An interventional study of Intravenous morphine patient-controlled analgesia (PCA) and Block of the posterior exo-thoracic fascia with Ropivacaine in Chest Trauma With Ribs Fractures, sponsored by University Hospital, Montpellier. Completed at 1 site in France. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-10-17.
Sponsored by University Hospital, Montpellier · Not applicable, Interventional, and Treatment
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.
126 studies on the registry are indexed under Rib Fractures; 28 are open to participants now.
This study's enrollment of 90 is above the median of 60 across 92 interventional studies indexed under Rib Fractures.
Browse Rib Fractures studies →University Hospital, Montpellier is the lead sponsor of 1,261 studies on the registry; 224 are open to participants now.
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Exclusion Criteria:
Pain management use intravenous morphine patient-controlled analgesia (PCA)
Procedure: Intravenous morphine patient-controlled analgesia (PCA)
Pain management use intravenous morphine patient-controlled analgesia (PCA) and a block of the posterior exo-thoracic fascia with Ropivacaine
Procedure: Block of the posterior exo-thoracic fascia with Ropivacaine
Pain management use intravenous morphine patient-controlled analgesia (PCA) and a block of paravertebral space with Ropivacaine
Procedure: Block of paravertebral space with Ropivacaine
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
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.
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.
Consumption of opoïd
Time frame: 24 hours
cough pain intensity
Time frame: 1 hour, 6hours, 12hours, 24hours
Plan to share: No
No publications or documents are linked to this record.
Ran from Jun 2018 to primary completion in Jun 2022, 47 months.
Of 41 non-industry interventional studies with no phase under Rib Fractures, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 37. This study's 47 months is above that.
Counting every sponsor, half of 41 studies reached it within 23 months; a quarter within 15 and three quarters within 37.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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