. Therefore, early provision of adequate analgesia is crucial in the management of these patients. The basic stones of analgesic therapy are oral and intravenous drugs such as paracetamol, nonsteroidal anti-inflammatory drugs (NSAIDs), and opioids. However, patients with more significant injuries or comorbidities often require interventional procedures to provide adequate analgesia and avoid opioid-related side effects. Thoracic epidural analgesia and thoracic paravertebral blocks have traditionally been used, but these techniques are associated with side effects and may cause hemodynamic instability. Today, the use of ultrasonography (USG) guided block techniques such as erector spinae plane block (ESPB), serratus anterior plane block (SAPB) and intercostal block (ICB) has increased. These techniques are considered to be simpler and theoretically safer. Although ICB is frequently mentioned in the literature, the publications of new plane blocks such as ESPB and SAPB are new and few in number. In this study, SAPB and ICP to be performed with USG will be evaluated in terms of analgesic effect.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Serratus Anterior Plane Block | Active comparator | Procedure: Serratus Anterior Plane BlockFollowing the visualization of the anatomical structures, the nerve block needle will be advanced via the in-plane technique above the serratus anterior muscles until the interfascial space was reached. After hydrodissection with 2 ml normal saline, 20 ml 0.25% bupivacaine will be injected into the area. The block will be terminated. |
| Intercostal Block | Active comparator | Procedure: Intercostal BlockThe USG probe will be placed at the level of the posterior axillary line and the broken ribs. The ribs, external intercostal muscle, and internal intercostal muscle structures will be imaged. 3 ml of 0.25% bupivacaine will be injected into the subcostal area. This 3 ml 0.25% bupivacaine injection will be administered for each broken rib. The block will be terminated. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age between 18 and 65 years
- American Society of Anesthesiologists physical status I-II-III
- Body mass index between 18-30 kg/m2
- Patients with 6 or less rib fractures
Key exclusion criteria (4 listed)
- Patient refusing the procedure
- History of chronic analgesic or opioid therapy
- History of local anesthetic allergy
- Infection in the intervention area
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 BlockSerratus anterior plane block will be performed unilaterally, under US guidance. | Procedure or surgery | Serratus Anterior Plane Block |
| Intercostal BlockIntercostal Block will be performed unilaterally, under US guidance. | Procedure or surgery | Intercostal Block |
Primary outcome
Pain scores
Time frame: 24 hours after block
Pain will be assessed at rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain). Pain assessment will be done at 1st, 2nd, 4th, 8th, 16th and 24th hours after surgery.
1 secondary outcome
Need for additional analgesia
Time frame: 24 hours after 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 10 Jan 2023.
- Individual participant dataSharing planned: No
Related trials for Rib Fractures
RecruitingPhase 4
INTERCOSTAL NERVE BLOCK: Efficacy of CINB for Patients With Multiple Rib Fractures
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Erector Spinae Plane vs Serratus Anterior Plane Catheter Infusions for Acute Pain Management in Patients With Traumatic Rib Fractures
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Active, not recruiting
Effectiveness of an Innovative Chest Stabilizer in Rib Fracture Treatment: Impact on Respiratory Function, Complications, and Clinical Outcomes
Rib Fractures, Blunt Chest Trauma
Not yet recruitingPhase 2/3
Comparison of Dexmedetomidine Versus Dexamethasone as Adjuvants to Bupivacaine in Ultrasound-Guided Erector Spinae Plane Block for Acute Pain Management in Patients With Traumatic Rib Fractures
Rib Fractures, Acute Pain
RecruitingObservational study
GNRI and PNI for Predicting Short-Term Outcomes in Older Adults With Multiple Rib Fractures
Multiple Rib Fractures, Isolated Blunt Thoracic Trauma
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.
Musa Zengin, MD principal investigator
Atatürk Chest Diseases and Chest Surgery Training and Research 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 Intercostal Block in people with Rib Fractures and Serratus Anterior Plane Block, run by Atatürk Chest Diseases and Chest Surgery Training and Research Hospital at 1 site in Turkey (Türkiye).
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 4 inclusion and 4 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 10 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 Turkey (Türkiye). 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?
Pain scores (time frame: 24 hours after 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 10 Jan 2023.