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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05080686
Other study ID # 110-079-F
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 1, 2022
Est. completion date December 31, 2022

Study information

Verified date October 2021
Source National Taiwan University Hospital Hsin-Chu Branch
Contact Cheng-Yi Fan, M.D.
Phone +886911438312
Email chengyi.md@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Recruiting
Enrollment 112
Est. completion date December 31, 2022
Est. primary completion date December 31, 2022
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Posthorax 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.

Locations

Country Name City State
Taiwan National Taiwan University Hospital Hsin-Chu Branch Hsinchu

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan University Hospital Hsin-Chu Branch

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 Inpatients: IV PCA dose the accumulated IV PCA drug dose 48 hours
Secondary Inpatients: On-request oral painkiller dose the accumulated oral painkiller dose 48 hours
Secondary Inpatients: Complication during the hospital stay Any complications whether related to ThoraxBelt or not 48 hours
Secondary Inpatients: Length of hospital stay the amount of days in hospital stay 1 month
Secondary Inpatients: VAS before discharge Visual analog scale before discharge 3 months
Secondary Inpatients: The amount of unanticipated events send to the ICU admission, a second surgery or death 3 months
Secondary 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
Secondary Inpatients/Outpatients: X-ray examination An X-ray examination at an outpatient clinic 3 months
Secondary 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
Secondary Outpatients: Complication during the follow-up period Any complications whether related to ThoraxBelt or not 6 months
Secondary Outpatients: The amount of unanticipated events send to the ward admission, ICU admission, a surgery or OHCA 3 months
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