Chest TraumaNCT03664973
Serratus Plane Block for Rib Fractures
A study testing Serratus plane block in people with Chest Trauma and Chest Pain, run by Azienda USL Reggio Emilia - IRCCS at 1 site in Italy.
Trial summary
Patients with ipsilateral multiple rib fractures will be randomized to receive either a single-shot ultrasound-guided serratus plane block, or a continuous serratus plane block within 24h from the chest trauma. Primary outcome is the difference in forced respiratory volume (FEV1) at 72h. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Chest Trauma, Chest Pain
- What is being tested?
- Serratus 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
- 0 participants
- Where
- 1 siteItaly
- Study dates
- 3 Sep 2018to 30 Dec 2023
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 2 o more ipsilateral rib fractures
- Trauma within 24h from hospital admission
- Informed consent
Who cannot join
- Chest drain
- head trauma
- bilateral rib fractures
- Intensive care admission
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of the Serratus Plane Block on the Outcome in Patient With Multiple Rib Fractures: A Prospective, Randomized, Controlled Trial
Patients with ipsilateral multiple rib fractures will be randomized to receive either a single-shot ultrasound-guided serratus plane block, or a continuous serratus plane block within 24h from the chest trauma. Primary outcome is the difference in forced respiratory volume (FEV1) at 72h.
Read the detailed description
Patients admitted in emergency department with a chest trauma and ipsilateral multiple rib fractures, will be randomized as described above. All patients will receive the serratus block with a ropivacaine 0.37% solution 20 ml. Then, they will randomized to receive either a peripheral catheter placed above the 5th rib on the middle axillary line, or nothing. In all patients postoperative analgesia also include Paracetamol 1g IV each 6h and a patient controlled analgesia (PCA) of morphine set out as follow: bolus 1 mg, loch out 15 min, max 4 boluses each hour. In all patients an arterial blood sample for gas analysis and a FEV1 will be achieved before the block, after 1 hour and at 72h.
- Conditions
- Chest Trauma, Chest Pain
- Being tested
- Serratus plane block
- Medical subject headings
- Thoracic Injuries, Chest Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serratus plane blockProcedure or surgery
Local anesthetic infusion though a peripheral nerve catheter placed on the 5th rib under the serratus plane
| Study group | Role | What they receive |
|---|---|---|
| continuous | Experimental | continuous local anesthetic infusion (ropivacaine 0.2%)on the serratus plane for at least 72h adds to a Single-shot serratus plane block with ropivacaine 0.37% solution 20 ml. Receives: Procedure: Serratus plane block |
| single-shot | Active comparator | Single-shot serratus plane block with ropivacaine 0.37% solution 20 ml Receives: Procedure: Serratus plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary change function
FEV 1
Measured: day 0 and day 3
Secondary outcomes (3)
Numerical rating scale (NRS) of pain
Pain both at rest and on movement on a 0-10 scale where 0 is the best and 10 the worst
Measured: day 0, day 1, day 2, day 3, day 4
Morphine
morphine requirement
Measured: day 0, day 1, day 2, day 3, day 4
hospital stay
time to fill the discharge criteria
Measured: day 1, day 2, day 3, day 4, day 5, day 6, day7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2018
- Study start3 Sep 2018
- Primary completion30 Dec 2023
- Study completion30 Dec 2023
Why it stopped: study never started
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chest TraumaStudies 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
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCS
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03664973
- Sponsor's protocol ID
- Serratus GC
- Status last verified
- May 2019
- First submitted
- 2 Sep 2018
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Serratus Plane Block on the Outcome in Patient With Multiple Rib Fractures: A Prospective, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT03664973
- Acronym / sponsor ID
- Serratus GC
- Conditions
- Chest Trauma, Chest Pain
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: study never started
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCSOther government
- Study start
- 3 Sep 2018 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 11 Sep 2018 (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.
Patients with ipsilateral multiple rib fractures will be randomized to receive either a single-shot ultrasound-guided serratus plane block, or a continuous serratus plane block within 24h from the chest trauma. Primary outcome is the difference in forced respiratory volume (FEV1) at 72h.
Detailed description
Patients admitted in emergency department with a chest trauma and ipsilateral multiple rib fractures, will be randomized as described above. All patients will receive the serratus block with a ropivacaine 0.37% solution 20 ml. Then, they will randomized to receive either a peripheral catheter placed above the 5th rib on the middle axillary line, or nothing. In all patients postoperative analgesia also include Paracetamol 1g IV each 6h and a patient controlled analgesia (PCA) of morphine set out as follow: bolus 1 mg, loch out 15 min, max 4 boluses each hour. In all patients an arterial blood sample for gas analysis and a FEV1 will be achieved before the block, after 1 hour and at 72h.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| continuous | Experimental | Procedure: Serratus plane blockcontinuous local anesthetic infusion (ropivacaine 0.2%)on the serratus plane for at least 72h adds to a Single-shot serratus plane block with ropivacaine 0.37% solution 20 ml. |
| single-shot | Active comparator | Procedure: Serratus plane blockSingle-shot serratus plane block with ropivacaine 0.37% solution 20 ml |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 2 o more ipsilateral rib fractures
- Trauma within 24h from hospital admission
- Informed consent
Key exclusion criteria (4 listed)
- Chest drain
- head trauma
- bilateral rib fractures
- Intensive care admission
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 plane blockLocal anesthetic infusion though a peripheral nerve catheter placed on the 5th rib under the serratus plane | Procedure or surgery | continuous, single-shot |
Primary outcome
Pulmonary change function
Time frame: day 0 and day 3
FEV 1
3 secondary outcomes
Numerical rating scale (NRS) of pain
Time frame: day 0, day 1, day 2, day 3, day 4
Morphine
Time frame: day 0, day 1, day 2, day 3, day 4
hospital stay
Time frame: day 1, day 2, day 3, day 4, day 5, day 6, day7
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
- Individual participant dataSharing planned: Undecided
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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 Serratus plane block in people with Chest Trauma and Chest Pain, run by Azienda USL Reggio Emilia - IRCCS at 1 site in Italy.
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 3 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: withdrawn, as of the sponsor's last update on 25 Jun 2025. 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 Italy. 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 was withdrawn before enrolling participants, so there are no results.
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?
Pulmonary change function (time frame: day 0 and day 3). 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 25 Jun 2025.