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Completed

NCT Number: NCT03396692

PEF-Block & Ribs Fractures

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.

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Key information

Conditions

Chest Trauma With Ribs Fractures

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Center

Montpellier, 34295, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intravenous morphine patient-controlled analgesia (PCA)

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

Block of the posterior exo-thoracic fascia with Ropivacaine

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.

Block of paravertebral space with Ropivacaine

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.

Primary outcomes

  1. Consumption of opoïd

    Time frame: 24 hours

Secondary outcomes

  1. cough pain intensity

    Time frame: 1 hour, 6hours, 12hours, 24hours

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

PEF-Block & Ribs Fractures Effect of Posterior Exo-thoracic Fascia Block in the Pain Management of Ribs Fractures: a Prospective, Randomized Study

Acronym: PEF

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Jan 11, 2018
Registry last updated
Oct 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.