Status:
TERMINATED
Randomized Clinical Trial of Rib Fixation Versus Medical Analgesia in Uncomplicated Rib Fractures on Pain Control.
Lead Sponsor:
Benoît Bédat
Collaborating Sponsors:
Centre Hospitalier Universitaire Vaudois
Hôpital du Valais
Conditions:
Rib Fractures
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Uncomplicated costal fractures often result in persistent pain over the long term. Indeed, cohort studies showed that at 6 months, 22% of patients still had pain and 56% had functional disability. The...
Detailed Description
Background. Until recently, functional disability and chronic pain and following uncomplicated rib fractures have been scarcely studied. Studies described persistent pain and disability in, respective...
Eligibility Criteria
Inclusion
- At least 2 rib fractures
- At least 1 dislocated rib fracture
- Fractures accessible to surgery
- Thoracic trauma no more than two days prior to screening for inclusion
- Thoracic epidural analgesia
- Written informed consent
Exclusion
- Any other concomitant fractures excepted clavicle fracture
- Respiratory distress syndrome according to the Berlin definition
- Presence of \>1.5 liter of blood drained from the pleural space
- Hemostasis disorder defined by any of the following criteria:
- Platelet count \< 70'000/mm3,
- International Normalized Ratio (INR) \> 1.2 (Prothrombin \< 70%)
- activated partial thromboplastin time (aPTT) ≥ 60 seconds
- drugs such as: P2Y12 antagonists (clopidogrel, prasugrel) and glycoprotein IIb/IIIa antagonists (abciximab, tirofiban)
- Pathological rib fracture due to metastasis
- Hemodynamic instability: systolic blood pressure \< 100 mmHg and heart rate \> 100 beats per minute
- Neurologic disorder: Glasgow Coma Score \< 13 in the initial 24 hours, or intracerebral, epidural, subdural, or subarachnoid hemorrhages, or cerebral contusion
- Titanium allergy
- Known or suspected non-compliance to medical therapy due to drug or alcohol abuse
- Age \<18 years old
- Women who know they are pregnant or breast feeding
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc.
Key Trial Info
Start Date :
March 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 16 2024
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT04745520
Start Date
March 12 2021
End Date
September 16 2024
Last Update
January 20 2025
Active Locations (1)
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1
Unit of Thoracic and Endocrine Surgery, University Hospitals of Geneva
Geneva, Switzerland, 1205