PEF-Block & Ribs Fractures

NCT ID: NCT03396692

Last Updated: 2022-10-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-18
• Study Completion Date: 2022-06-15

Brief 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.

Conditions

Chest Trauma With Ribs Fractures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control Arm

Pain management use intravenous morphine patient-controlled analgesia (PCA)

Group Type: ACTIVE_COMPARATOR

Intravenous morphine patient-controlled analgesia (PCA)

Intervention Type: PROCEDURE

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

Posterior exo-thoracic fascia block arm

Pain management use intravenous morphine patient-controlled analgesia (PCA) and a block of the posterior exo-thoracic fascia with Ropivacaine

Group Type: EXPERIMENTAL

Block of the posterior exo-thoracic fascia with Ropivacaine

Intervention Type: PROCEDURE

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.

Paravertebral block arm

Pain management use intravenous morphine patient-controlled analgesia (PCA) and a block of paravertebral space with Ropivacaine

Group Type: EXPERIMENTAL

Block of paravertebral space with Ropivacaine

Intervention Type: PROCEDURE

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.

Interventions

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

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Hospital Center

Montpellier, , France

Countries

France

Other Identifiers

UF 9860

Identifier Type: -

Identifier Source: org_study_id