PEF-Block & Ribs Fractures (PEF)

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.

Study Overview

• Status: Completed
• Conditions: Chest Trauma With Ribs Fractures
• Intervention / Treatment: Procedure: Intravenous morphine patient-controlled analgesia (PCA); Procedure: Block of the posterior exo-thoracic fascia with Ropivacaine; Procedure: Block of paravertebral space with Ropivacaine

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • University Hospital Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Arm; Pain management use intravenous morphine patient-controlled analgesia (PCA)	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
Experimental: 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	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.
Experimental: Paravertebral block arm; 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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Consumption of opoïd	24 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
cough pain intensity	1 hour, 6hours, 12hours, 24hours

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): June 18, 2018
• Primary Completion (Actual): June 15, 2022
• Study Completion (Actual): June 15, 2022

Study Registration Dates

• First Submitted: December 15, 2017
• First Submitted That Met QC Criteria: January 4, 2018
• First Posted (Actual): January 11, 2018

Study Record Updates

• Last Update Posted (Actual): October 17, 2022
• Last Update Submitted That Met QC Criteria: October 14, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Thoracic Injuries; Fractures, Bone; Rib Fractures; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Analgesics, Opioid; Narcotics; Anesthetics, Local; Ropivacaine; Morphine
• Other Study ID Numbers: UF 9860

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No