Brief summary: Background: Rib fractures are one of the most common causes of trauma disabilities and have become an important health issue. Patients usually suffer from severe pain. A rapid and adequate pain control is considered as a priority to improve respiratory mechanics and reduce the risk of pulmonary and systemic complications. So far, there was no gold standard regarding pain control for rib fractures. Objective: To assess the effect of the newly-designed Prosthorax Thoraxbelt in addition to oral analgesics on pain control of rib fractures Method: There will be two groups of patients in this study. One group will be the patients with rib fractures who are necessary for in-hospital intense pain control. The other will consist of follow-up patients with rib fractures at an outpatient clinic. The investigators will aim to recruit 30 and 82 patients respectively.
The study has been approved by the hospital research ethics committee. Arm1: The management and assessment of pain control in rib fracture with non-invasive stabilization: a randomized controlled trial (inpatients) Arm2: The management and assessment of pain control in rib fracture with non-invasive stabilization: a randomized controlled trial (outpatients) Primary outcome: 1. inpatient: Visual analog scale (VAS) for 6 hours, 12 hours and 24 hours after the surgery 2. outpatient: Visual analog scale (VAS) for the times at emergency room; 3 days, 3 weeks and 3 months after rib fracture at an outpatient clinic. Secondary outcome: * inpatients 1. The accumulated dose of the inter-venous patient-controlled analgesic drug within 6 hours, 24 hours and 48 hours after the surgery 2. Complication during the hospital stay 3. Hospital stay 4. VAS before discharge 5. Unanticipated events (ICU admission, a second surgery, death) 6. VAS during the 1-week, 1-month and 3-month outpatient clinic visit after the surgery 7. An X-ray examination at an outpatient clinic 8. Compliance on ThoraxBelt after discharge * outpatients 1. Complication during the follow-up period 2. Unanticipated events (ward admission, ICU admission, a surgery, OHCA) 3. Compliance on ThoraxBelt after discharge 4. An X-ray examination at an outpatient clinic
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
112
The patients will be assisted to put on the ThoraxBelt after surgery or at the emergency room by our research members and will be asked to keep it on except for showering through the whole study period.
National Taiwan University Hospital Hsin-Chu Branch
Hsinchu, Taiwan
RECRUITINGInpatients: Visual analog scale (VAS)
A pain score will be assessed to each patient after the total amount of visual analog scale. The minimum is 0 and the maximum is 10, from the least pain to the highest pain.
Time frame: 48 hours
Outpatients: Visual analog scale (VAS)
A pain score will be assessed to each patient after the total amount of visual analog scale. The minimum is 0 and the maximum is 10, from the l
Time frame: 3 months
Inpatients: IV PCA dose
the accumulated IV PCA drug dose
Time frame: 48 hours
Inpatients: On-request oral painkiller dose
the accumulated oral painkiller dose
Time frame: 48 hours
Inpatients: Complication during the hospital stay
Any complications whether related to ThoraxBelt or not
Time frame: 48 hours
Inpatients: Length of hospital stay
the amount of days in hospital stay
Time frame: 1 month
Inpatients: VAS before discharge
Visual analog scale before discharge
Time frame: 3 months
Inpatients: The amount of unanticipated events
send to the ICU admission, a second surgery or death
Time frame: 3 months
Inpatients: VAS in outpatient clinic follow-up
VAS during the 1-week, 1-month and 3-month outpatient clinic visit after the surgery
Time frame: 3 months
Inpatients/Outpatients: X-ray examination
An X-ray examination at an outpatient clinic
Time frame: 3 months
Inpatients/Outpatients: Compliance on ThoraxBelt after discharge
How long is the ThroaxBelt removed except during the bath within the whole day. The unit is hour.
Time frame: 3 months
Outpatients: Complication during the follow-up period
Any complications whether related to ThoraxBelt or not
Time frame: 6 months
Outpatients: The amount of unanticipated events
send to the ward admission, ICU admission, a surgery or OHCA
Time frame: 3 months
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