Sahlgrenska University Hospital
Gothenburg, 413 45, Sweden
NCT Number: NCT02094807
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Gothenburg, 413 45, Sweden
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Adults ≥18 years of age with traumatic rib fractures that meet the following 2 criteria:
Exclusion criteria
Will be used if other drugs are not tolerated.
Other names: Tramadol, Voltaren, Naprosyn, Diclofenac
Continous epidural anesthesia will be introduced by specialists in Anesthesia and Intensive care.
During firs 24 hours i.v will be used. Then slow releas tabletts will be preferred.
Other names: Oxycotin, Oxynorm, Oxycodone, Morfin
100mg x 4 i.v. during the first 24 hours. Then orally 100mg x 4.
Other names: Paracet, Alvedon, Panodil
Fractures will be stabilized on the outside of of the ribs.
Other names: Matrix RIB Fixation Systems (De Puy Synthes)
Time frame: 1 year
Visual Analogue Scale (VAS) (1-10; 1 better and 10 worse)
Time frame: 6 weeks
Length of stay
Time frame: 1 year
Quality of Life
Time frame: 1 year
Function and Activity
Time frame: 1 year
Adding time spent in hospital, on ICU or high-care unit and time before return to work
Sahlgrenska University Hospital
Other
A Prospective Randomized Controlled Trial of Pain as Indication for Operative Treatment of Traumatic Rib Fractures.
Acronym: potf
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05865327
Accidental Injuries, Acute Pain
Toronto, Ontario, Canada
View Trial DetailsNCT02132416
Flail Chest, Fractures, Bone
Gothenburg, Sweden
View Trial DetailsNCT06533904
Chest Pain, Chest Wall Disorder
Loma Linda, California, United States
View Trial DetailsNCT04705480
Analgesics, Gabapentin
Charleston, West Virginia, United States
View Trial Details