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Pain as Indication for Operative Treatment of Traumatic Rib Fractures (potf)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02094807
Recruitment Status : Withdrawn (Slow inclusion rate. Awaiting results from NCT02132416.)
First Posted : March 24, 2014
Last Update Posted : July 12, 2018
Sponsor:
Collaborator:
Sahlgrenska University Hospital, Sweden
Information provided by (Responsible Party):
Eva-Corina Caragounis, Sahlgren´s University Hospital

Brief Summary:
The purpose of this prospective randomized controlled study is to determine whether acute and chronic pain in patients who suffer multiple traumatic rib fractures is decreased after surgical management as compared to conservative management.

Condition or disease Intervention/treatment Phase
Trauma Rib Fractures Surgery Pain Drug: NSAID Procedure: thoracic epidural anesthesia Drug: opioids Drug: paracetamol Procedure: operative fixation of rib fractures Not Applicable

Detailed Description:
Patients meeting the inclusion criteria and giving their informed consent will be enrolled in this prospective randomized controlled study. In total 60 patients will be randomized to either surgical or conservative management of rib fractures. 3D reconstructions of computed tomography images of the Thorax done at admission to hospital will be used in order to evaluate injury according to Lung Injury Scale and Chest wall Injury Scale and for calculating radiological lung volumes and plan surgical procedure in the intervention group. Surgery will be performed as soon as possible after randomization. MatrixRIB® (DePuy Synthes) Fixation system is used for stabilizing rib fractures with plates and angular locked screws. Unless there is a medical indication or the patient has a chest tube pre-operatively, thoracotomy will be avoided. In cases where thoracotomy is done the patients will receive an anterior and posterior chest tube and wound drain with active suction. All patients, both in the intervention and in the control group will be offered thoracic epidural anaesthesia. Broad-spectrum antibiotic therapy iv is given as long as the patient has chest tubes. Thrombotic prophylaxis with LMWH is given until the patient is mobilized but for a minimum of 7 days. Patients will be followed-up 6 weeks, 6 months and 1 year post-operatively by surgeon and physiotherapist. A low-dosage computer tomography of the thorax will be done after 6 months in order to evaluate healing of the rib cage, possible non-union or dysfunction of osteosynthetic material and measure remaining lung volume. This examination will be compared to the initial computer tomography image done when the patient was admitted. At follow-ups complaints, possible late complications, usage of analgesia and return to work will be recorded. Evaluated instruments, EQ-5D-5L, VAS with Pain-O-Meter (POM) and Disability Rating Index (DRI) will be used to evaluate quality of life, pain and physical function. Range of motion in the thorax, thoracic spine and shoulders will be evaluated for every patient. Breathing movements will be measured by using a Respiratory movement measuring instrument (RMMI, ReMo Inc) and lung function tests will be performed in a standardized manner.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Controlled Trial of Pain as Indication for Operative Treatment of Traumatic Rib Fractures.
Actual Study Start Date : April 2014
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Conservative management
Not operated. Thoracic epidural anesthesia will be used togeteher with paracetamol. If not sufficient opioids and NSAID will be added.
Drug: NSAID
Will be used if other drugs are not tolerated.
Other Names:
  • Tramadol
  • Voltaren
  • Naprosyn
  • Diclofenac

Procedure: thoracic epidural anesthesia
Continous epidural anesthesia will be introduced by specialists in Anesthesia and Intensive care.

Drug: opioids
During firs 24 hours i.v will be used. Then slow releas tabletts will be preferred.
Other Names:
  • Oxycotin
  • Oxynorm
  • Oxycodone
  • Morfin

Drug: paracetamol
100mg x 4 i.v. during the first 24 hours. Then orally 100mg x 4.
Other Names:
  • Paracet
  • Alvedon
  • Panodil

Active Comparator: Operative management
Operative fixation of rib fractures. Thoracic epidural anesthesia will be used togeteher with paracetamol. If not sufficient opioids and NSAID will be added.
Drug: NSAID
Will be used if other drugs are not tolerated.
Other Names:
  • Tramadol
  • Voltaren
  • Naprosyn
  • Diclofenac

Procedure: thoracic epidural anesthesia
Continous epidural anesthesia will be introduced by specialists in Anesthesia and Intensive care.

Drug: opioids
During firs 24 hours i.v will be used. Then slow releas tabletts will be preferred.
Other Names:
  • Oxycotin
  • Oxynorm
  • Oxycodone
  • Morfin

Drug: paracetamol
100mg x 4 i.v. during the first 24 hours. Then orally 100mg x 4.
Other Names:
  • Paracet
  • Alvedon
  • Panodil

Procedure: operative fixation of rib fractures
Fractures will be stabilized on the outside of of the ribs.
Other Name: Matrix RIB Fixation Systems (De Puy Synthes)




Primary Outcome Measures :
  1. Pain: VAS (1-10) [ Time Frame: 1 year ]
    VAS (1-10)


Secondary Outcome Measures :
  1. time spent in hospital [ Time Frame: 6 weeks ]
    Length of stay

  2. EQ-5D-5L [ Time Frame: 1 year ]
    Quality of Life

  3. DRI [ Time Frame: 1 year ]
    Function and Activity


Other Outcome Measures:
  1. The total cost [ Time Frame: 1 year ]
    Adding time spent in hospital, on ICU or high-care unit and time before return to work



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Adults ≥18 years of age with traumatic rib fractures that meet the following 2 criteria:

  1. A minimum of 4 rib fractures
  2. Pain that requires analgesia in the form of opioids in equivalent doses of > 25 mg iv morphine daily

Exclusion Criteria:

  1. Concurrent spinal cord injuries with paralysis
  2. Severe head injury where normal level of consciousness is not present
  3. Severe neurological and musculoskeletal diseases that influence the function of the thoracic wall and lung volumes

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02094807


Locations
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Sweden
Sahlgrenska University Hospital
Gothenburg, Sweden, 413 45
Sponsors and Collaborators
Sahlgren´s University Hospital
Sahlgrenska University Hospital, Sweden
Investigators
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Study Director: Hans Granhed, MD PhD Sahlgrenska University Hospital, Sweden
Principal Investigator: Eva-Corina Caragounis, MD Sahlgrenska University Hospital, Sweden
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Responsible Party: Eva-Corina Caragounis, MD, Sahlgren´s University Hospital
ClinicalTrials.gov Identifier: NCT02094807    
Other Study ID Numbers: hg481115
epn887-13 ( Registry Identifier: Ethical approval committe )
First Posted: March 24, 2014    Key Record Dates
Last Update Posted: July 12, 2018
Last Verified: July 2018
Keywords provided by Eva-Corina Caragounis, Sahlgren´s University Hospital:
prospective study
surgical management
rib fractures
trauma
Additional relevant MeSH terms:
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Fractures, Bone
Rib Fractures
Wounds and Injuries
Thoracic Injuries
Acetaminophen
Diclofenac
Oxycodone
Tramadol
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antipyretics
Analgesics, Opioid
Narcotics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action