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Trial record 19 of 20 for:    Recruiting, Not yet recruiting, Available Studies | Pain | Neurostimulation

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

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.

Condition or disease Intervention/treatment Phase
Chest Trauma With Ribs Fractures Procedure: Intravenous morphine patient-controlled analgesia (PCA) Procedure: Block of the posterior exo-thoracic fascia with Ropivacaine Procedure: Block of paravertebral space with Ropivacaine Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: PEF-Block & Ribs Fractures Effect of Posterior Exo-thoracic Fascia Block in the Pain Management of Ribs Fractures: a Prospective, Randomized Study
Actual Study Start Date : June 18, 2018
Actual Primary Completion Date : June 18, 2018
Estimated Study Completion Date : December 20, 2020

Resource links provided by the National Library of Medicine


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.





Primary Outcome Measures :
  1. Consumption of opoïd [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. cough pain intensity [ Time Frame: 1 hour, 6hours, 12hours, 24hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03396692


Contacts
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Contact: Jonathan Charbit, MD +33467338256 j-charbit@chu-montpellier.fr

Locations
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France
University Hospital Center Recruiting
Montpellier, France, 34295
Contact: CHARBY Jonathan, MD    04 67 33 86 61    j-charbit@chu-montpellier.fr   
Sponsors and Collaborators
University Hospital, Montpellier

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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT03396692     History of Changes
Other Study ID Numbers: UF 9860
First Posted: January 11, 2018    Key Record Dates
Last Update Posted: June 28, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fractures, Bone
Rib Fractures
Wounds and Injuries
Thoracic Injuries
Morphine
Ropivacaine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Local
Anesthetics