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PEF-Block & Ribs Fractures (PEF)

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ClinicalTrials.gov Identifier: NCT03396692
Recruitment Status : Recruiting
First Posted : January 11, 2018
Last Update Posted : June 28, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Tracking Information
First Submitted Date  ICMJE December 15, 2017
First Posted Date  ICMJE January 11, 2018
Last Update Posted Date June 28, 2018
Actual Study Start Date  ICMJE June 18, 2018
Actual Primary Completion Date June 18, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 4, 2018)
Consumption of opoïd [ Time Frame: 24 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 4, 2018)
cough pain intensity [ Time Frame: 1 hour, 6hours, 12hours, 24hours ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PEF-Block & Ribs Fractures
Official Title  ICMJE PEF-Block & Ribs Fractures Effect of Posterior Exo-thoracic Fascia Block in the Pain Management of Ribs Fractures: a Prospective, Randomized Study
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chest Trauma With Ribs Fractures
Intervention  ICMJE
  • 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
  • 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.
  • 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.

Study Arms  ICMJE
  • Active Comparator: Control Arm
    Pain management use intravenous morphine patient-controlled analgesia (PCA)
    Intervention: Procedure: Intravenous morphine patient-controlled analgesia (PCA)
  • 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
    Intervention: Procedure: Block of the posterior exo-thoracic fascia with Ropivacaine
  • Experimental: Paravertebral block arm
    Pain management use intravenous morphine patient-controlled analgesia (PCA) and a block of paravertebral space with Ropivacaine
    Intervention: Procedure: Block of paravertebral space with Ropivacaine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 4, 2018)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 20, 2020
Actual Primary Completion Date June 18, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jonathan Charbit, MD +33467338256 j-charbit@chu-montpellier.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03396692
Other Study ID Numbers  ICMJE UF 9860
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University Hospital, Montpellier
Study Sponsor  ICMJE University Hospital, Montpellier
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University Hospital, Montpellier
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP