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

Rib Fractures Clinical Trial

Official title: Comparison of Rib Fixation With Medical Analgesia in Patients With Uncomplicated Rib Fractures on Pain Control: a Multi-center Randomized Clinical Trial

Status Recruiting

Clinical Trial 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.

Clinical Trial 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, respectively, 59% and 76% of patients at two months, and in 22% and 53% of patients at 6 months. In a retrospective study including 216 patients with an isolated thoracic injury, only 34.2% of patients had a good recovery at one year and the six-month return to work rate is of 63%. Persistent pain and disability following rib fractures therefore result in a large psycho-socio-economic impact for health-care system. The only predictive factor for persistent pain and disability is the pain intensity within the first few days after injury. Similarly, the intensity of pain within the first days after thoracotomy predicts long-term post-thoracotomy pain. In a recent meta-analysis, epidural analgesia provides better acute pain relief than intravenous, paravertebral, and intercostal interventions. While meta-analyses conclude that operative fixation of complicated flail chest provide better outcome, the impact of surgery on pain in uncomplicated rib fracture is seldom studied. Some retrospective studies showed promising results of rib fixation with surgery in patients with uncomplicated rib fractures: A study showed that rib fixation reduced postoperative analgesic requirements. Similarly, another study showed that pain was significantly reduced one month after surgery as compared to a non-surgical approach. Finally, it has been recently observed a decreased mortality and respiratory complications after surgery in patients over 65 years old as well as a better functional status at two weeks, two months, and four months.

Trial objectives. No previous studies have provided definitive evidence for recommending rib fixation over simple pain medication to control pain. Our hypothesis is that a surgical approach may have further benefits as compared to a conservative treatment. The primary objective of the study is to compare pain two months after injury between two groups: group 1) patients who are treated with surgery and analgesic treatment; and group 2) patients who are treated with analgesic treatment alone. The secondary objective is to perform a longitudinal analysis over one year of the following parameters: amount of pain medication, quality of life, anxiety and depression, pulmonary capacity, return to work, and adverse events. Financial aspects are also investigated. ;

Related Conditions & MeSH terms

• Fractures, Bone
• Rib Fractures

• NCT number: NCT04745520
• Study type: Interventional
• Source: University Hospital, Geneva
• Contact: Benoît Bédat, MD
• Phone: +41795904475
• Email: benoit.bedat@hcuge.ch
• Status: Recruiting
• Phase: N/A
• Start date: March 12, 2021
• Completion date: March 2024