Chest Trauma With Ribs FracturesPEFNCT03396692
PEF-Block & Ribs Fractures
A study testing Block of the posterior exo-thoracic fascia with Ropivacaine and Block of paravertebral space with Ropivacaine in people with Chest Trauma With Ribs Fractures, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Rib fractures are frequent injuries found approximately in 10% severe trauma patient. Rib fractures were correlated in many studies with a higher morbidity and mortality. This impaired outcome is mainly due to pulmonary complications consequences including especially pulmonary contusions. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chest Trauma With Ribs Fractures
- What is being tested?
- Block of the posterior exo-thoracic fascia with Ropivacaine and Block of paravertebral space with Ropivacaine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- 18 Jun 2018to 15 Jun 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Major patients (18-80 years old)
- Affiliated to the social security
- Hospitalized following severe trauma associated with at least 2 unilateral ribs fractures
- EVA greater than or equal to 3 when coughing or when mobilizing care.
- Management of the patient in the first 24 hours post trauma.
- Patient not intubated.
- Collection of informed written consent, notification on the anesthesia sheet.
Who cannot join
- Minor patients,
- Patients under guardianship
- Pregnant or lactating women
- Allergy known to local anesthetics,
- Severe coagulopathy,
- Infection of the puncture site
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- Neuromuscular pathology
- Chronic pain patients (long-term treatment with non-inflammatory steroidal, opioid, neuroleptic, antidepressant, antiepileptic),
- Intubated patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PEF-Block & Ribs Fractures Effect of Posterior Exo-thoracic Fascia Block in the Pain Management of Ribs Fractures: a Prospective, Randomized Study
Rib fractures are frequent injuries found approximately in 10% severe trauma patient. Rib fractures were correlated in many studies with a higher morbidity and mortality. This impaired outcome is mainly due to pulmonary complications consequences including especially pulmonary contusions. Frequently, patients present difficulty deep breathing and coughing. These adverse effects can lead to the development of atelectasis, hypoxia, and respiratory failure with mechanic ventilation recourse. Effective pain management may prevent these complications and reduce the likelihood of developing chronic pain. A multi-modal analgesia regimen is widely employed combining regional and systemic analgesia. Epidural analgesia is considered by many authors to be the gold standard of pain relief although many side-effects are frequently describe including hypotension, urinary retention nausea and vomiting. Paravertebral nerve blockade is an adequate alternative that provide similar quality of analgesia with lower incidence of complication. However, the failure rate associates with PVB is about 13% and it may be associated with hypotension (4.6%), accidental vascular puncture (3.8%), accidental pleural puncture (1.1%) and rarely pneumothorax (0.5%). Recently, a description of the intercostal paraspinal nerve block. This technic was performed for patients undergoing thoracic surgery without complications.More recently, a description of a new approach to provide thoracic analgesia named the Posterior Paramedian subchoroidal (PoPS) block. The authors consider this technique provide an analgesia of the anterior and the posterior branch of adjacent thoracic nerves. The investigators propose to investigate the effect of Posterior exothoracic fascial block.
- Conditions
- Chest Trauma With Ribs Fractures
- Being tested
- Intravenous morphine patient-controlled analgesia (PCA), Block of the posterior exo-thoracic fascia with Ropivacaine, Block of paravertebral space with Ropivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous morphine patient-controlled analgesia (PCA)Procedure or surgery
Group 1 control:
- Morphine titration at 0.1 mg/kg
- Establishment of PCA morphine:
- concentration 1mg/ml
- 1ml bolus
- refractory period of 7 minutes
- no maximum dose per day. Premedication of the patient with Ketamine 0.15 mg/kg and Propofol 0.5 mg /kg
Block of the posterior exo-thoracic fascia with RopivacaineProcedure or surgery
Group 2 PEF block:
- Establishment of PCA morphine:
- concentration 1mg / ml
- 1ml bolus
- refractory period of 7 minutes
- no maximum dose per day.
- Realization of a block of the posterior exo-thoracic fascia (PEF block) at the median level of ribs fractures with ropivacaine 5mg / mL, 3 mg / kg under echography guidance. ALR needle (type neurostimulation) with a length of 100 mm is used. When the injection is performed an analgesia catheter is deposited in the space created by local anesthetics. Realization of ropivacaine bolus 2mg / ml at 0.1ml/kg every 4 hours. Possibility of an additional bolus of 0.1ml / kg every hour if insufficient analgesia.
Block of paravertebral space with RopivacaineProcedure or surgery
Group 3 paravertebral block:
- Establishment of PCA morphine:
- concentration 1mg / ml
- 1ml bolus
- refractory period of 7 minutes
- no maximum dose per day.
- Realization of a paravertebral block (BPV) at the median level of ribs fractures ropivacaine 5mg / mL, (0.3ml / kg) 1.5 mg / kg under echography guidance. ALR needle (type neurostimulation) with a length of 100 mm is used. When the injection is performed an analgesia catheter is deposited in the space created by local anesthetics. Realization of bolus of ropivacaine 2mg / ml at 0.1ml / kg every 4 hours.
Possibility of an additional bolus of 0.1ml / kg every hour if insufficient analgesia.
In the case of failure of initial management with significant pain despite the iterative boli, epidural analgesia is used in recourse.
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | Active comparator | Pain management use intravenous morphine patient-controlled analgesia (PCA) Receives: Procedure: Intravenous morphine patient-controlled analgesia (PCA) |
| Posterior exo-thoracic fascia block arm | Experimental | Pain management use intravenous morphine patient-controlled analgesia (PCA) and a block of the posterior exo-thoracic fascia with Ropivacaine Receives: Procedure: Block of the posterior exo-thoracic fascia with Ropivacaine |
| Paravertebral block arm | Experimental | Pain management use intravenous morphine patient-controlled analgesia (PCA) and a block of paravertebral space with Ropivacaine Receives: Procedure: Block of paravertebral space with Ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Consumption of opoïd
Measured: 24 hours
Secondary outcomes (1)
cough pain intensity
Measured: 1 hour, 6hours, 12hours, 24hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2018
- Study start18 Jun 2018
- Primary completion15 Jun 2022
- Study completion15 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chest Trauma With Ribs 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
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03396692
- Sponsor's protocol ID
- UF 9860
- Acronym
- PEF
- Status last verified
- Oct 2022
- First submitted
- 15 Dec 2017
- Last updated
- 17 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ramin S, Charbit J, Airoldi F, Courvallin E, Dagod G, Herteleer M, Choquet O, Bringuier S, Capdevila X. Continuous posterior extrathoracic fascial plane block versus continuous paravertebral block for pain management in patients with multiple rib fractures: a randomised controlled noninferiority trial. Br J Anaesth. 2026 Feb;136(2):677-686. doi: 10.1016/j.bja.2025.09.058. Epub 2025 Nov 20.
PubMed 41271472
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PEF-Block & Ribs Fractures Effect of Posterior Exo-thoracic Fascia Block in the Pain Management of Ribs Fractures: a Prospective, Randomized Study
- ClinicalTrials.gov ID
- NCT03396692
- Acronym / sponsor ID
- PEF / UF 9860
- Conditions
- Chest Trauma With Ribs Fractures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 18 Jun 2018 (actual)
- Primary completion
- 15 Jun 2022 (actual)
- Study completion
- 15 Jun 2022 (actual)
- First posted
- 11 Jan 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.
Rib fractures are frequent injuries found approximately in 10% severe trauma patient. Rib fractures were correlated in many studies with a higher morbidity and mortality. This impaired outcome is mainly due to pulmonary complications consequences including especially pulmonary contusions. Frequently, patients present difficulty deep breathing and coughing. These adverse effects can lead to the development of atelectasis, hypoxia, and respiratory failure with mechanic ventilation recourse. Effective pain management may prevent these complications and reduce the likelihood of developing chronic pain. A multi-modal analgesia regimen is widely employed combining regional and systemic analgesia. Epidural analgesia is considered by many authors to be the gold standard of pain relief although many side-effects are frequently describe including hypotension, urinary retention nausea and vomiting. Paravertebral nerve blockade is an adequate alternative that provide similar quality of analgesia with lower incidence of complication. However, the failure rate associates with PVB is about 13% and it may be associated with hypotension (4.6%), accidental vascular puncture (3.8%), accidental pleural puncture (1.1%) and rarely pneumothorax (0.5%). Recently, a description of the intercostal paraspinal nerve block. This technic was performed for patients undergoing thoracic surgery without complications.More recently, a description of a new approach to provide thoracic analgesia named the Posterior Paramedian subchoroidal (PoPS) block. The authors consider this technique provide an analgesia of the anterior and the posterior branch of adjacent thoracic nerves. The investigators propose to investigate the effect of Posterior exothoracic fascial block.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Arm | Active comparator | Procedure: Intravenous morphine patient-controlled analgesia (PCA)Pain management use intravenous morphine patient-controlled analgesia (PCA) |
| Posterior exo-thoracic fascia block arm | Experimental | Procedure: Block of the posterior exo-thoracic fascia with RopivacainePain management use intravenous morphine patient-controlled analgesia (PCA) and a block of the posterior exo-thoracic fascia with Ropivacaine |
| Paravertebral block arm | Experimental | Procedure: Block of paravertebral space with RopivacainePain management use intravenous morphine patient-controlled analgesia (PCA) and a block of paravertebral space with Ropivacaine |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Major patients (18-80 years old)
- Affiliated to the social security
- Hospitalized following severe trauma associated with at least 2 unilateral ribs fractures
- EVA greater than or equal to 3 when coughing or when mobilizing care.
- Management of the patient in the first 24 hours post trauma.
Key exclusion criteria (9 listed)
- Minor patients,
- Patients under guardianship
- Pregnant or lactating women
- Allergy known to local anesthetics,
- Severe coagulopathy,
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 |
|---|---|---|
| Intravenous morphine patient-controlled analgesia (PCA)Group 1 control: * Morphine titration at 0.1 mg/kg * Establishment of PCA morphine: * concentration 1mg/ml * 1ml bolus * refractory period of 7 minutes * no maximum dose per day. Premedication of the patient with Ketamine 0.15 mg/kg and Propofol 0.5 mg /kg | Procedure or surgery | Control Arm |
| Block of the posterior exo-thoracic fascia with RopivacaineGroup 2 PEF block: * Establishment of PCA morphine: * concentration 1mg / ml * 1ml bolus * refractory period of 7 minutes * no maximum dose per day. * Realization of a block of the posterior exo-thoracic fascia (PEF block) at the median level of ribs fractures with ropivacaine 5mg / mL, 3 mg / kg under echography guidance. ALR needle (type neurostimulation) with a length of 100 mm is used. When the injection is performed an analgesia catheter is deposited in the space created by local anesthetics. Realization of ropivacaine bolus 2mg / ml at 0.1ml/kg every 4 hours. Possibility of an additional bolus of 0.1ml / kg every hour if insufficient analgesia. | Procedure or surgery | Posterior exo-thoracic fascia block arm |
| Block of paravertebral space with RopivacaineGroup 3 paravertebral block: * Establishment of PCA morphine: * concentration 1mg / ml * 1ml bolus * refractory period of 7 minutes * no maximum dose per day. * Realization of a paravertebral block (BPV) at the median level of ribs fractures ropivacaine 5mg / mL, (0.3ml / kg) 1.5 mg / kg under echography guidance. ALR needle (type neurostimulation) with a length of 100 mm is used. When the injection is performed an analgesia catheter is deposited in the space created by local anesthetics. Realization of bolus of ropivacaine 2mg / ml at 0.1ml / kg every 4 hours. Possibility of an additional bolus of 0.1ml / kg every hour if insufficient analgesia. In the case of failure of initial management with significant pain despite the iterative boli, epidural analgesia is used in recourse. | Procedure or surgery | Paravertebral block arm |
Primary outcome
Consumption of opoïd
Time frame: 24 hours
1 secondary outcome
cough pain intensity
Time frame: 1 hour, 6hours, 12hours, 24hours
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 17 Oct 2022.
- Derived from this study: PubMed 41271472Ramin S, Charbit J, Airoldi F, Courvallin E, Dagod G, Herteleer M, Choquet O, Bringuier S, Capdevila X. Continuous posterior extrathoracic fascial plane block versus continuous paravertebral block for pain management in patients with multiple rib fractures: a randomised controlled noninferiority trial. Br J Anaesth. 2026 Feb;136(2):677-686. doi: 10.1016/j.bja.2025.09.058. Epub 2025 Nov 20.
- 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.
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 Block of the posterior exo-thoracic fascia with Ropivacaine and Block of paravertebral space with Ropivacaine in people with Chest Trauma With Ribs Fractures, run by University Hospital, Montpellier at 1 site in France.
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 7 inclusion and 9 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 17 Oct 2022. 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 France. 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?
Consumption of opoïd (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03396692, which also lists 1 linked publication.
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 17 Oct 2022.