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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05080686
• Other study ID #: 110-079-F
• Status: Recruiting
• Phase: N/A
• 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
• 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)

Related Conditions & MeSH terms

• Fractures, Bone
• Pain
• Rib Fractures

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