The Pain Control in Rib Fracture With Non-invasive Stabilization (RCT)

Study Overview
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Brief Summary
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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.

Detailed Description
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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: inpatient: Visual analog scale (VAS) for 6 hours, 12 hours and 24 hours after the surgery 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 The accumulated dose of the inter-venous patient-controlled analgesic drug within 6 hours, 24 hours and 48 hours after the surgery Complication during the hospital stay Hospital stay VAS before discharge Unanticipated events (ICU admission, a second surgery, death) VAS during the 1-week, 1-month and 3-month outpatient clinic visit after the surgery An X-ray examination at an outpatient clinic Compliance on ThoraxBelt after discharge outpatients Complication during the follow-up period Unanticipated events (ward admission, ICU admission, a surgery, OHCA) Compliance on ThoraxBelt after discharge An X-ray examination at an outpatient clinic

Official Title
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The Management and Assessment of Pain Control in Rib Fracture With Non-invasive Stabilization: a Randomized Controlled Trial

Conditions
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Rib Fractures, Pain, Thorax; Fracture

Intervention / Treatment
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* Device: Posthorax Thoraxbelt


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ThoraxBelt (Inpatients)<br>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). | Device: Posthorax Thoraxbelt<br>* 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.<br>|
| No Intervention: Standard Care (Inpatients)<br>Standard Care with IV PCA and on-request oral painkiller. | |
| Experimental: ThoraxBelt (Outpatients)<br>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). | Device: Posthorax Thoraxbelt<br>* 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.<br>|
| No Intervention: Standard Care (Outpatients)<br>Standard Care and on-request oral painkiller. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain control, Posthorax Thoraxbelt, Rib fractures