Pain, Rib Fractures, Thorax; Fracture
Conditions
Keywords
Rib fractures, pain control, Posthorax Thoraxbelt
Brief summary
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.
Detailed description
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
Interventions
DEVICEPosthorax Thoraxbelt
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.
Sponsors
National Taiwan University Hospital Hsin-Chu Branch
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Masking description
The surgeon will not know the patients' group before or during the surgery. The outcome assessor will not know the group during the whole research.
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The adult patients with rib fractures (inpatients/outpatients) * The patients will be assessed to the further admission (inpatients) * The patients will be assessed to be at follow-up clinic visit (outpatients)
Exclusion criteria
* The accident of rib fractures has been occurred over 24 hours. (inpatients/outpatients) * Refuse to be arranged to the admission (inpatients) * Refuse to receive the CT scan (inpatients/outpatients) * Chest wall infection or other diseases (inpatients/outpatients) * Chest wall infected by rumors (inpatients/outpatients) * Pregnancy (inpatients/outpatients) * Further complications arise (inpatients/outpatients) * Known allergy to ThoraxBelt (inpatients/outpatients)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Inpatients: Visual analog scale (VAS) | 48 hours | 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. |
| Outpatients: Visual analog scale (VAS) | 3 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Inpatients: Complication during the hospital stay | 48 hours | Any complications whether related to ThoraxBelt or not |
| Inpatients: Length of hospital stay | 1 month | the amount of days in hospital stay |
| Inpatients: VAS before discharge | 3 months | Visual analog scale before discharge |
| Inpatients: The amount of unanticipated events | 3 months | send to the ICU admission, a second surgery or death |
| Inpatients: IV PCA dose | 48 hours | the accumulated IV PCA drug dose |
| Inpatients/Outpatients: X-ray examination | 3 months | An X-ray examination at an outpatient clinic |
| Inpatients/Outpatients: Compliance on ThoraxBelt after discharge | 3 months | How long is the ThroaxBelt removed except during the bath within the whole day. The unit is hour. |
| Outpatients: Complication during the follow-up period | 6 months | Any complications whether related to ThoraxBelt or not |
| Outpatients: The amount of unanticipated events | 3 months | send to the ward admission, ICU admission, a surgery or OHCA |
| Inpatients: VAS in outpatient clinic follow-up | 3 months | VAS during the 1-week, 1-month and 3-month outpatient clinic visit after the surgery |
| Inpatients: On-request oral painkiller dose | 48 hours | the accumulated oral painkiller dose |
Countries
Taiwan
Contacts
Primary ContactCheng-Yi Fan, M.D.
Outcome results
None listed