Randomized Clinical Trial of Rib Fixation Versus Medical Analgesia in Uncomplicated Rib Fractures on Pain Control.

• Status: Recruiting
• Trial end date: 2024-03-01
• Target enrollment: 0
• Participant gender: All

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 impact of costal fractures on quality of life is underestimated. The socio-psycho-economic consequences are substantial.

Previous studies have shown that an important factor for persistent pain and functional disability is the intensity of the initial pain. However, preliminary studies have shown promising results with surgical fixation of rib fractures: reduced need for analgesic drugs, reduced pain at 1 month, reduced complications and improved motor skills in patients over 65 years of age.

To date, the only clinical trials that exist focused on the fixation of complicated rib dislocations. While fixation of uncomplicated rib fractures is a common practice, no randomized studies have been conducted to evaluate its impact on pain and quality of life in the medium and long term.

In this context, the aim of our randomized study is to compare pain at 2 months between operated and non-operated patients with uncomplicated rib fractures.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Benoît Bédat
• Collaborators: Centre Hospitalier Universitaire Vaudois; Hôpital du Valais

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.