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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
102
Rib fixation is performed by a senior surgeon. The patient is under general anesthesia. A thoracotomy focused on the fracture is performed to optimize access to the rib to be repaired. Video-assisted thoracic surgery (VATS) can be performed to better localize rib fractures. Significant muscle division is avoided. Removal of the periosteum is not required. The broken rib segments are approximated with forceps and the medical devices are used to fix the fracture. The medical devices are implemented according to the manufacturers' recommendations. The goal is to stabilize the chest wall. It is not useful to fix all fractures to stabilize the wall. A chest tube can be placed at the end of the operation. Medical devices The following medical devices can be used: * MatrixRIB™, De Puy Synthes Companies, Zuchwill, Switzerland * STRATOS™, MedXpert GmbH, Heitersheim, Germany * NiTi Fixing PlatesTM, IAWAI, Yandzhou, China
Epidural analgesia is continuing for 24 to 72 hours post-randomization to maximize outcome benefits. Afterwards, paracetamol, NSAID and/or opioid treatment are used according to pain severity. In case of opioid use, morphine treatment is preferred. However, other opioid drugs or doses can be considered to better customize the treatment.
Unit of Thoracic and Endocrine Surgery, University Hospitals of Geneva
Geneva, Switzerland
Pain severity
Pain level reported by the participant, as assessed via the first part of the French version of the brief pain inventory (BPI) questionnaire. 0-10 scale. 10 indicating worst pain
Time frame: Two months after injury
Pain severity
Pain level reported by the participant, as assessed via the first part of the French version of the brief pain inventory (BPI) questionnaire. 0-10 scale. 10 indicating worst pain
Time frame: At recruitment (baseline)
Pain severity
Pain level reported by the participant, as assessed via the first part of the French version of the brief pain inventory (BPI) questionnaire. 0-10 scale. 10 indicating worst pain
Time frame: One month after injury
Pain severity
Pain level reported by the participant, as assessed via the first part of the French version of the brief pain inventory (BPI) questionnaire. 0-10 scale. 10 indicating worst pain
Time frame: Three months after injury
Pain severity
Pain level reported by the participant, as assessed via the first part of the French version of the brief pain inventory (BPI) questionnaire. 0-10 scale. 10 indicating worst pain
Time frame: Six months after injury
Pain severity
Pain level reported by the participant, as assessed via the first part of the French version of the brief pain inventory (BPI) questionnaire. 0-10 scale. 10 indicating worst pain
Time frame: Twelve months after injury
Anxiety and Depression.
hospital anxiety and depression scale (HADS). Score 0-21. 21 = severe depression or anxiety
Time frame: At recruitment (baseline)
Anxiety and Depression.
hospital anxiety and depression scale (HADS). Score 0-21. 21 = severe depression or anxiety
Time frame: One month after injury
Anxiety and Depression.
hospital anxiety and depression scale (HADS). Score 0-21. 21 = severe depression or anxiety
Time frame: Two months after injury
Neuropathic pain
The French questionnaire "Douleur Neuropathique en 4 Questions (DN4)" is completed by an investigator during follow-up visits. The DN4 questionnaire was developed to diagnose polyneuropathy. Three items are linked with neuropathic pain examination, and seven items to pain symptoms. Score 0-10. Score \>4 indicates neuropathic pain.
Time frame: Two months after injury
Neuropathic pain
The French questionnaire "Douleur Neuropathique en 4 Questions (DN4)" is completed by an investigator during follow-up visits. The DN4 questionnaire was developed to diagnose polyneuropathy. Three items are linked with neuropathic pain examination, and seven items to pain symptoms. Score 0-10. Score \>4 indicates neuropathic pain.
Time frame: Six months after injury
Pain interference
The last items of the BPI questionnaires measure how much pain has interfered with seven daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others and sleep. BPI pain interference is scored as the mean of the seven items. Score 0-10. 10 = high interference of pain with activities.
Time frame: At recruitment (baseline)
Pain interference
The last items of the BPI questionnaires measure how much pain has interfered with seven daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others and sleep. BPI pain interference is scored as the mean of the seven items. Score 0-10. 10 = high interference of pain with activities.
Time frame: One month after injury
Pain interference
The last items of the BPI questionnaires measure how much pain has interfered with seven daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others and sleep. BPI pain interference is scored as the mean of the seven items. Score 0-10. 10 = high interference of pain with activities.
Time frame: Two months after injury
Pain interference
The last items of the BPI questionnaires measure how much pain has interfered with seven daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others and sleep. BPI pain interference is scored as the mean of the seven items. Score 0-10. 10 = high interference of pain with activities.
Time frame: Three months after injury
Pain interference
The last items of the BPI questionnaires measure how much pain has interfered with seven daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others and sleep. BPI pain interference is scored as the mean of the seven items. Score 0-10. 10 = high interference of pain with activities.
Time frame: Six months after injury
Pain interference
The last items of the BPI questionnaires measure how much pain has interfered with seven daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others and sleep. BPI pain interference is scored as the mean of the seven items. Score 0-10. 10 = high interference of pain with activities.
Time frame: Twelve months after injury
Health and well being
The 36-Item Health Survey (SF-36) taps eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. Score: 0-100. 100 = better functioning
Time frame: At recruitment (baseline)
Health and well being
The 36-Item Health Survey (SF-36) taps eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. Score: 0-100. 100 = better functioning
Time frame: Two months after injury
Health and well being
The 36-Item Health Survey (SF-36) taps eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. Score: 0-100. 100 = better functioning
Time frame: Six months after injury
Analgesic medication during hospitalisation
During hospitalization, each day since the enrolment, amount and type of analgesic medication are recorded from the computerized patient record system.
Time frame: At recruitement (baseline)
Analgesic medication at home
After discharge, analgesic medication (type and amount) is tracked using a custom questionnaire.
Time frame: One month after injury
Analgesic medication at home
After discharge, analgesic medication (type and amount) is tracked using a custom questionnaire.
Time frame: Two months after injury
Analgesic medication at home
After discharge, analgesic medication (type and amount) is tracked using a custom questionnaire.
Time frame: Three months after injury
Analgesic medication at home
After discharge, analgesic medication (type and amount) is tracked using a custom questionnaire.
Time frame: Six months after injury
Analgesic medication at home
After discharge, analgesic medication (type and amount) is tracked using a custom questionnaire.
Time frame: Twelve months after injury
Productivity & return to work
The work productivity and activity impairment (WPAI) questionnaire is used. It assesses impairments in both paid work and unpaid work. It measures absenteeism, presenteeism as well as the impairments in unpaid activity because of health problem during the past seven days. Score 0-10. 10 = high impairment
Time frame: One month after injury
Productivity & return to work
The work productivity and activity impairment (WPAI) questionnaire is used. It assesses impairments in both paid work and unpaid work. It measures absenteeism, presenteeism as well as the impairments in unpaid activity because of health problem during the past seven days. Score 0-10. 10 = high impairment
Time frame: Two months after injury
Productivity & return to work
The work productivity and activity impairment (WPAI) questionnaire is used. It assesses impairments in both paid work and unpaid work. It measures absenteeism, presenteeism as well as the impairments in unpaid activity because of health problem during the past seven days. Score 0-10. 10 = high impairment
Time frame: Three months after injury
Productivity & return to work
The work productivity and activity impairment (WPAI) questionnaire is used. It assesses impairments in both paid work and unpaid work. It measures absenteeism, presenteeism as well as the impairments in unpaid activity because of health problem during the past seven days. Score 0-10. 10 = high impairment
Time frame: Six months after injury
Productivity & return to work
The work productivity and activity impairment (WPAI) questionnaire is used. It assesses impairments in both paid work and unpaid work. It measures absenteeism, presenteeism as well as the impairments in unpaid activity because of health problem during the past seven days. Score 0-10. 10 = high impairment
Time frame: Twelve months after injury
Pulmonary function
Forced vital capacity (FVC, % predicted) measured according to the recommendations of the European Respiratory Society. The best value of at least three tests is recorded.
Time frame: Two months after injury
Pulmonary function, forced vital capacity
Forced vital capacity (FVC, % predicted) measured according to the recommendations of the European Respiratory Society. The best value of at least three tests is recorded.
Time frame: Six months after injury
Pulmonary function, peak expiratory flow
Peak expiratory flow (PEF, L/min) measured according to the recommendations of the European Respiratory Society. The best value of at least three tests is recorded.
Time frame: Two months after injury
Pulmonary function, peak expiratory flow
Peak expiratory flow (PEF, L/min) measured according to the recommendations of the European Respiratory Society. The best value of at least three tests is recorded.
Time frame: Six months after injury
Pulmonary function, sniff nasal inspiratory pressure
sniff nasal inspiratory pressure (in in cmH2O) measured according to the recommendations of the European Respiratory Society. The best value of at least three tests is recorded.
Time frame: Two months after injury
Pulmonary function, sniff nasal inspiratory pressure
sniff nasal inspiratory pressure (in in cmH2O) measured according to the recommendations of the European Respiratory Society. The best value of at least three tests is recorded.
Time frame: Six months after injury
Pulmonary function, inspiratory pressure
Maximum inspiratory pressure (in in cmH2O) measured according to the recommendations of the European Respiratory Society. The best value of at least three tests is recorded.
Time frame: Two months after injury
Pulmonary function, inspiratory pressure
Maximum inspiratory pressure (in in cmH2O) measured according to the recommendations of the European Respiratory Society. The best value of at least three tests is recorded.
Time frame: Six months after injury
Length of hospital stay
Length of hospital stay is reported in days from the day of hospitalization until the hospital discharge. The length of convalescence stay is also reported.
Time frame: from admission to discharge, up to four weeks
Total costs
Costs are reported at the end of the follow-up period (12 months) in swiss francs. They include costs for hospital treatment and costs for medication.
Time frame: Twelve months after injury
Adverse events
We collect safety outcomes in accordance with international standards (ISO 14155 and ICH-GCP)
Time frame: From inclusion to the end of the study, up to 12 months
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