PEF-Block & Ribs Fractures

Chest Trauma With Ribs Fractures Clinical Trial

— PEF  

Official title:

PEF-Block & Ribs Fractures Effect of Posterior Exo-thoracic Fascia Block in the Pain Management of Ribs Fractures: a Prospective, Randomized Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03396692
• Other study ID #: UF 9860
• Status: Completed
• Phase: N/A
• Start date: June 18, 2018
• Est. completion date: June 15, 2022

Study information

• Verified date: October 2022
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: June 15, 2022
• Est. primary completion date: June 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Minor patients,
• Patients under guardianship
• Pregnant or lactating women
• Allergy known to local anesthetics,
• Severe coagulopathy,
• Infection of the puncture site
• Neuromuscular pathology
• Chronic pain patients (long-term treatment with non-inflammatory steroidal, opioid, neuroleptic, antidepressant, antiepileptic),
• Intubated patient

Related Conditions & MeSH terms

• Chest Trauma With Ribs Fractures
• Fractures, Bone
• Rib Fractures

Intervention

Procedure:
• 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
• Block of the posterior exo-thoracic fascia with Ropivacaine
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 Ropivacaine
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.

Locations

Country	Name	City	State
France	University Hospital Center	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Consumption of opoïd		24 hours
Secondary	cough pain intensity		1 hour, 6hours, 12hours, 24hours