Clinical trial NCT02094807: Pain as Indication for Operative Treatment of Traumatic Rib Fractures
Official title: A Prospective Randomized Controlled Trial of Pain as Indication for Operative Treatment of Traumatic Rib Fractures.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Trauma
Rib Fractures
Surgery
Pain
Keywords: prospective study
surgical management
rib fractures
trauma
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
First posted: 2014-03-24
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Pain: VAS (1-10)
timeFrame: 1 year
Secondary outcomes:
measure: time spent in hospital
timeFrame: 6 weeks
measure: EQ-5D-5L
timeFrame: 1 year
measure: DRI
timeFrame: 1 year
Other outcomes:
measure: The total cost
timeFrame: 1 year
Locations:
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
Study officials:
affiliation: Sahlgrenska University Hospital
name: Hans Granhed, MD PhD
role: STUDY_DIRECTOR
affiliation: Sahlgrenska University Hospital
name: Eva-Corina Caragounis, MD
role: PRINCIPAL_INVESTIGATOR
References: