Clinical trial NCT04745520: Randomized Clinical Trial of Rib Fixation Versus Medical Analgesia in Uncomplicated Rib Fractures on Pain Control.
Official title: Comparison of Rib Fixation with Medical Analgesia in Patients with Uncomplicated Rib Fractures on Pain Control: a Multi-center Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Rib Fractures
Keywords: thoracic trauma
rib fixation
medical device
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier Universitaire Vaudois
name: Hôpital du Valais
First posted: 2021-02-09
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This pragmatic trial is a multi-center, two-arm, parallel-group, superiority randomized-controlled trial.
Primary purpose: TREATMENT

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 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.

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, 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.

Eligibility 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.

Primary outcomes:
measure: Pain severity
timeFrame: Two months after injury
Secondary outcomes:
measure: Pain severity
timeFrame: At recruitment (baseline)
measure: Pain severity
timeFrame: One month after injury
measure: Pain severity
timeFrame: Three months after injury
measure: Pain severity
timeFrame: Six months after injury
measure: Pain severity
timeFrame: Twelve months after injury
measure: Anxiety and Depression.
timeFrame: At recruitment (baseline)
measure: Anxiety and Depression.
timeFrame: One month after injury
measure: Anxiety and Depression.
timeFrame: Two months after injury
measure: Neuropathic pain
timeFrame: Two months after injury
measure: Neuropathic pain
timeFrame: Six months after injury
measure: Pain interference
timeFrame: At recruitment (baseline)
measure: Pain interference
timeFrame: One month after injury
measure: Pain interference
timeFrame: Two months after injury
measure: Pain interference
timeFrame: Three months after injury
measure: Pain interference
timeFrame: Six months after injury
measure: Pain interference
timeFrame: Twelve months after injury
measure: Health and well being
timeFrame: At recruitment (baseline)
measure: Health and well being
timeFrame: Two months after injury
measure: Health and well being
timeFrame: Six months after injury
measure: Analgesic medication during hospitalisation
timeFrame: At recruitement (baseline)
measure: Analgesic medication at home
timeFrame: One month after injury
measure: Analgesic medication at home
timeFrame: Two months after injury
measure: Analgesic medication at home
timeFrame: Three months after injury
measure: Analgesic medication at home
timeFrame: Six months after injury
measure: Analgesic medication at home
timeFrame: Twelve months after injury
measure: Productivity & return to work
timeFrame: One month after injury
measure: Productivity & return to work
timeFrame: Two months after injury
measure: Productivity & return to work
timeFrame: Three months after injury
measure: Productivity & return to work
timeFrame: Six months after injury
measure: Productivity & return to work
timeFrame: Twelve months after injury
measure: Pulmonary function
timeFrame: Two months after injury
measure: Pulmonary function, forced vital capacity
timeFrame: Six months after injury
measure: Pulmonary function, peak expiratory flow
timeFrame: Two months after injury
measure: Pulmonary function, peak expiratory flow
timeFrame: Six months after injury
measure: Pulmonary function, sniff nasal inspiratory pressure
timeFrame: Two months after injury
measure: Pulmonary function, sniff nasal inspiratory pressure
timeFrame: Six months after injury
measure: Pulmonary function, inspiratory pressure
timeFrame: Two months after injury
measure: Pulmonary function, inspiratory pressure
timeFrame: Six months after injury
measure: Length of hospital stay
timeFrame: from admission to discharge, up to four weeks
measure: Total costs
timeFrame: Twelve months after injury
measure: Adverse events
timeFrame: From inclusion to the end of the study, up to 12 months
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Unit of Thoracic and Endocrine Surgery, University Hospitals of Geneva
Study officials:
affiliation: University Hospital, Geneva
name: Benoît Bédat, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Geneva
name: Frédéric Triponez, Prof.
role: STUDY_CHAIR
References:
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citation: Peek J, Smeeing DPJ, Hietbrink F, Houwert RM, Marsman M, de Jong MB. Comparison of analgesic interventions for traumatic rib fractures: a systematic review and meta-analysis. Eur J Trauma Emerg Surg. 2019 Aug;45(4):597-622. doi: 10.1007/s00068-018-0918-7. Epub 2018 Feb 6.
citation: Perentes JY, Christodoulou M, Abdelnour-Berchtold E, Karenovics W, Gayet-Ageron A, Gonzalez M, Krueger T, Triponez F, Terrier P, Bedat B. Effectiveness of rib fixation compared to pain medication alone on pain control in patients with uncomplicated rib fractures: study protocol of a pragmatic multicenter randomized controlled trial-the PAROS study (Pain After Rib OSteosynthesis). Trials. 2022 Sep 2;23(1):732. doi: 10.1186/s13063-022-06509-0.