NCT05080686

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 112 (estimated)
• Sponsor: National Taiwan University Hospital Hsin-Chu Branch · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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

Conditions

• Rib Fractures
• Pain
• Thorax; Fracture

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-01-01
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2021-10-18
• Last updated: 2022-07-19

Locations

1 site across 1 country: Taiwan