The Pain Control in Rib Fracture With Non-invasive Stabilization (RCT)
- Conditions
- Thorax; FractureRib FracturesPain
- Interventions
- Device: Posthorax Thoraxbelt
- Registration Number
- NCT05080686
- Lead Sponsor
- National Taiwan University Hospital Hsin-Chu Branch
- 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 112
- 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)
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ThoraxBelt (Inpatients) Posthorax Thoraxbelt 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). ThoraxBelt (Outpatients) Posthorax Thoraxbelt 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).
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Inpatients: On-request oral painkiller dose 48 hours the accumulated oral painkiller dose
Inpatients: Complication during the hospital stay 48 hours Any complications whether related to ThoraxBelt or not
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
Outpatients: The amount of unanticipated events 3 months send to the ward admission, ICU admission, a surgery or OHCA
Inpatients: Length of hospital stay 1 month the amount of days in hospital stay
Inpatients: The amount of unanticipated events 3 months send to the ICU admission, a second surgery or death
Inpatients: VAS before discharge 3 months Visual analog scale before discharge
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
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
Trial Locations
- Locations (1)
National Taiwan University Hospital Hsin-Chu Branch
🇨🇳Hsinchu, Taiwan