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

Not Applicable

• Conditions: Thorax; Fracture; Rib Fractures; Pain

• 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

Study Timeline

• Status Verified: 2021-10
• Study First Submitted: 2021-10-04
• Study First Submitted QC: 2021-10-04
• Study First Posted: 2021-10-18
• Study Start: 2022-01-01
• Last Update Submitted: 2022-07-17
• Last Update Posted: 2022-07-19
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 112

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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