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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:
Secondary outcome:
inpatients
outpatients
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ThoraxBelt (Inpatients) | Experimental | Received ThoraxBelt after the surgery in addition to oral analgesics. Standard care for pain management will be the same as the Standard Care Arm (Inpatients). |
|
| Standard Care (Inpatients) | No Intervention | Standard Care with IV PCA and on-request oral painkiller. | |
| ThoraxBelt (Outpatients) | Experimental | Received ThoraxBelt at the emergency room in addition to oral analgesics. Standard care for pain management will be the same as the Standard Care Arm (Outpatients). |
|
| Standard Care (Outpatients) | No Intervention | Standard Care and on-request oral painkiller. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Posthorax Thoraxbelt | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Inpatients: 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. | 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 | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Inpatients: IV PCA dose | the accumulated IV PCA drug dose | 48 hours |
| Inpatients: On-request oral painkiller dose | the accumulated oral painkiller dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cheng-Yi Fan, M.D. | Contact | +886911438312 | chengyi.md@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital Hsin-Chu Branch | Recruiting | Hsinchu | 300 | Taiwan |
Currently, we have no plan on sharing the IPD.
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| ID | Term |
|---|---|
| D012253 | Rib Fractures |
| D010146 | Pain |
| D050723 | Fractures, Bone |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D013898 | Thoracic Injuries |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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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.
| 48 hours |
| Inpatients: Complication during the hospital stay | Any complications whether related to ThoraxBelt or not | 48 hours |
| Inpatients: Length of hospital stay | the amount of days in hospital stay | 1 month |
| Inpatients: VAS before discharge | Visual analog scale before discharge | 3 months |
| Inpatients: The amount of unanticipated events | send to the ICU admission, a second surgery or death | 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 | 3 months |
| Inpatients/Outpatients: X-ray examination | An X-ray examination at an outpatient clinic | 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. | 3 months |
| Outpatients: Complication during the follow-up period | Any complications whether related to ThoraxBelt or not | 6 months |
| Outpatients: The amount of unanticipated events | send to the ward admission, ICU admission, a surgery or OHCA | 3 months |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |