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PEF-Block & Ribs Fractures (PEF)

Primary Purpose

Chest Trauma With Ribs Fractures

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Intravenous morphine patient-controlled analgesia (PCA)
Block of the posterior exo-thoracic fascia with Ropivacaine
Block of paravertebral space with Ropivacaine
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chest Trauma With Ribs Fractures

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Control Arm

Posterior exo-thoracic fascia block arm

Paravertebral block arm

Arm Description

Pain management use 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

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

Outcomes

Primary Outcome Measures

Consumption of opoïd

Secondary Outcome Measures

cough pain intensity

Full Information

First Posted
December 15, 2017
Last Updated
October 14, 2022
Sponsor
University Hospital, Montpellier
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1. Study Identification

Unique Protocol Identification Number
NCT03396692
Brief Title
PEF-Block & Ribs Fractures
Acronym
PEF
Official Title
PEF-Block & Ribs Fractures Effect of Posterior Exo-thoracic Fascia Block in the Pain Management of Ribs Fractures: a Prospective, Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
June 18, 2018 (Actual)
Primary Completion Date
June 15, 2022 (Actual)
Study Completion Date
June 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chest Trauma With Ribs Fractures

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Arm
Arm Type
Active Comparator
Arm Description
Pain management use intravenous morphine patient-controlled analgesia (PCA)
Arm Title
Posterior exo-thoracic fascia block arm
Arm Type
Experimental
Arm Description
Pain management use intravenous morphine patient-controlled analgesia (PCA) and a block of the posterior exo-thoracic fascia with Ropivacaine
Arm Title
Paravertebral block arm
Arm Type
Experimental
Arm Description
Pain management use intravenous morphine patient-controlled analgesia (PCA) and a block of paravertebral space with Ropivacaine
Intervention Type
Procedure
Intervention Name(s)
Intravenous morphine patient-controlled analgesia (PCA)
Intervention Description
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
Intervention Name(s)
Block of the posterior exo-thoracic fascia with Ropivacaine
Intervention Description
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
Intervention Name(s)
Block of paravertebral space with Ropivacaine
Intervention Description
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 Measure Information:
Title
Consumption of opoïd
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
cough pain intensity
Time Frame
1 hour, 6hours, 12hours, 24hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
University Hospital Center
City
Montpellier
ZIP/Postal Code
34295
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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PEF-Block & Ribs Fractures

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